Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-01-08 @ 12:45 AM
Study NCT ID:
NCT00618618
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2008-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}], 'ancestors': [{'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical_trials@kythera.com', 'title': 'Clinical Trial Disclosure', 'organization': 'Kythera'}, 'certainAgreement': {'otherDetails': 'The Clinical Study Agreement requires that the investigator or institution obtain written consent from Kythera prior to presenting and/or publishing results of this study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).', 'eventGroups': [{'id': 'EG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'otherNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'otherNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'otherNumAtRisk': 20, 'otherNumAffected': 20, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'otherNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Joint Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Faeces Pale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hair Growth Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Lower Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vaginal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinus Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Productive Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthropod Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Premenstrual Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Eye Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Vesicles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Injection Site Warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Streptococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Periorbital haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bile Duct Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': '0Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Adverse event associated with treatment area', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Study drug-related adverse event', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Study drug-related severe adverse event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Discontinued due to adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).', 'description': "The investigator determined the relationship of each adverse event to the administration of study drug.\n\nSeverity of adverse events was determined using the following scale:\n\n* Mild: The participant is aware of a sign or symptom, but it is easily tolerated\n* Moderate: Discomfort or interference with usual activity\n* Severe: Incapacitating, with inability to engage in usual activity.\n\nA serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:\n\n* was fatal\n* was life-threatening\n* required inpatient hospitalization or prolongation of existing hospitalization\n* resulted in persistent or significant disability/incapacity\n* was a congenital anomaly/birth defect\n* other significant medical hazard", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/miTT subset'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Submental Fat (SMF) Rating Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.50', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an analysis of covariance (ANCOVA) model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '-0.4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.069', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)', 'description': "The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.\n\nA negative change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Satisfaction With Appearance Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '1.34', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '2.20', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '1.72', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '0.6', 'ciUpperLimit': '3.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '1.0', 'ciUpperLimit': '4.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.122', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '2.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)', 'description': "The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.\n\nA positive change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Response in the Subject Global Improvement Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000'}, {'value': '90.0', 'groupId': 'OG001'}, {'value': '80.0', 'groupId': 'OG002'}, {'value': '57.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.3', 'ciLowerLimit': '11.0', 'ciUpperLimit': '65.7', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.172', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.9', 'ciLowerLimit': '1.0', 'ciUpperLimit': '64.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.252', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.9', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '54.2', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks after last treatment (up to 16 weeks after first dose)', 'description': 'Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.\n\n0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.\n\nResponse is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset with available data'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With an SMF Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}, {'value': '90.0', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}, {'value': '35.7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.1', 'ciLowerLimit': '16.3', 'ciUpperLimit': '75.9', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.3', 'ciLowerLimit': '23.0', 'ciUpperLimit': '85.5', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.296', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.3', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '57.3', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)', 'description': "Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Skin Laxity Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.78', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.57', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.66', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.39', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.53', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '-0.2', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '-0.1', 'spread': '0.53', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.55', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.460', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 4', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.906', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 4', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.404', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 4', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.791', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.3', 'groupDescription': 'Week 8', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.410', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.6', 'groupDescription': 'Week 8', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.733', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'groupDescription': 'Week 8', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.542', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'groupDescription': 'Week 12', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.882', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.5', 'groupDescription': 'Week 12', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.934', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 12', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.838', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 16', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.777', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 16', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.795', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.5', 'groupDescription': 'Week 16', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.852', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 24', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.444', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.3', 'groupDescription': 'Week 24', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.724', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'groupDescription': 'Week 24', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)', 'description': 'Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:\n\n1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '0.32', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '0.47', 'groupId': 'OG003'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.50', 'groupId': 'OG003'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.51', 'groupId': 'OG003'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.50', 'groupId': 'OG003'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.51', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.934', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 4', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.286', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 4', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.190', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.1', 'ciUpperLimit': '0.7', 'groupDescription': 'Week 4', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.402', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 8', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.290', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.2', 'groupDescription': 'Week 8', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.863', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 8', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.128', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 12', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.1', 'groupDescription': 'Week 12', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.489', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.3', 'groupDescription': 'Week 12', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.1', 'groupDescription': 'Week 16', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 16', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.122', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.1', 'groupDescription': 'Week 16', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 24', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 24', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.2', 'groupDescription': 'Week 24', 'statisticalMethod': 'Repeated Measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on repeated measures analysis of variance with treatment, visit, center, treatment x visit as fixed effects and subject as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)', 'description': "The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.\n\nA negative change from Baseline indicates improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'title': 'Laboratory Values', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Weight', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Vital Signs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Physical Examinations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Cervicomental Angle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'spread': '9.85', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '7.84', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '10.40', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '7.80', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.573', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-8.6', 'ciUpperLimit': '4.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.653', 'groupIds': ['OG001', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '9.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.688', 'groupIds': ['OG002', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '8.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on an ANCOVA model with treatment as the main effect and baseline SMF Rating Scale score as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)', 'description': 'The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset with available data'}, {'type': 'SECONDARY', 'title': 'Visual Analogue Scale Pain Intensity Rating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'OG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'classes': [{'title': 'Treatment 1 (N=24, 12, 20, 14)', 'categories': [{'measurements': [{'value': '33.0', 'spread': '27.29', 'groupId': 'OG000'}, {'value': '25.8', 'spread': '16.19', 'groupId': 'OG001'}, {'value': '41.9', 'spread': '27.50', 'groupId': 'OG002'}, {'value': '17.1', 'spread': '19.03', 'groupId': 'OG003'}]}]}, {'title': 'Treatment 2 (N=19, 10, 16, 14)', 'categories': [{'measurements': [{'value': '27.9', 'spread': '27.69', 'groupId': 'OG000'}, {'value': '38.2', 'spread': '26.62', 'groupId': 'OG001'}, {'value': '31.1', 'spread': '31.00', 'groupId': 'OG002'}, {'value': '24.9', 'spread': '28.73', 'groupId': 'OG003'}]}]}, {'title': 'Treatment 3 (N=17, 10, 16, 13)', 'categories': [{'measurements': [{'value': '26.5', 'spread': '28.50', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '25.35', 'groupId': 'OG001'}, {'value': '22.6', 'spread': '30.77', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '27.21', 'groupId': 'OG003'}]}]}, {'title': 'Treatment 4 (N=14, 10, 15, 14)', 'categories': [{'measurements': [{'value': '14.0', 'spread': '18.68', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '14.55', 'groupId': 'OG001'}, {'value': '19.0', 'spread': '24.74', 'groupId': 'OG002'}, {'value': '16.7', 'spread': '27.27', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12', 'description': 'Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety/mITT subset with available data at each time point (indicated by "N")'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'FG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'FG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'FG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Patient Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Inability to Complete Study Procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Did Not Meet Entry Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted at 7 study centers: 4 in Canada, 2 in Australia and 1 in the United Kingdom.', 'preAssignmentDetails': 'Participants were randomized to receive either deoxycholic acid or placebo injection in one of 3 treatment dosing regimens for a total of 6 treatment groups. Placebo participants were pooled for analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'BG001', 'title': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'BG002', 'title': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'BG003', 'title': 'Pooled Placebo', 'description': 'Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.5', 'spread': '7.79', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '4.23', 'groupId': 'BG001'}, {'value': '47.0', 'spread': '10.37', 'groupId': 'BG002'}, {'value': '49.4', 'spread': '10.85', 'groupId': 'BG003'}, {'value': '47.1', 'spread': '8.69', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.31', 'spread': '11.987', 'groupId': 'BG000'}, {'value': '82.10', 'spread': '18.204', 'groupId': 'BG001'}, {'value': '90.80', 'spread': '17.128', 'groupId': 'BG002'}, {'value': '84.78', 'spread': '16.381', 'groupId': 'BG003'}, {'value': '83.78', 'spread': '16.074', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Submental Fat (SMF) Rating', 'classes': [{'title': '2', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'SMF Ratings:\n\n* 0 = Absent submental convexity: No localized submental fat evident;\n* 1 = Mild submental convexity: Minimal, localized submental fat;\n* 2 = Moderate submental convexity: Prominent, localized submental fat;\n* 3 = Severe submental convexity: Marked, localized submental fat;\n* 4 = Extreme submental convexity.', 'unitOfMeasure': 'participants'}, {'title': 'Fitzpatrick Skin Type', 'classes': [{'title': 'I - III', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}]}, {'title': 'IV - VI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Fitzpatrick Skin Type is a numerical classification schema for human skin color and typical response to ultraviolet (UV) light:\n\n* Type I: Pale white skin, blue/hazel eyes, blond/red hair; Always burns, does not tan.\n* Type II: Fair skin, blue eyes; Burns easily, tans poorly.\n* Type III: Darker white skin; Tans after initial burn.\n* Type IV: Light brown skin; Burns minimally, tans easily.\n* Type V: Brown skin; Rarely burns, tans darkly easily.\n* Type VI: Dark brown or black skin; Never burns, always tans darkly.', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety/Modified Intent-to-Treat (mITT) subset included all randomized participants who received at least 1 dose of study material and who had at least 1 post-baseline observation'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'dispFirstSubmitDate': '2014-05-30', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-17', 'studyFirstSubmitDate': '2008-02-08', 'dispFirstSubmitQcDate': '2014-05-30', 'resultsFirstSubmitDate': '2015-05-28', 'studyFirstSubmitQcDate': '2008-02-08', 'dispFirstPostDateStruct': {'date': '2014-06-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-28', 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).', 'description': "The investigator determined the relationship of each adverse event to the administration of study drug.\n\nSeverity of adverse events was determined using the following scale:\n\n* Mild: The participant is aware of a sign or symptom, but it is easily tolerated\n* Moderate: Discomfort or interference with usual activity\n* Severe: Incapacitating, with inability to engage in usual activity.\n\nA serious AE (SAE) was defined as an event that may constitute a significant medical hazard or side-effect, regardless of the investigator or sponsor's opinion regarding relatedness to study material. Serious events included, but were not limited to, any event that:\n\n* was fatal\n* was life-threatening\n* required inpatient hospitalization or prolongation of existing hospitalization\n* resulted in persistent or significant disability/incapacity\n* was a congenital anomaly/birth defect\n* other significant medical hazard"}, {'measure': 'Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Weight, Vital Signs, and Physical Examinations', 'timeFrame': 'From the first dose of study drug until 12 weeks after the last dose (up to 24 weeks after first treatment).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Submental Fat (SMF) Rating Scale Score', 'timeFrame': 'Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)', 'description': "The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.\n\nA negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Subject Satisfaction With Appearance Rating Scale', 'timeFrame': 'Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)', 'description': "The Subject Satisfaction with Appearance Rating Scale assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.\n\nA positive change from Baseline indicates improvement."}, {'measure': 'Percentage of Participants With a Response in the Subject Global Improvement Rating', 'timeFrame': '4 weeks after last treatment (up to 16 weeks after first dose)', 'description': 'Participants were asked to rate their total improvement or worsening in the appearance and physical feeling of their chin and neck area since before they received study treatment, whether or not they believed it was due to study treatment or to any other cause.\n\n0 = Very much worse, 1 = Much worse, 2 = Minimally worse, 3 = No change, 4 = Minimally improved, 5 = Much improved, 6 = Very much improved.\n\nResponse is defined as any improvement, ie, a global improvement rating of 4, 5, or 6.'}, {'measure': 'Percentage of Participants With an SMF Response', 'timeFrame': 'Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)', 'description': "Response is defined as a participant with at least a 1-grade improvement in SMF Rating Scale score at Week 16 from Baseline. The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme."}, {'measure': 'Change From Baseline in Skin Laxity Rating', 'timeFrame': 'Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)', 'description': 'Skin laxity assessment was based on clinical evaluation and palpation of the submental area on the following scale:\n\n1 = no laxity; 2 = minimal laxity; 3 = moderate laxity; 4 = very lax. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline to Each Visit in Submental Fat (SMF) Rating Scale Score', 'timeFrame': 'Baseline and Week 4, Week 8, Week 12, Week 16 (4 weeks after last treatment) and Week 24 (12 weeks after last treatment)', 'description': "The SMF rating scale score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.\n\nA negative change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in the Cervicomental Angle', 'timeFrame': 'Baseline and 4 weeks after last treatment (up to 16 weeks after first dose)', 'description': 'The cervicomental angle was measured using a profile view photograph obtained at each visit. A goniometer was used to determine the angle. Cervicomental angle measurements less than 80 degrees are excluded, due to error in measurement.'}, {'measure': 'Visual Analogue Scale Pain Intensity Rating', 'timeFrame': 'Approximately 60 minutes after completion of each treatment session at Week 0, Week 4, Week 8 and Week 12', 'description': 'Participants rated pain associated with the submental area on a 100 mm horizontal axis ranging from 0 (no pain) to 100 (most severe pain possible)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Moderate or Severe Submental Fullness']}, 'descriptionModule': {'briefSummary': 'Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Submental fat that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the submental fat (SMF) rating scale\n* Good general health\n* Signed informed consent\n\nExclusion Criteria:\n\n* History of any treatment in the neck or chin area\n* Loose skin or prominent platysmal bands in the neck or chin area\n* Recent treatment with anticoagulants\n* Presence of clinically significant health problems'}, 'identificationModule': {'nctId': 'NCT00618618', 'briefTitle': 'Phase 2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kythera Biopharmaceuticals'}, 'officialTitle': 'Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area', 'orgStudyIdInfo': {'id': 'ATX-101-07-07'}, 'secondaryIdInfos': [{'id': '2007-006303-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'interventionNames': ['Drug: Deoxycholic Acid Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0.2 mL/0.7 cm', 'description': 'Participants received placebo administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'interventionNames': ['Drug: Deoxycholic Acid Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0.2 mL/1.0 cm', 'description': 'Participants received placebo administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Deoxycholic Acid Injection 0.4 mL/1.0 cm', 'description': 'Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'interventionNames': ['Drug: Deoxycholic Acid Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0.4 mL/1.0 cm', 'description': 'Participants received placebo administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Deoxycholic Acid Injection', 'type': 'DRUG', 'otherNames': ['ATX-101'], 'description': 'Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.', 'armGroupLabels': ['Deoxycholic Acid Injection 0.2 mL/0.7 cm', 'Deoxycholic Acid Injection 0.2 mL/1.0 cm', 'Deoxycholic Acid Injection 0.4 mL/1.0 cm']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo 0.2 mL/0.7 cm', 'Placebo 0.2 mL/1.0 cm', 'Placebo 0.4 mL/1.0 cm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3142', 'city': 'Toorak', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Investigational Site', 'geoPoint': {'lat': -37.84165, 'lon': 145.01438}}, {'zip': '2000', 'city': 'Sydney', 'country': 'Australia', 'facility': 'Investigational Site', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': 'L2E 7H1', 'city': 'Niagara Falls', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational Site', 'geoPoint': {'lat': 43.10012, 'lon': -79.06627}}, {'zip': 'L6J 7W5', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational Site', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'M4V 1R1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 3B4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M68HD', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Investigational Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Frederick Beddingfield, III, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kythera Biopharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kythera Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}