Ignite Creation Date:
2025-12-24 @ 3:19 PM
Ignite Modification Date:
2026-01-25 @ 5:18 PM
Study NCT ID:
NCT03945292
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2019-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Ireland', 'Sweden'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PObrien@arrowheadpharma.com', 'phone': '626-304-3400', 'title': "Patrick O'Brien, Chief Operating Officer", 'organization': 'Arrowhead Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor retains first right to publish results for this multi-center study, and thereafter can review results communications prior to release and can embargo communications regarding trial results for a period that is 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication of results but can require removal of its confidential information (excluding results).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants without fibrosis: for a maximum duration of follow up of 66 weeks. Participants with evidence of fibrosis: for a maximum duration of follow up of 210 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Fazirsiran 25 mg DB/200 mg OL', 'description': 'Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 25 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Fazirsiran 100 mg DB/200 mg OL', 'description': 'Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 100 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Fazirsiran 200 mg DB/200 mg OL', 'description': 'Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 200 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Placebo DB / Fazirsiran 200 mg OL', 'description': 'Participants with fibrosis at Screening who received double-blind (DB) placebo and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Left atrial enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hamartoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 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{'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Poor venous access', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Withdrawal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infective exacerbation of bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Serum Z-Alpha-1 Antitrypsin (Z-AAT) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '-62.17', 'spread': '4.279', 'groupId': 'OG000'}, {'value': '-85.39', 'spread': '4.634', 'groupId': 'OG001'}, {'value': '-92.93', 'spread': '4.341', 'groupId': 'OG002'}, {'value': '4.64', 'spread': '3.211', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-66.81', 'ciLowerLimit': '-77.18', 'ciUpperLimit': '-56.45', 'pValueComment': 'From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.107', 'statisticalMethod': 'Mixed model repeated measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'NAFLD=non-alcoholic fatty liver disease; NSH=non-alcoholic steatohepatitis'}, {'pValue': '< 0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-90.03', 'ciLowerLimit': '-100.72', 'ciUpperLimit': '-79.34', 'pValueComment': 'From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.26', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-97.57', 'ciLowerLimit': '-108.21', 'ciUpperLimit': '-86.94', 'pValueComment': 'From a mixed model with repeated measures, including fixed effects for treatment, week, treatment-by-week interaction, presence of metabolic syndrome, presence of NAFLD or NASH, baseline serum Z-AAT as covariate, and subject as a random effect.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.24', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 16 (+/- 2 weeks)', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Leading to Withdrawal of Study Drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Leading to Study Termination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Leading to Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Severity: Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Severity: Moderate', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Severity: Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Relationship: Not Related', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Relationship: Possibly Related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Relationship: Probably Related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Relationship: Possibly or Probably', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'TEAE at Injection Site', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Double Blind Phase (up to Week 48): dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.', 'description': 'An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. TEAEs/TESAEs are defined as those AEs that first occurred or worsened in severity following dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who receive at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Leading to Withdrawal of Study Drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Leading to Study Termination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs Leading to Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Severity: Mild', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Severity: Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Severity: Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Relationship: Not Related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Relationship: Possibly Related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Relationship: Probably Related', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'TEAEs by Worst Relationship: Possibly or Probably', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'TEAE at Injection Site', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From dose administration of the first dose of open-label phase fazirsiran through EOS or Early Termination (up to Week 196).', 'description': 'An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. TEAEs/TESAEs are defined as those AEs that first occurred or worsened in severity following dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: All participants who receive at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Total Liver Z-AAT (Insoluble + Soluble) Protein at Post-dose Biopsy for Participants With Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '-89.341', 'spread': '94.832', 'groupId': 'OG000'}, {'value': '-259.892', 'spread': '330.199', 'groupId': 'OG001'}, {'value': '-29.371', 'spread': '22.867', 'groupId': 'OG002'}, {'value': '-4.738', 'spread': '57.342', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.', 'unitOfMeasure': 'nmol/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Total Liver Z-AAT (Insoluble + Soluble) Protein at Post-dose Biopsy for Participants With Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '-86.89', 'spread': '29.658', 'groupId': 'OG000'}, {'value': '-81.61', 'spread': '29.503', 'groupId': 'OG001'}, {'value': '-98.16', 'spread': '23.256', 'groupId': 'OG002'}, {'value': '42.42', 'spread': '21.133', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-129.31', 'ciLowerLimit': '-205.52', 'ciUpperLimit': '-53.11', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '36.409', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0035', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-124.03', 'ciLowerLimit': '-201.9', 'ciUpperLimit': '-46.15', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.207', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-140.58', 'ciLowerLimit': '-205.27', 'ciUpperLimit': '-75.89', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline total liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '30.906', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Z-AAT Soluble Protein at Post-dose Biopsy for Participants With Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.427', 'spread': '15.042', 'groupId': 'OG000'}, {'value': '-109.747', 'spread': '135.114', 'groupId': 'OG001'}, {'value': '-17.418', 'spread': '4.860', 'groupId': 'OG002'}, {'value': '2.300', 'spread': '12.940', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.', 'unitOfMeasure': 'nmol/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Z-AAT Soluble Protein at Post-dose Biopsy for Participants With Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '-75.73', 'spread': '16.645', 'groupId': 'OG000'}, {'value': '-87.23', 'spread': '17.064', 'groupId': 'OG001'}, {'value': '-95.71', 'spread': '12.824', 'groupId': 'OG002'}, {'value': '22.33', 'spread': '11.890', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-98.07', 'ciLowerLimit': '-140.53', 'ciUpperLimit': '-55.6', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.291', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-109.56', 'ciLowerLimit': '-154.81', 'ciUpperLimit': '-64.32', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '21.616', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '< 0.0001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-118.04', 'ciLowerLimit': '-153.95', 'ciUpperLimit': '-82.12', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline soluble liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '17.16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Z-AAT Insoluble Protein at Post-dose Biopsy for Participants With Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '-68.914', 'spread': '80.725', 'groupId': 'OG000'}, {'value': '-150.145', 'spread': '196.675', 'groupId': 'OG001'}, {'value': '-11.953', 'spread': '18.602', 'groupId': 'OG002'}, {'value': '-7.038', 'spread': '47.041', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.', 'unitOfMeasure': 'nmol/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Z-AAT Insoluble Protein at Post-dose Biopsy for Participants With Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '-86.36', 'spread': '60.305', 'groupId': 'OG000'}, {'value': '-72.44', 'spread': '58.358', 'groupId': 'OG001'}, {'value': '-101.85', 'spread': '47.495', 'groupId': 'OG002'}, {'value': '91.35', 'spread': '42.750', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0247', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-180.7', 'ciLowerLimit': '-335.77', 'ciUpperLimit': '-25.64', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '74.087', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0382', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-163.79', 'ciLowerLimit': '-317.65', 'ciUpperLimit': '-9.93', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '73.513', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0064', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-193.2', 'ciLowerLimit': '-325.25', 'ciUpperLimit': '-61.15', 'pValueComment': 'Model based summary statistics are from an analysis of covariance (ANCOVA) model with fixed effect factors treatment group and baseline insoluble liver Z-AAT protein as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '63.089', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '9.17', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '5.42', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '15.88', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '6.60', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '11.93', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '3.59', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '2.86', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '5.31', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.7', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '-5.8', 'spread': '9.56', 'groupId': 'OG001'}, {'value': '0.6', 'spread': '6.48', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '6.91', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.6', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '8.78', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '9.79', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '4.66', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.5', 'spread': '10.47', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '16.00', 'groupId': 'OG001'}, {'value': '-2.2', 'spread': '5.31', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '7.71', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '12.31', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '7.39', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '33.80', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '4.44', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.8', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '-14.3', 'spread': '8.88', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '8.30', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '15.48', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '-14.8', 'spread': '9.07', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '8.24', 'groupId': 'OG002'}, {'value': '7.7', 'spread': '8.85', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.0', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '-18.5', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '4.97', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '7.76', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-21.0', 'spread': '5.66', 'groupId': 'OG001'}, {'value': '12.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '12.73', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.0', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '-21.5', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '7.5', 'spread': '7.78', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '9.43', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '7.07', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '4.24', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '6.43', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-18.0', 'spread': '4.24', 'groupId': 'OG001'}, {'value': '7.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '11.53', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '8.3', 'spread': '17.90', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '14.98', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '4.24', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.90', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '16.64', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '5.66', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '5.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '19.9', 'groupId': 'OG001'}, {'value': '-15.3', 'spread': '16.2', 'groupId': 'OG002'}, {'value': '5.8', 'spread': '16.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.7', 'spread': '24.8', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '-10.8', 'spread': '17.6', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '13.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-27.4', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '25.1', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '29.3', 'groupId': 'OG002'}, {'value': '6.4', 'spread': '21.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '24.0', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '20.0', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '18.3', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-21.7', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '38.2', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': '20.5', 'groupId': 'OG002'}, {'value': '5.9', 'spread': '15.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '32.9', 'groupId': 'OG000'}, {'value': '-15.2', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '28.5', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '14.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-22.3', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '-33.3', 'spread': '15.5', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '35.8', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '29.3', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.3', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-20.0', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '-33.7', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '24.6', 'spread': '43.6', 'groupId': 'OG002'}, {'value': '26.3', 'spread': '34.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-24.1', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-39.8', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '28.2', 'spread': '32.6', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '28.6', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-45.7', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '60.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '44.8', 'spread': '58.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-31.0', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '-46.4', 'spread': '15.2', 'groupId': 'OG001'}, {'value': '38.1', 'spread': '38.1', 'groupId': 'OG002'}, {'value': '9.9', 'spread': '24.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-27.6', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-38.9', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '41.4', 'spread': '19.2', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '24.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-39.3', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '35.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '25.2', 'spread': '49.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '40.1', 'spread': '79.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '25.5', 'spread': '61.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.8', 'spread': '3.0', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.3', 'spread': '65.0', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': '38.7', 'groupId': 'OG000'}, {'value': '-6.8', 'spread': '34.6', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '15.0', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '23.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '8.27', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '4.02', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '6.10', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '5.23', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.7', 'spread': '11.59', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '3.93', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '3.81', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.4', 'spread': '7.31', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '4.68', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '27.92', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '5.49', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '10.78', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '17.55', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '8.25', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '3.65', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': '10.42', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '4.16', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '5.22', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '6.40', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '9.89', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '8.46', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '15.92', 'groupId': 'OG002'}, {'value': '-0.9', 'spread': '2.93', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '10.24', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '10.40', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '4.42', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '7.70', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '8.85', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '5.78', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '7.20', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '-16.5', 'spread': '12.02', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '8.29', 'groupId': 'OG002'}, {'value': '4.2', 'spread': '6.57', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '5.66', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.5', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-21.5', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.12', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '4.76', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-19.0', 'spread': '14.14', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '7.00', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.5', 'spread': '10.61', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '9.29', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '10.60', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '11.14', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '4.95', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '8.33', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '9.19', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '3.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '20.0', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '16.4', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '2.5', 'spread': '14.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.9', 'spread': '24.2', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '17.6', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '9.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-19.3', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '26.8', 'spread': '68.8', 'groupId': 'OG002'}, {'value': '3.2', 'spread': '17.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '26.9', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '43.4', 'groupId': 'OG001'}, {'value': '8.3', 'spread': '21.7', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '11.4', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-27.1', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '16.2', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '19.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '20.9', 'groupId': 'OG001'}, {'value': '17.3', 'spread': '40.3', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '9.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-20.5', 'spread': '23.3', 'groupId': 'OG000'}, {'value': '-21.4', 'spread': '15.4', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '16.8', 'groupId': 'OG002'}, {'value': '9.5', 'spread': '21.6', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-17.1', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-22.2', 'spread': '13.9', 'groupId': 'OG001'}, {'value': '11.9', 'spread': '22.6', 'groupId': 'OG002'}, {'value': '30.3', 'spread': '32.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.4', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '-30.6', 'spread': '15.7', 'groupId': 'OG001'}, {'value': '18.1', 'spread': '34.7', 'groupId': 'OG002'}, {'value': '21.1', 'spread': '29.6', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-26.8', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}, {'value': '7.4', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '31.9', 'spread': '39.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-24.6', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '-40.5', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '7.9', 'groupId': 'OG002'}, {'value': '5.2', 'spread': '16.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-34.5', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-35.1', 'spread': '18.7', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '3.5', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '27.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-31.0', 'spread': '12.8', 'groupId': 'OG001'}, {'value': '-3.7', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '25.6', 'spread': '53.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.4', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '39.6', 'spread': '70.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '21.8', 'spread': '56.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55.2', 'spread': '25.7', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '26.9', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.7', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '35.1', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '31.5', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '17.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '6.50', 'groupId': 'OG001'}, {'value': '-13.8', 'spread': '14.26', 'groupId': 'OG002'}, {'value': '4.9', 'spread': '13.02', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.7', 'spread': '8.62', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '-11.7', 'spread': '14.83', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '6.62', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '12.29', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '6.88', 'groupId': 'OG001'}, {'value': '-8.4', 'spread': '13.53', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '5.51', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '15.51', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '-8.3', 'spread': '11.38', 'groupId': 'OG002'}, {'value': '1.6', 'spread': '7.43', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.5', 'spread': '16.62', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '-2.8', 'spread': '15.69', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '2.56', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '15.38', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '8.26', 'groupId': 'OG001'}, {'value': '-3.9', 'spread': '9.36', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '6.01', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '22.23', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '8.96', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '15.66', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '9.25', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.0', 'spread': '23.39', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '11.58', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '11.50', 'groupId': 'OG002'}, {'value': '6.5', 'spread': '11.33', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.7', 'spread': '21.13', 'groupId': 'OG000'}, {'value': '-16.5', 'spread': '23.33', 'groupId': 'OG001'}, {'value': '3.0', 'spread': '21.25', 'groupId': 'OG002'}, {'value': '8.4', 'spread': '8.02', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.5', 'spread': '13.44', 'groupId': 'OG001'}, {'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '19.80', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-23.0', 'spread': '26.87', 'groupId': 'OG000'}, {'value': '-11.5', 'spread': '17.68', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '8.8', 'spread': '12.04', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '11.31', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '4.24', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '13.75', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '5.66', 'groupId': 'OG001'}, {'value': '4.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '9.24', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '25.16', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '26.46', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '26.87', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '17.68', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '10.40', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '9.90', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '11.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '-17.7', 'spread': '16.0', 'groupId': 'OG002'}, {'value': '5.8', 'spread': '14.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '-14.8', 'spread': '16.8', 'groupId': 'OG002'}, {'value': '5.9', 'spread': '10.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '20.1', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '-10.5', 'spread': '16.1', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '7.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '8.2', 'groupId': 'OG001'}, {'value': '-10.4', 'spread': '14.9', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '10.4', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '23.5', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '3.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '-4.9', 'spread': '13.5', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '8.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '22.5', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '11.0', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-11.4', 'spread': '13.5', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '18.1', 'groupId': 'OG002'}, {'value': '8.0', 'spread': '13.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.5', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '-19.6', 'spread': '27.8', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '30.3', 'groupId': 'OG002'}, {'value': '10.6', 'spread': '9.5', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.9', 'spread': '15.7', 'groupId': 'OG001'}, {'value': '2.9', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '7.6', 'spread': '22.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-19.4', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '-13.6', 'spread': '21.2', 'groupId': 'OG001'}, {'value': '-2.5', 'spread': '3.6', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '13.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '5.5', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '15.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '5.8', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '10.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '29.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '11.5', 'spread': '30.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.0', 'spread': '30.0', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '26.1', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '7.1', 'spread': '13.9', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '12.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '11.48', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '5.90', 'groupId': 'OG001'}, {'value': '-9.1', 'spread': '16.06', 'groupId': 'OG002'}, {'value': '7.0', 'spread': '14.88', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '16.80', 'groupId': 'OG000'}, {'value': '-4.8', 'spread': '4.35', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '4.93', 'groupId': 'OG002'}, {'value': '1.1', 'spread': '4.62', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '11.99', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '5.57', 'groupId': 'OG001'}, {'value': '-4.1', 'spread': '9.65', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '8.47', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '31.24', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '9.29', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '16.88', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '7.69', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.5', 'spread': '23.67', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '4.16', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '10.17', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '10.48', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '36.39', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '11.13', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '27.79', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '6.64', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-16.0', 'spread': '13.22', 'groupId': 'OG000'}, {'value': '-13.0', 'spread': '14.14', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '19.04', 'groupId': 'OG002'}, {'value': '9.3', 'spread': '22.13', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-20.3', 'spread': '28.36', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '15.48', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '11.04', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '10.19', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-17.0', 'spread': '29.51', 'groupId': 'OG000'}, {'value': '-19.0', 'spread': '25.46', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '7.81', 'groupId': 'OG002'}, {'value': '7.2', 'spread': '4.97', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-25.5', 'spread': '14.85', 'groupId': 'OG001'}, {'value': '5.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-25.0', 'spread': '28.28', 'groupId': 'OG000'}, {'value': '-24.5', 'spread': '21.92', 'groupId': 'OG001'}, {'value': '6.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '-2.3', 'spread': '14.29', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-21.5', 'spread': '9.19', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '10.41', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-50.4', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '8.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '1.7', 'spread': '9.61', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '7.55', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '11.59', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '4.24', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '4.24', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.5', 'spread': '45.68', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '-19.5', 'spread': '27.58', 'groupId': 'OG002'}, {'value': '0.6', 'spread': '5.59', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124,136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '-9.7', 'spread': '12.7', 'groupId': 'OG001'}, {'value': '-14.8', 'spread': '18.5', 'groupId': 'OG002'}, {'value': '13.9', 'spread': '31.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '32.2', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '-13.2', 'spread': '13.6', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '15.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '-12.0', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '22.2', 'groupId': 'OG002'}, {'value': '6.8', 'spread': '21.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.4', 'spread': '52.4', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '31.6', 'groupId': 'OG002'}, {'value': '7.4', 'spread': '14.4', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.9', 'spread': '36.3', 'groupId': 'OG000'}, {'value': '-13.3', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '-10.4', 'spread': '30.9', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '17.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.7', 'spread': '69.5', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '25.1', 'groupId': 'OG001'}, {'value': '6.2', 'spread': '35.2', 'groupId': 'OG002'}, {'value': '5.1', 'spread': '15.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-23.0', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '-22.8', 'spread': '17.8', 'groupId': 'OG001'}, {'value': '20.7', 'spread': '69.3', 'groupId': 'OG002'}, {'value': '13.1', 'spread': '24.9', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.7', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-22.2', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '-23.1', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '38.4', 'groupId': 'OG002'}, {'value': '9.5', 'spread': '13.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.7', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '-26.8', 'spread': '34.7', 'groupId': 'OG001'}, {'value': '15.6', 'spread': '39.5', 'groupId': 'OG002'}, {'value': '17.9', 'spread': '15.1', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-42.0', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '25.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '11.9', 'spread': '2.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-23.4', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '-38.0', 'spread': '24.8', 'groupId': 'OG001'}, {'value': '33.8', 'spread': '22.9', 'groupId': 'OG002'}, {'value': '6.1', 'spread': '24.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-36.5', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '28.4', 'spread': '23.5', 'groupId': 'OG002'}, {'value': '16.0', 'spread': '32.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-50.4', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '40.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '8.1', 'spread': '28.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '18.0', 'spread': '23.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '2.9', 'spread': '33.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '14.1', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '32.1', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '39.2', 'spread': '78.5', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-17.1', 'spread': '24.2', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '18.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.079', 'spread': '0.146', 'groupId': 'OG000'}, {'value': '0.098', 'spread': '0.369', 'groupId': 'OG001'}, {'value': '-0.051', 'spread': '0.241', 'groupId': 'OG002'}, {'value': '-0.004', 'spread': '0.208', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.060', 'spread': '0.075', 'groupId': 'OG000'}, {'value': '0.163', 'spread': '0.456', 'groupId': 'OG001'}, {'value': '-0.040', 'spread': '0.182', 'groupId': 'OG002'}, {'value': '-0.118', 'spread': '0.105', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.109', 'spread': '0.149', 'groupId': 'OG000'}, {'value': '0.171', 'spread': '0.470', 'groupId': 'OG001'}, {'value': '0.053', 'spread': '0.230', 'groupId': 'OG002'}, {'value': '0.012', 'spread': '0.272', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.083', 'spread': '0.115', 'groupId': 'OG000'}, {'value': '0.164', 'spread': '0.437', 'groupId': 'OG001'}, {'value': '0.017', 'spread': '0.092', 'groupId': 'OG002'}, {'value': '0.062', 'spread': '0.434', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.043', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-0.070', 'spread': '0.594', 'groupId': 'OG001'}, {'value': '0.098', 'spread': '0.252', 'groupId': 'OG002'}, {'value': '-0.085', 'spread': '0.178', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.023', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '0.129', 'spread': '0.362', 'groupId': 'OG001'}, {'value': '0.086', 'spread': '0.165', 'groupId': 'OG002'}, {'value': '0.099', 'spread': '0.230', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.020', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '0.188', 'spread': '0.235', 'groupId': 'OG001'}, {'value': '0.006', 'spread': '0.208', 'groupId': 'OG002'}, {'value': '-0.086', 'spread': '0.188', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.420', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.110', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '0.248', 'spread': '0.357', 'groupId': 'OG001'}, {'value': '-0.043', 'spread': '0.206', 'groupId': 'OG002'}, {'value': '-0.018', 'spread': '0.198', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.247', 'spread': '0.375', 'groupId': 'OG000'}, {'value': '0.105', 'spread': '0.035', 'groupId': 'OG001'}, {'value': '0.002', 'spread': '0.131', 'groupId': 'OG002'}, {'value': '-0.050', 'spread': '0.131', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.020', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '0.170', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.065', 'spread': '0.035', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.040', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-0.055', 'spread': '0.106', 'groupId': 'OG001'}, {'value': '0.090', 'spread': '0.042', 'groupId': 'OG002'}, {'value': '0.003', 'spread': '0.203', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.020', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-0.010', 'spread': '0.269', 'groupId': 'OG001'}, {'value': '0.100', 'spread': '0.141', 'groupId': 'OG002'}, {'value': '-0.060', 'spread': '0.249', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.190', 'spread': '0.071', 'groupId': 'OG001'}, {'value': '0.130', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-0.037', 'spread': '0.085', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.100', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.003', 'spread': '0.185', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.070', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-0.087', 'spread': '0.199', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.090', 'spread': '0.028', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': '0.014', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.170', 'spread': '0.123', 'groupId': 'OG000'}, {'value': '0.050', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '0.025', 'spread': '0.205', 'groupId': 'OG002'}, {'value': '0.154', 'spread': '0.082', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124,136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.2', 'spread': '38.5', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '41.7', 'groupId': 'OG001'}, {'value': '3.4', 'spread': '44.1', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '28.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.4', 'spread': '19.2', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '49.7', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '33.1', 'groupId': 'OG002'}, {'value': '-16.3', 'spread': '12.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.7', 'spread': '36.1', 'groupId': 'OG000'}, {'value': '27.8', 'spread': '51.4', 'groupId': 'OG001'}, {'value': '15.8', 'spread': '36.8', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '37.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.6', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '30.2', 'spread': '51.4', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '21.6', 'groupId': 'OG002'}, {'value': '7.8', 'spread': '46.4', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '27.8', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '68.2', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '52.2', 'groupId': 'OG002'}, {'value': '-10.9', 'spread': '29.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.3', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '27.5', 'spread': '48.8', 'groupId': 'OG001'}, {'value': '25.4', 'spread': '29.4', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '36.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '51.0', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '38.0', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '35.7', 'groupId': 'OG002'}, {'value': '-13.3', 'spread': '28.1', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-60.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.1', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '57.1', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '31.6', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '33.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.0', 'spread': '53.7', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '29.3', 'groupId': 'OG002'}, {'value': '-7.6', 'spread': '21.4', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '39.5', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '9.2', 'spread': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-11.9', 'spread': '25.2', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '0.4', 'spread': '31.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '35.1', 'groupId': 'OG001'}, {'value': '37.0', 'spread': '52.4', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '30.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-23.6', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '30.2', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-5.7', 'spread': '12.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.3', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '25.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '16.3', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-7.6', 'spread': '29.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.4', 'spread': '0.9', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.8', 'spread': '36.4', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '26.4', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '69.2', 'groupId': 'OG002'}, {'value': '26.8', 'spread': '16.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.095', 'groupId': 'OG001'}, {'value': '0.005', 'spread': '0.094', 'groupId': 'OG002'}, {'value': '0.010', 'spread': '0.061', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.055', 'spread': '0.157', 'groupId': 'OG001'}, {'value': '-0.030', 'spread': '0.081', 'groupId': 'OG002'}, {'value': '-0.028', 'spread': '0.041', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.029', 'spread': '0.055', 'groupId': 'OG000'}, {'value': '0.039', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '0.004', 'spread': '0.062', 'groupId': 'OG002'}, {'value': '0.008', 'spread': '0.073', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '0.045', 'spread': '0.160', 'groupId': 'OG001'}, {'value': '-0.005', 'spread': '0.063', 'groupId': 'OG002'}, {'value': '0.020', 'spread': '0.125', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.041', 'groupId': 'OG000'}, {'value': '-0.080', 'spread': '0.210', 'groupId': 'OG001'}, {'value': '0.007', 'spread': '0.087', 'groupId': 'OG002'}, {'value': '-0.038', 'spread': '0.065', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.024', 'spread': '0.080', 'groupId': 'OG000'}, {'value': '0.034', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '0.015', 'spread': '0.052', 'groupId': 'OG002'}, {'value': '0.031', 'spread': '0.058', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.008', 'spread': '0.081', 'groupId': 'OG000'}, {'value': '0.053', 'spread': '0.061', 'groupId': 'OG001'}, {'value': '-0.007', 'spread': '0.076', 'groupId': 'OG002'}, {'value': '-0.019', 'spread': '0.043', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-46.2', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.027', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.098', 'spread': '0.069', 'groupId': 'OG001'}, {'value': '-0.033', 'spread': '0.073', 'groupId': 'OG002'}, {'value': '0.027', 'spread': '0.057', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.114', 'groupId': 'OG000'}, {'value': '0.070', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '-0.007', 'spread': '0.043', 'groupId': 'OG002'}, {'value': '0.012', 'spread': '0.026', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.030', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}, {'value': '0.080', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.045', 'spread': '0.035', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.014', 'groupId': 'OG001'}, {'value': '0.050', 'spread': '0.028', 'groupId': 'OG002'}, {'value': '0.018', 'spread': '0.052', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.020', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.049', 'groupId': 'OG001'}, {'value': '0.055', 'spread': '0.035', 'groupId': 'OG002'}, {'value': '0.007', 'spread': '0.061', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.040', 'spread': '0.057', 'groupId': 'OG001'}, {'value': '0.070', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.020', 'spread': '0.035', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.030', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.013', 'spread': '0.046', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.050', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-0.003', 'spread': '0.090', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.015', 'spread': '0.007', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.007', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.028', 'groupId': 'OG001'}, {'value': '0.028', 'spread': '0.138', 'groupId': 'OG002'}, {'value': '0.053', 'spread': '0.044', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '31.2', 'groupId': 'OG001'}, {'value': '29.1', 'spread': '67.6', 'groupId': 'OG002'}, {'value': '15.1', 'spread': '58.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '50.9', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '33.0', 'groupId': 'OG002'}, {'value': '-8.8', 'spread': '17.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '37.3', 'groupId': 'OG001'}, {'value': '21.2', 'spread': '61.9', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '44.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '17.9', 'spread': '27.5', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '44.9', 'groupId': 'OG001'}, {'value': '15.5', 'spread': '47.6', 'groupId': 'OG002'}, {'value': '14.3', 'spread': '50.2', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '63.0', 'groupId': 'OG001'}, {'value': '19.3', 'spread': '48.7', 'groupId': 'OG002'}, {'value': '-11.9', 'spread': '23.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.1', 'spread': '34.3', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '35.1', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '47.0', 'groupId': 'OG002'}, {'value': '19.6', 'spread': '38.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '39.7', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '26.7', 'groupId': 'OG001'}, {'value': '8.2', 'spread': '37.3', 'groupId': 'OG002'}, {'value': '-8.6', 'spread': '16.7', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-46.2', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '20.2', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '30.0', 'groupId': 'OG002'}, {'value': '11.4', 'spread': '21.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '35.0', 'groupId': 'OG000'}, {'value': '24.9', 'spread': '14.0', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '30.3', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '12.1', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG001'}, {'value': '53.3', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '17.1', 'spread': '10.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '37.0', 'spread': '13.7', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '23.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '13.7', 'groupId': 'OG001'}, {'value': '46.4', 'spread': '37.3', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '22.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-10.0', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '46.7', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '7.7', 'spread': '13.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '7.2', 'spread': '18.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.3', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '38.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '4.6', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '3.4', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.3', 'spread': '45.6', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '96.1', 'spread': '185.5', 'groupId': 'OG002'}, {'value': '40.8', 'spread': '46.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.012', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '0.011', 'spread': '0.068', 'groupId': 'OG002'}, {'value': '0.055', 'spread': '0.180', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.047', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '-0.085', 'spread': '0.093', 'groupId': 'OG001'}, {'value': '-0.017', 'spread': '0.117', 'groupId': 'OG002'}, {'value': '0.036', 'spread': '0.104', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.054', 'spread': '0.148', 'groupId': 'OG000'}, {'value': '-0.059', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '-0.040', 'spread': '0.107', 'groupId': 'OG002'}, {'value': '-0.014', 'spread': '0.167', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.021', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-0.024', 'spread': '0.099', 'groupId': 'OG001'}, {'value': '-0.022', 'spread': '0.125', 'groupId': 'OG002'}, {'value': '0.034', 'spread': '0.143', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '-0.067', 'spread': '0.150', 'groupId': 'OG001'}, {'value': '-0.023', 'spread': '0.121', 'groupId': 'OG002'}, {'value': '0.022', 'spread': '0.048', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.094', 'spread': '0.139', 'groupId': 'OG000'}, {'value': '-0.053', 'spread': '0.057', 'groupId': 'OG001'}, {'value': '-0.034', 'spread': '0.076', 'groupId': 'OG002'}, {'value': '-0.002', 'spread': '0.076', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.089', 'groupId': 'OG000'}, {'value': '-0.100', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '-0.043', 'spread': '0.130', 'groupId': 'OG002'}, {'value': '0.012', 'spread': '0.055', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.040', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.033', 'spread': '0.049', 'groupId': 'OG000'}, {'value': '-0.110', 'spread': '0.130', 'groupId': 'OG001'}, {'value': '-0.065', 'spread': '0.136', 'groupId': 'OG002'}, {'value': '0.020', 'spread': '0.046', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.053', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '-0.225', 'spread': '0.177', 'groupId': 'OG001'}, {'value': '-0.004', 'spread': '0.083', 'groupId': 'OG002'}, {'value': '0.038', 'spread': '0.026', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.195', 'spread': '0.134', 'groupId': 'OG001'}, {'value': '0.090', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.045', 'spread': '0.078', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '-0.225', 'spread': '0.163', 'groupId': 'OG001'}, {'value': '-0.020', 'spread': '0.099', 'groupId': 'OG002'}, {'value': '0.063', 'spread': '0.045', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.050', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-0.240', 'spread': '0.184', 'groupId': 'OG001'}, {'value': '0.035', 'spread': '0.078', 'groupId': 'OG002'}, {'value': '0.047', 'spread': '0.083', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.175', 'spread': '0.247', 'groupId': 'OG001'}, {'value': '0.050', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.053', 'spread': '0.021', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.070', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.043', 'spread': '0.032', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.080', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '0.040', 'spread': '0.026', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.070', 'spread': '0.042', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.045', 'spread': '0.092', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.115', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-0.045', 'spread': '0.049', 'groupId': 'OG001'}, {'value': '-0.035', 'spread': '0.021', 'groupId': 'OG002'}, {'value': '-0.106', 'spread': '0.149', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '6.4', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '8.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 16 + 24 H', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '9.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '-3.3', 'spread': '9.1', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '8.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '7.8', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '11.3', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '13.0', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '13.3', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '10.3', 'groupId': 'OG002'}, {'value': '2.2', 'spread': '4.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-7.7', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '6.3', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '6.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '-8.4', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '11.4', 'groupId': 'OG002'}, {'value': '1.3', 'spread': '5.3', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-8.8', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '-5.3', 'spread': '11.8', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '4.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-17.9', 'spread': '12.5', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '8.0', 'groupId': 'OG002'}, {'value': '3.7', 'spread': '2.4', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.6', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '9.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '7.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-18.0', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '9.6', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '4.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.9', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-19.1', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '7.7', 'groupId': 'OG002'}, {'value': '4.7', 'spread': '8.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.4', 'spread': '18.9', 'groupId': 'OG001'}, {'value': '5.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '3.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '3.9', 'spread': '2.5', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '4.3', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '9.4', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.1', 'spread': '12.7', 'groupId': 'OG000'}, {'value': '-4.3', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '2.0', 'groupId': 'OG002'}, {'value': '-5.8', 'spread': '4.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Absolute Change in Serum Z-AAT Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-125.511', 'spread': '59.955', 'groupId': 'OG000'}, {'value': '-156.714', 'spread': '58.127', 'groupId': 'OG001'}, {'value': '-169.044', 'spread': '40.328', 'groupId': 'OG002'}, {'value': '16.929', 'spread': '37.723', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-146.267', 'spread': '68.511', 'groupId': 'OG000'}, {'value': '-178.413', 'spread': '58.821', 'groupId': 'OG001'}, {'value': '-181.389', 'spread': '41.857', 'groupId': 'OG002'}, {'value': '-0.429', 'spread': '18.826', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-176.100', 'spread': '47.242', 'groupId': 'OG000'}, {'value': '-192.719', 'spread': '65.087', 'groupId': 'OG001'}, {'value': '-188.781', 'spread': '43.539', 'groupId': 'OG002'}, {'value': '7.000', 'spread': '26.712', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-158.650', 'spread': '50.266', 'groupId': 'OG000'}, {'value': '-185.213', 'spread': '58.059', 'groupId': 'OG001'}, {'value': '-182.240', 'spread': '45.710', 'groupId': 'OG002'}, {'value': '10.286', 'spread': '29.374', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-123.288', 'spread': '62.112', 'groupId': 'OG000'}, {'value': '-174.275', 'spread': '57.293', 'groupId': 'OG001'}, {'value': '-175.136', 'spread': '52.838', 'groupId': 'OG002'}, {'value': '-0.500', 'spread': '25.035', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-122.288', 'spread': '70.057', 'groupId': 'OG000'}, {'value': '-165.763', 'spread': '59.312', 'groupId': 'OG001'}, {'value': '-164.629', 'spread': '63.830', 'groupId': 'OG002'}, {'value': '1.429', 'spread': '20.137', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-189.850', 'spread': '64.556', 'groupId': 'OG000'}, {'value': '-150.900', 'spread': '17.521', 'groupId': 'OG001'}, {'value': '-194.535', 'spread': '51.128', 'groupId': 'OG002'}, {'value': '14.333', 'spread': '38.754', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-116.188', 'spread': '72.983', 'groupId': 'OG000'}, {'value': '-157.300', 'spread': '56.023', 'groupId': 'OG001'}, {'value': '-165.741', 'spread': '64.535', 'groupId': 'OG002'}, {'value': '-13.643', 'spread': '36.527', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-187.325', 'spread': '94.397', 'groupId': 'OG000'}, {'value': '-191.150', 'spread': '80.589', 'groupId': 'OG001'}, {'value': '-190.284', 'spread': '45.070', 'groupId': 'OG002'}, {'value': '0.333', 'spread': '27.208', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.00', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-164.067', 'spread': '65.875', 'groupId': 'OG000'}, {'value': '-189.225', 'spread': '91.259', 'groupId': 'OG001'}, {'value': '-177.060', 'spread': '49.718', 'groupId': 'OG002'}, {'value': '-9.500', 'spread': '20.907', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-142.767', 'spread': '89.632', 'groupId': 'OG000'}, {'value': '-260.200', 'spread': '82.166', 'groupId': 'OG001'}, {'value': '-186.116', 'spread': '44.539', 'groupId': 'OG002'}, {'value': '-1.800', 'spread': '28.490', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-271.100', 'spread': '90.793', 'groupId': 'OG001'}, {'value': '-194.160', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-35.000', 'spread': '15.556', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-204.650', 'spread': '18.597', 'groupId': 'OG000'}, {'value': '-244.100', 'spread': '91.358', 'groupId': 'OG001'}, {'value': '-187.650', 'spread': '3.323', 'groupId': 'OG002'}, {'value': '-60.725', 'spread': '84.824', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-233.000', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-263.100', 'spread': '91.358', 'groupId': 'OG001'}, {'value': '-182.550', 'spread': '3.182', 'groupId': 'OG002'}, {'value': '-22.333', 'spread': '22.679', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-237.650', 'spread': '102.743', 'groupId': 'OG001'}, {'value': '-183.000', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-26.000', 'spread': '22.271', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-183.300', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-8.000', 'spread': '22.650', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-89.1', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '9.333', 'spread': '11.719', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.500', 'spread': '9.192', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-192.240', 'spread': '81.657', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-42.750', 'spread': '7.089', 'groupId': 'OG000'}, {'value': '-103.533', 'spread': '3.443', 'groupId': 'OG001'}, {'value': '-39.000', 'spread': '1.414', 'groupId': 'OG002'}, {'value': '19.750', 'spread': '30.966', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 16, 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Serum Z-AAT Over Time Through EOS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-50.8', 'spread': '21.9', 'groupId': 'OG000'}, {'value': '-69.9', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '-85.5', 'spread': '4.8', 'groupId': 'OG002'}, {'value': '10.0', 'spread': '23.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-60.0', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '-82.2', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '-91.8', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '8.7', 'groupId': 'OG003'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-71.9', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '-88.4', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '-95.5', 'spread': '1.9', 'groupId': 'OG002'}, {'value': '3.4', 'spread': '11.4', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-62.4', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '-85.7', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '-91.9', 'spread': '5.8', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '12.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-48.2', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '-80.6', 'spread': '7.9', 'groupId': 'OG001'}, {'value': '-87.6', 'spread': '10.4', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '11.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-48.3', 'spread': '23.4', 'groupId': 'OG000'}, {'value': '-76.5', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '-81.3', 'spread': '18.8', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '9.2', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-73.9', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '-89.2', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '-93.9', 'spread': '5.0', 'groupId': 'OG002'}, {'value': '8.7', 'spread': '19.0', 'groupId': 'OG003'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-45.9', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '-73.0', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '-82.1', 'spread': '20.5', 'groupId': 'OG002'}, {'value': '-5.3', 'spread': '14.9', 'groupId': 'OG003'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-70.1', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '-77.6', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '-92.2', 'spread': '5.7', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '12.3', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG003'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-71.8', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '-75.1', 'spread': '9.0', 'groupId': 'OG001'}, {'value': '-88.8', 'spread': '10.1', 'groupId': 'OG002'}, {'value': '-2.4', 'spread': '9.3', 'groupId': 'OG003'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-60.1', 'spread': '32.6', 'groupId': 'OG000'}, {'value': '-77.8', 'spread': '7.2', 'groupId': 'OG001'}, {'value': '-90.3', 'spread': '6.3', 'groupId': 'OG002'}, {'value': '0.5', 'spread': '11.4', 'groupId': 'OG003'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-80.9', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '-95.6', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-11.7', 'spread': '4.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-82.5', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '-72.5', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '-93.8', 'spread': '0.3', 'groupId': 'OG002'}, {'value': '-21.3', 'spread': '29.6', 'groupId': 'OG003'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-91.7', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG000'}, {'value': '-78.4', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '-91.3', 'spread': '3.5', 'groupId': 'OG002'}, {'value': '-8.4', 'spread': '9.2', 'groupId': 'OG003'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-70.1', 'spread': '15.2', 'groupId': 'OG001'}, {'value': '-90.1', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-9.9', 'spread': '9.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-90.3', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '-3.2', 'spread': '8.8', 'groupId': 'OG003'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-89.1', 'spread': 'NA', 'comment': '1 participant analyzed', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '4.1', 'groupId': 'OG003'}]}]}, {'title': 'Week 160', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '2.9', 'groupId': 'OG003'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-91.7', 'spread': '8.5', 'groupId': 'OG002'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-18.0', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-53.8', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '-23.4', 'spread': '0.1', 'groupId': 'OG002'}, {'value': '9.1', 'spread': '12.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 16, 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: All randomized participants who received at least one dose of study drug; participants with an assessment at given time point.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg: Participants With No Fibrosis', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.'}, {'id': 'OG001', 'title': 'Fazirsiran 25 mg: Participants With Fibrosis', 'description': 'Participants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 100 mg: Participants With No Fibrosis', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.'}, {'id': 'OG003', 'title': 'Fazirsiran 100 mg: Participants With Fibrosis', 'description': 'Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG004', 'title': 'Fazirsiran 200 mg: Participants With No Fibrosis', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.'}, {'id': 'OG005', 'title': 'Fazirsiran 200 mg: Participants With Fibrosis', 'description': 'Participants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Day 1, Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}, {'value': '0', 'spread': '0', 'groupId': 'OG004'}, {'value': '0', 'spread': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 1, 1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '29.9', 'spread': '75.6', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '66.8', 'groupId': 'OG001'}, {'value': '190.0', 'spread': '17.9', 'groupId': 'OG002'}, {'value': '173.0', 'spread': '25.7', 'groupId': 'OG003'}, {'value': '495.0', 'spread': '71.8', 'groupId': 'OG004'}, {'value': '356.0', 'spread': '75.9', 'groupId': 'OG005'}]}]}, {'title': 'Day 1, 2h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '35.0', 'spread': '83.0', 'groupId': 'OG000'}, {'value': '60.7', 'spread': '72.5', 'groupId': 'OG001'}, {'value': '208.0', 'spread': '11.6', 'groupId': 'OG002'}, {'value': '199.0', 'spread': '32.2', 'groupId': 'OG003'}, {'value': '537.0', 'spread': '81.9', 'groupId': 'OG004'}, {'value': '471.0', 'spread': '56.5', 'groupId': 'OG005'}]}]}, {'title': 'Day 1, 24h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9.92', 'spread': '99.6', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '176.0', 'groupId': 'OG001'}, {'value': '69.0', 'spread': '88.4', 'groupId': 'OG002'}, {'value': '26.6', 'spread': '59.1', 'groupId': 'OG003'}, {'value': '11.7', 'spread': '17100', 'groupId': 'OG004'}, {'value': '27.7', 'spread': '612.0', 'groupId': 'OG005'}]}]}, {'title': 'Week 16, Pre-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}, {'value': '0', 'spread': '0', 'groupId': 'OG004'}, {'value': '0', 'spread': '0', 'groupId': 'OG005'}]}]}, {'title': 'Week 16, 1h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '38.1', 'spread': '75.3', 'groupId': 'OG001'}, {'value': '38.1', 'spread': '75.3', 'groupId': 'OG003'}, {'value': '396.0', 'spread': '64.9', 'groupId': 'OG005'}]}]}, {'title': 'Week 16, 2h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '45.1', 'spread': '70.1', 'groupId': 'OG001'}, {'value': '45.1', 'spread': '70.1', 'groupId': 'OG003'}, {'value': '487.0', 'spread': '62.5', 'groupId': 'OG005'}]}]}, {'title': 'Week 16, 24h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3.64', 'spread': '123.0', 'groupId': 'OG001'}, {'value': '3.64', 'spread': '123.0', 'groupId': 'OG003'}, {'value': '104.0', 'spread': '26.2', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Fazirsiran participants without fibrosis: Pre-dose, 1 hour, 2 hour, 24 hours post-dose on Day 1 (+/- 1 day). Fazirsiran participants with fibrosis: Pre-dose, 1 hour, 2 hours, 24 hours post-dose on Day 1 and Week 16 (+/- 1 day).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population: all Full Analysis Set participants who have at least 1 measurable plasma concentration data; participants with an assessment at given time point. Data not collected Week 16 for participants with no fibrosis per protocol.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'PDLB at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 88', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'PDLB at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 136', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Early Termination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 4, 16, 28, 40, 48, 52, 64, 76, 88, 96, 100, 112, 124, 136, 148 or Early Termination (up to 148 weeks)', 'description': 'PDLB=post-dose liver biopsy', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received at least one dose of fazirsiran; participants with an assessment at given time point'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Shifts From Baseline in METAVIR Fibrosis Stage at Post-Dose Biopsy for Participants With Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}], 'classes': [{'title': '>= 1-point improvement from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}, {'value': '50.0', 'groupId': 'OG002'}, {'value': '37.5', 'groupId': 'OG003'}]}]}, {'title': 'no change from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '44.4', 'groupId': 'OG003'}]}]}, {'title': '>= 1-point worsening from baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '42.9', 'groupId': 'OG002'}, {'value': '22.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Post-dose at Weeks 48 (+/- 2 weeks) or Week 72 (+/- 4 weeks) or Week 96 (+/- 4 weeks)', 'description': 'The METAVIR scoring system is a system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy. The stage represents the amount of fibrosis or scarring: 0= no fibrosis; 1=portal fibrosis without septa; 2=portal fibrosis with few septa; 3=numerous septa without cirrhosis; 4=cirrhosis. A higher score indicates a worse condition.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Biopsy Analysis Set: All randomized participants who received at least one dose of study drug and had at least one central read histology biopsy result; participants eligible to meet the defined criteria. (For example, participants with baseline METAVIR fibrosis score 0 are not eligible for improvement; participants with baseline METAVIR fibrosis score 4 are not eligible for worsening.)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'FG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'FG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'FG004', 'title': 'Fazirsiran 25 mg DB/200 mg OL', 'description': 'Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 25 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.'}, {'id': 'FG005', 'title': 'Fazirsiran 100 mg DB/200 mg OL', 'description': 'Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 100 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.'}, {'id': 'FG006', 'title': 'Fazirsiran 200 mg DB/200 mg OL', 'description': 'Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 200 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.'}, {'id': 'FG007', 'title': 'Placebo DB / Fazirsiran 200 mg OL', 'description': 'Participants with fibrosis at Screening who received double-blind (DB) placebo and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.'}], 'periods': [{'title': 'Double-Blind (DB) Period: Weeks 0 to 48', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}, {'title': 'Open-Label (OL) Period: Weeks 48 to 196', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Randomization was performed within each dose cohort to maintain blinding due to different dose volumes in the double-blinded phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Fazirsiran 25 mg', 'description': 'Participants with no fibrosis: Fazirsiran 25 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 25 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'BG001', 'title': 'Fazirsiran 100 mg', 'description': 'Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'BG002', 'title': 'Fazirsiran 200 mg', 'description': 'Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants with no fibrosis: Placebo administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '15.56', 'groupId': 'BG000'}, {'value': '47.9', 'spread': '12.25', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '9.44', 'groupId': 'BG002'}, {'value': '57.4', 'spread': '9.05', 'groupId': 'BG003'}, {'value': '53.1', 'spread': '12.33', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fibrosis Status at Screening', 'classes': [{'title': 'Fibrosis at Screening', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'No fibrosis at Screening', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-29', 'size': 1990642, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-18T14:01', 'hasProtocol': True}, {'date': '2024-01-30', 'size': 1034546, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-18T13:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2022-10-28', 'completionDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-30', 'studyFirstSubmitDate': '2019-05-08', 'resultsFirstSubmitDate': '2024-10-18', 'studyFirstSubmitQcDate': '2019-05-08', 'dispFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-12-06', 'studyFirstPostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Serum Z-Alpha-1 Antitrypsin (Z-AAT) at Week 16', 'timeFrame': 'Baseline, Week 16 (+/- 2 weeks)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Phase', 'timeFrame': 'Double Blind Phase (up to Week 48): dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.', 'description': 'An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. TEAEs/TESAEs are defined as those AEs that first occurred or worsened in severity following dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Phase', 'timeFrame': 'From dose administration of the first dose of open-label phase fazirsiran through EOS or Early Termination (up to Week 196).', 'description': 'An adverse event (AE) is any untoward medical occurrence, which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is an AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event or reaction. TEAEs/TESAEs are defined as those AEs that first occurred or worsened in severity following dose administration through end of study (EOS) or Early Termination or first dose of open-label phase fazirsiran.'}, {'measure': 'Absolute Change From Baseline in Total Liver Z-AAT (Insoluble + Soluble) Protein at Post-dose Biopsy for Participants With Fibrosis', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.'}, {'measure': 'Percent Change From Baseline in Total Liver Z-AAT (Insoluble + Soluble) Protein at Post-dose Biopsy for Participants With Fibrosis', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.'}, {'measure': 'Absolute Change From Baseline in Liver Z-AAT Soluble Protein at Post-dose Biopsy for Participants With Fibrosis', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.'}, {'measure': 'Percent Change From Baseline in Liver Z-AAT Soluble Protein at Post-dose Biopsy for Participants With Fibrosis', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.'}, {'measure': 'Absolute Change From Baseline in Liver Z-AAT Insoluble Protein at Post-dose Biopsy for Participants With Fibrosis', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.'}, {'measure': 'Percent Change From Baseline in Liver Z-AAT Insoluble Protein at Post-dose Biopsy for Participants With Fibrosis', 'timeFrame': 'Baseline, Week 48 (+/- 2 weeks), or Week 72 (+/- 4 weeks), or Week 96 (+/- 4 weeks)', 'description': 'Post-dose biopsy includes all post-dose biopsy collected at Week 48 or Week 72 or Week 96.'}, {'measure': 'Absolute Change From Baseline in Liver Function Tests: Alanine Aminotransferase (ALT) at Week 16 and Over Time Through End of Study (EOS)', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percent Change From Baseline in Liver Function Tests: ALT at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Absolute Change From Baseline in Liver Function Tests: Aspartate Aminotransferase (AST) at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percent Change From Baseline in Liver Function Tests: AST at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Absolute Change From Baseline in Liver Function Tests: Alkaline Phosphatase (ALP) at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percent Change From Baseline in Liver Function Tests: ALP at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Absolute Change From Baseline in Liver Function Tests: Gamma Glutamyl Transferase (GGT) at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124,136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percent Change From Baseline in Liver Function Tests: GGT at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Absolute Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124,136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percent Change From Baseline in Liver Function Tests: Total Bilirubin at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Absolute Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percent Change From Baseline in Liver Function Tests: Direct Bilirubin at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Absolute Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percent Change From Baseline in Liver Function Tests: Prothrombin International Normalized Ratio at Week 16 and Over Time Through EOS', 'timeFrame': 'Baseline, Week 16, Week 16 + 24 hours (H), Weeks 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Absolute Change in Serum Z-AAT Over Time Through EOS', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 16, 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percent Change in Serum Z-AAT Over Time Through EOS', 'timeFrame': 'Baseline, Weeks 2, 4, 6, 16, 28, 40, 48, 52, 64, 72, 76, 88, 96, 100, 112, 124, 136, 148, 160, Early Termination (up to 196 weeks), EOS (up to 208 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Pharmacokinetics (PK): ARO-AAT Plasma Concentration Summary for the Double-Blind Phase', 'timeFrame': 'Fazirsiran participants without fibrosis: Pre-dose, 1 hour, 2 hour, 24 hours post-dose on Day 1 (+/- 1 day). Fazirsiran participants with fibrosis: Pre-dose, 1 hour, 2 hours, 24 hours post-dose on Day 1 and Week 16 (+/- 1 day).'}, {'measure': 'Number of Participants Positive for Anti-Drug Antibodies to Fazirsiran', 'timeFrame': 'Baseline, Weeks 4, 16, 28, 40, 48, 52, 64, 76, 88, 96, 100, 112, 124, 136, 148 or Early Termination (up to 148 weeks)', 'description': 'PDLB=post-dose liver biopsy'}, {'measure': 'Percentage of Participants With Shifts From Baseline in METAVIR Fibrosis Stage at Post-Dose Biopsy for Participants With Fibrosis', 'timeFrame': 'Baseline, Post-dose at Weeks 48 (+/- 2 weeks) or Week 72 (+/- 4 weeks) or Week 96 (+/- 4 weeks)', 'description': 'The METAVIR scoring system is a system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy. The stage represents the amount of fibrosis or scarring: 0= no fibrosis; 1=portal fibrosis without septa; 2=portal fibrosis with few septa; 3=numerous septa without cirrhosis; 4=cirrhosis. A higher score indicates a worse condition.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alpha 1-Antitrypsin Deficiency']}, 'referencesModule': {'references': [{'pmid': '38964420', 'type': 'DERIVED', 'citation': 'Clark VC, Strange C, Strnad P, Sanchez AJ, Kwo P, Pereira VM, van Hoek B, Barjaktarevic I, Corsico AG, Pons M, Goldklang M, Gray M, Kuhn B, Vargas HE, Vierling JM, Vuppalanchi R, Brantly M, Kappe N, Chang T, Schluep T, Zhou R, Hamilton J, San Martin J, Loomba R. Fazirsiran for Adults With Alpha-1 Antitrypsin Deficiency Liver Disease: A Phase 2 Placebo Controlled Trial (SEQUOIA). Gastroenterology. 2024 Oct;167(5):1008-1018.e5. doi: 10.1053/j.gastro.2024.06.028. Epub 2024 Jul 2.'}, {'pmid': '34256305', 'type': 'DERIVED', 'citation': 'Remih K, Amzou S, Strnad P. Alpha1-antitrypsin deficiency: New therapies on the horizon. Curr Opin Pharmacol. 2021 Aug;59:149-156. doi: 10.1016/j.coph.2021.06.001. Epub 2021 Jul 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).', 'detailedDescription': 'Participants will be enrolled to receive multiple subcutaneous injections of Fazirsiran Injection (also referred to as TAK-999 Injection or ARO-AAT Injection) or placebo. Eligible participants will require a pre-dose biopsy completed as part of the study within the screening window. However, any participant with a biopsy result within 1 year of screening showing no fibrosis does not require a pre-dose biopsy. Only participants who have liver fibrosis will undergo a post-dose biopsy and may continue treatment in an open-label phase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of AATD\n* Liver biopsy at Screening indicating liver fibrosis (score less than F4); a patient with no fibrosis may participate based on a previous biopsy conducted within one year\n* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception\n* Willing to provide written informed consent and to comply with study requirements\n* Non-smoker for at least 1 year\n* No abnormal finding of clinical relevance at Screening\n\nExclusion Criteria:\n\n* Clinically significant health concerns other than AATD\n* Previous diagnosis or diagnosis at Screening of definitive liver cirrhosis\n* Previous lung or liver transplant due to AATD\n* Regular use of alcohol within one month prior to Screening\n* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study involving therapeutic intervention\n* Use of illicit drugs within 1 year prior to Screening\n\nNOTE: additional inclusion/exclusion criteria may apply, per protocol'}, 'identificationModule': {'nctId': 'NCT03945292', 'acronym': 'SEQUOIA', 'briefTitle': 'Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arrowhead Pharmaceuticals'}, 'officialTitle': 'A Placebo-Controlled, Multi-dose, Phase 2 Study to Determine the Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT) in Patients With Alpha-1 Antitrypsin Deficiency (AATD) [SEQUOIA]', 'orgStudyIdInfo': {'id': 'AROAAT2001'}, 'secondaryIdInfos': [{'id': '2018-003385-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fazirsiran 25 mg DB/200 mg OL', 'description': 'Double-blind (DB) Period: Participants with no fibrosis: Administered on Day 1 and Week 4. Participants with fibrosis: Administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.\n\nOpen-label (OL) Period: Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 25 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.', 'interventionNames': ['Drug: Fazisiran Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Fazirsiran 100 mg DB/200 mg OL', 'description': 'DB Period: Participants with no fibrosis: Fazirsiran 100 mg administered on Day 1 and Week 4. Participants with fibrosis: Fazirsiran 100 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.\n\nOL Period: Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 100 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.', 'interventionNames': ['Drug: Fazisiran Injection']}, {'type': 'EXPERIMENTAL', 'label': 'Fazirsiran 200 mg DB/200 mg OL', 'description': 'DB Period: Participants with no fibrosis: Fazirsiran 200 mg administered on Day 1 and Week 4.\n\nParticipants with fibrosis: Fazirsiran 200 mg administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.\n\nOL Period: Participants with fibrosis at Screening who received double-blind (DB) fazirsiran 200 mg and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study', 'interventionNames': ['Drug: Fazisiran Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo DB / Fazirsiran 200 mg OL', 'description': 'DB Period: Participants with no fibrosis: Placebo administered on Day 1 and Week 4. Participants with fibrosis: Placebo administered on Day 1, Week 4, and Week 16, then every 12 weeks up to 18 total doses.\n\nOL Period: Participants with fibrosis at Screening who received double-blind (DB) placebo and who completed the post-dose liver biopsy at Week 48 (or Week 72 or Week 96) entered the open-label phase and received fazirsiran 200 mg every 12 weeks for the duration of the study.', 'interventionNames': ['Drug: Fazisiran Injection', 'Other: Placebo']}], 'interventions': [{'name': 'Fazisiran Injection', 'type': 'DRUG', 'otherNames': ['ARO-AAT Injection', 'TAK-999 Injection'], 'description': 'solution for subcutaneous (sc) injection', 'armGroupLabels': ['Fazirsiran 100 mg DB/200 mg OL', 'Fazirsiran 200 mg DB/200 mg OL', 'Fazirsiran 25 mg DB/200 mg OL', 'Placebo DB / Fazirsiran 200 mg OL']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'sterile normal saline (0.9% NaCl), calculated to match active comparator, for sc injection', 'armGroupLabels': ['Placebo DB / Fazirsiran 200 mg OL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site 5', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site 9', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 14', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 17', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 11', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 15', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Research Site 13', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site 2', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Research Site 7', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site 3', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site 10', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site 12', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Site 1', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Site 4', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site 19', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Research Site 16', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Research Site 27', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Research Site 22', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Research Site 23', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '9004-514', 'city': 'Funchal', 'country': 'Portugal', 'facility': 'Research Site 24', 'geoPoint': {'lat': 32.66568, 'lon': -16.92547}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Research Site 20', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arrowhead Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}