Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-25 @ 9:12 AM
Study NCT ID:
NCT02310568
Status:
TERMINATED
Last Update Posted:
2017-01-09
First Post:
2014-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
POC Study in Partially Responsive Generalized Anxiety Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}], 'ancestors': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630159', 'term': 'PF-06372865'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'All 34 centres who enrolled subjects were terminated due to internal sponsor portfolio prioritization. The decision to terminate the study was not due to any safety concern or change in the benefit:risk assessment of PF-06372865'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2.', 'otherNumAtRisk': 87, 'otherNumAffected': 27, 'seriousNumAtRisk': 87, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PF-06372865 2.5 mg', 'description': 'All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.', 'otherNumAtRisk': 37, 'otherNumAffected': 13, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-06372865 7.5 mg', 'description': 'All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.', 'otherNumAtRisk': 35, 'otherNumAffected': 16, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '26.7', 'spread': '4.27', 'groupId': 'OG001'}, {'value': '26.1', 'spread': '4.0', 'groupId': 'OG002'}, {'value': '26.2', 'spread': '6.91', 'groupId': 'OG003'}, {'value': '22.5', 'spread': '4.24', 'groupId': 'OG004'}, {'value': '22.5', 'spread': '4.63', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) with less than (\\<) 50% reduction in HAM-A during Stage 1 baseline,Week 4 and HAM-A value of greater than or equal to (\\>=)16 at Week 4.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.5', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '1.54', 'groupId': 'OG001'}, {'value': '-9.9', 'spread': '1.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.784', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '3.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.01', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.184', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.6', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '5.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.94', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.360', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.0', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.22', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for Stage 1 included all randomized participants who had received at least 1 dose of randomized treatment. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'spread': '8.03', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '9.49', 'groupId': 'OG001'}, {'value': '16.5', 'spread': '6.87', 'groupId': 'OG002'}, {'value': '21.7', 'spread': '9.44', 'groupId': 'OG003'}, {'value': '15.5', 'spread': '7.01', 'groupId': 'OG004'}, {'value': '19.4', 'spread': '8.44', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Stage 1: Week 4, Stage 2: Week 8', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'title': 'Week 5 (n = 6, 8, 8)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.77', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '1.49', 'groupId': 'OG002'}]}]}, {'title': 'Week 6 (n = 6, 8, 8)', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '2.25', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.89', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '1.89', 'groupId': 'OG002'}]}]}, {'title': 'Week 7 (n = 6, 8, 7)', 'categories': [{'measurements': [{'value': '-4.6', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '1.74', 'groupId': 'OG002'}]}]}, {'title': 'Week 8 (n = 6, 8, 7)', 'categories': [{'measurements': [{'value': '-4.1', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '2.46', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '2.54', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.708', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '5.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.36', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.646', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.1', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '3.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.36', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.352', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '5.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.09', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.495', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.1', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '7.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.99', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.5', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '7.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.99', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.889', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-5.0', 'ciUpperLimit': '4.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.65', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.324', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '90', 'paramValue': '2.7', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '7.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.71', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.939', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '4.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.69', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.308', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.5', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '6.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.42', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.846', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8', 'ciLowerLimit': '-6.0', 'ciUpperLimit': '7.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.92', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.449', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.0', 'ciLowerLimit': '-9.8', 'ciUpperLimit': '3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.89', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.295', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.8', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '9.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.51', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 5, 6, 7, 8', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Stage 2 placebo non-responder set: Subset of Stage 2 placebo set (participants who received placebo in Stage 1) \\< 50 % reduction in HAM-A during Stage 1 baseline, Week 4 and HAM-A value of \\>=16 at Week 4. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'title': 'Total Score (n=45,24,21,6,8,8)', 'categories': [{'measurements': [{'value': '18.6', 'spread': '5.80', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '5.73', 'groupId': 'OG001'}, {'value': '17.0', 'spread': '5.55', 'groupId': 'OG002'}, {'value': '23.0', 'spread': '2.76', 'groupId': 'OG003'}, {'value': '15.3', 'spread': '6.86', 'groupId': 'OG004'}, {'value': '17.4', 'spread': '4.89', 'groupId': 'OG005'}]}]}, {'title': 'Social Subscale Score (n=45,24,21,6,8,8)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '1.88', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '1.80', 'groupId': 'OG002'}, {'value': '7.8', 'spread': '1.17', 'groupId': 'OG003'}, {'value': '5.0', 'spread': '2.56', 'groupId': 'OG004'}, {'value': '5.5', 'spread': '1.20', 'groupId': 'OG005'}]}]}, {'title': 'Work Subscale Score (n =37,19,16,6,6,7)', 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '3.06', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '2.28', 'groupId': 'OG002'}, {'value': '7.5', 'spread': '1.38', 'groupId': 'OG003'}, {'value': '5.3', 'spread': '2.58', 'groupId': 'OG004'}, {'value': '5.6', 'spread': '2.44', 'groupId': 'OG005'}]}]}, {'title': 'Family Subscale Score (n= 45,24,21,6,8,8)', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '2.23', 'groupId': 'OG002'}, {'value': '7.7', 'spread': '1.03', 'groupId': 'OG003'}, {'value': '5.3', 'spread': '2.49', 'groupId': 'OG004'}, {'value': '6.3', 'spread': '2.60', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)', 'description': 'SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'title': 'Total Score (n= 40,22,20,6,8,7)', 'categories': [{'measurements': [{'value': '-3.5', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '-4.7', 'spread': '1.40', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '2.90', 'groupId': 'OG003'}, {'value': '-5.9', 'spread': '2.36', 'groupId': 'OG004'}, {'value': '-2.4', 'spread': '2.40', 'groupId': 'OG005'}]}]}, {'title': 'Social Sub-scale Score (n= 40,22,20,6,8,7)', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '1.32', 'groupId': 'OG003'}, {'value': '-2.3', 'spread': '1.03', 'groupId': 'OG004'}, {'value': '-0.6', 'spread': '1.07', 'groupId': 'OG005'}]}]}, {'title': 'Work Sub-scale Score (n= 30,16,14,6,5,6)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.56', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.60', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '0.96', 'groupId': 'OG003'}, {'value': '-2.6', 'spread': '1.01', 'groupId': 'OG004'}, {'value': '-1.4', 'spread': '0.93', 'groupId': 'OG005'}]}]}, {'title': 'Family Sub-scale Score 9 (n= 40, 22, 20,6,8,7)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '-1.4', 'spread': '0.92', 'groupId': 'OG003'}, {'value': '-1.9', 'spread': '0.78', 'groupId': 'OG004'}, {'value': '-1.0', 'spread': '0.80', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.514', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.1', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.72', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.302', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.7', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.65', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.736', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '3.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.94', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.775', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '7.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.85', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.553', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.4', 'ciLowerLimit': '-9.4', 'ciUpperLimit': '4.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.00', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Total Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.299', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.5', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '9.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.30', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.994', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.65', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.870', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.885', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.74', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.834', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '2.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.78', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.281', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.0', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.80', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.272', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '4.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.43', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.249', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.8', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.7', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.285', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.285', 'paramValue': '0.9', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.82', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.635', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.7', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score ( Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.217', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.9', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.43', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.399', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '3.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.36', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.429', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.5', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.7', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.799', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 4): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.738', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '2.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.22', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.691', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.26', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '-0.5', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.417', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.11', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Week 8): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.998', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.11', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.353', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.1', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.16', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.296', 'groupIds': ['OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '5.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.92', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Total Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.841', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.95', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.332', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.0', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.95', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.359', 'groupIds': ['OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.81', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Social Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.347', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.8', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.78', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.8', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.80', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.212', 'groupIds': ['OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.79', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Work Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.954', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.69', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.407', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.6', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.70', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.412', 'groupIds': ['OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Family Sub-Scale Score (Combined Stage 1 and Stage 2): The ANCOVA model included change from baseline as dependent variable, and treatment and baseline in the model. Baseline for Stage 1 is Day 1 and baseline for Stage 2 is Week 4 (Day 28). The estimates from Stage 1 and the Stage 2 were combined together using a weighted mean (weight=0.5) and assuming the covariance between the two treatment effect estimates is zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Stage 1: Week 4, Stage 2: Week 8', 'description': 'SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}], 'classes': [{'title': 'Week 1 (n= 41,24,21)', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n= 39,23,21)', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '-7.7', 'spread': '1.45', 'groupId': 'OG002'}]}]}, {'title': 'Week 3 (n= 39,22,21)', 'categories': [{'measurements': [{'value': '-10.2', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '-9.2', 'spread': '1.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.856', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '2.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.45', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.647', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.817', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.60', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.670', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.8', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.81', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.736', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '3.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.74', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.496', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.4', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.99', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.575', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '3.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.72', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.362', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.5', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '4.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.67', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.771', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.6', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '2.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.90', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 1, 2, 3', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}, {'value': '25.00', 'groupId': 'OG001'}, {'value': '28.57', 'groupId': 'OG002'}, {'value': '16.67', 'groupId': 'OG003'}, {'value': '25.00', 'groupId': 'OG004'}, {'value': '12.50', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.75', 'ciLowerLimit': '0.45', 'ciUpperLimit': '1.26', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.60', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.54', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.26', 'ciLowerLimit': '0.69', 'ciUpperLimit': '2.32', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 1: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.24', 'ciLowerLimit': '0.27', 'ciUpperLimit': '5.78', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.13', 'ciLowerLimit': '0.19', 'ciUpperLimit': '24.51', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.58', 'ciLowerLimit': '0.16', 'ciUpperLimit': '2.09', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Stage 2: Logistic regression model included treatment as fixed effect, and the baseline as covariate. Baseline for Stage 1 is Day 1 and for Stage 2 is Day 28.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Week 4, Stage 2: Week 8', 'description': 'A responder was defined as a participant with \\>= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'title': 'Baseline : S1, S2 (n=45,23,21,6,8,8)', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '0.36', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '3.3', 'spread': '0.71', 'groupId': 'OG004'}, {'value': '3.0', 'spread': '0.76', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W1, S2: W5 (n=41,23,21,6,8,8)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.04', 'groupId': 'OG001'}, {'value': '-0.5', 'spread': '0.87', 'groupId': 'OG002'}, {'value': '-0.2', 'spread': '0.98', 'groupId': 'OG003'}, {'value': '-0.5', 'spread': '1.20', 'groupId': 'OG004'}, {'value': '0.3', 'spread': '0.46', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W2, S2: W6 (n=39,22,21,6,8,8)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.11', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '1.22', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '1.16', 'groupId': 'OG004'}, {'value': '0.1', 'spread': '0.64', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W3, S2: W7 (n=39,21,21,6,8,7)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '1.03', 'groupId': 'OG003'}, {'value': '-0.8', 'spread': '1.16', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.58', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W4, S2: W8 (n=40,21,20,6,8,7)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '-1.1', 'spread': '1.05', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '1.38', 'groupId': 'OG003'}, {'value': '-1.0', 'spread': '1.20', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '0.76', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.801', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.416', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.634', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.470', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.775', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.848', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.433', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.796', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.624', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.844', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.743', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'LS Mean Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.356', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.5', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.180', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.589', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.873', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.667', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.48', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.548', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.567', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.45', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.208', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.858', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.329', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.7', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.272', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.946', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.407', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.436', 'groupIds': ['OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)', 'description': 'CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'title': 'Baseline: S1 and S2 (n=45,24,21,6,8,8)', 'categories': [{'measurements': [{'value': '4.8', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '1.05', 'groupId': 'OG003'}, {'value': '4.3', 'spread': '0.89', 'groupId': 'OG004'}, {'value': '4.0', 'spread': '0.76', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W1, S2: W5 (n=41,24,21,6,8,8)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '-0.7', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '1.10', 'groupId': 'OG003'}, {'value': '-0.1', 'spread': '0.99', 'groupId': 'OG004'}, {'value': '0.0', 'spread': '0.53', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W2, S2: W6 (n=39,23,21,6,8,8)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '1.64', 'groupId': 'OG003'}, {'value': '0.0', 'spread': '0.93', 'groupId': 'OG004'}, {'value': '-0.1', 'spread': '0.64', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W3, S2: W7 (n=39,22,21,6,8,7)', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.98', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '1.33', 'groupId': 'OG003'}, {'value': '-1.0', 'spread': '0.93', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '0.49', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W4, S2: W8 (n=40,22,20,6,8,7)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '1.08', 'groupId': 'OG002'}, {'value': '-0.5', 'spread': '1.87', 'groupId': 'OG003'}, {'value': '-1.1', 'spread': '0.83', 'groupId': 'OG004'}, {'value': '-0.6', 'spread': '0.79', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.21', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.996', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.20', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.377', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.291', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.925', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.390', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.502', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.160', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.5', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.965', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.389', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.433', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.940', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'LS Mean Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.757', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.836', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.827', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.507', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.632', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.442', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '1.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.51', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.643', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.188', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.701', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.65', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.271', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.7', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.63', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.445', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.60', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.714', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.515', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.778', 'groupIds': ['OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 (Week 4) and Stage 2 (Week 8): Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)', 'description': 'The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, "Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?" Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration Versus Time Summary of PF-06372865: Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}], 'classes': [{'title': 'Week 2 : 0 Hour (n= 12, 10)', 'categories': [{'measurements': [{'value': '10.89', 'spread': '7.1367', 'groupId': 'OG000'}, {'value': '64.73', 'spread': '58.463', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 : 2 Hour (n= 13, 10)', 'categories': [{'measurements': [{'value': '20.76', 'spread': '10.060', 'groupId': 'OG000'}, {'value': '113.8', 'spread': '55.517', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 : 4 Hour (n= 5, 8)', 'categories': [{'measurements': [{'value': '16.07', 'spread': '18.541', 'groupId': 'OG000'}, {'value': '77.75', 'spread': '65.594', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 : 10 Hour (n= 5, 9)', 'categories': [{'measurements': [{'value': '17.41', 'spread': '14.951', 'groupId': 'OG000'}, {'value': '66.60', 'spread': '53.888', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 : 0 Hour (n= 6, 5)', 'categories': [{'measurements': [{'value': '11.62', 'spread': '10.440', 'groupId': 'OG000'}, {'value': '33.44', 'spread': '34.409', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 : 2 Hour (n= 6, 4)', 'categories': [{'measurements': [{'value': '16.42', 'spread': '13.626', 'groupId': 'OG000'}, {'value': '54.02', 'spread': '54.091', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 : 4 Hour (n= 10, 9)', 'categories': [{'measurements': [{'value': '22.20', 'spread': '19.110', 'groupId': 'OG000'}, {'value': '81.58', 'spread': '54.133', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 : 10 Hour (n= 10, 9)', 'categories': [{'measurements': [{'value': '19.40', 'spread': '13.880', 'groupId': 'OG000'}, {'value': '73.31', 'spread': '57.082', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : 0 Hour (n= 7, 9)', 'categories': [{'measurements': [{'value': '14.36', 'spread': '18.770', 'groupId': 'OG000'}, {'value': '27.15', 'spread': '20.840', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : 2 Hour (n= 8, 10)', 'categories': [{'measurements': [{'value': '26.32', 'spread': '20.328', 'groupId': 'OG000'}, {'value': '61.98', 'spread': '21.457', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : 4 Hour (n= 11, 5)', 'categories': [{'measurements': [{'value': '29.58', 'spread': '12.398', 'groupId': 'OG000'}, {'value': '79.00', 'spread': '69.914', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 : 10 Hour (n= 10, 5)', 'categories': [{'measurements': [{'value': '28.48', 'spread': '11.550', 'groupId': 'OG000'}, {'value': '78.60', 'spread': '81.529', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Stage 1 full analysis set: All randomized participants who received at least 1 dose of study treatment. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Plasma Concentration Versus Time Summary of PF-06372865: Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG001', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'title': 'Week 6 : 0 Hour (n= 3, 2)', 'categories': [{'measurements': [{'value': '23.12', 'spread': '22.644', 'groupId': 'OG000'}, {'value': '35.67', 'spread': '31.015', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 : 2 Hour (n= 5, 3)', 'categories': [{'measurements': [{'value': '24.62', 'spread': '16.959', 'groupId': 'OG000'}, {'value': '59.40', 'spread': '46.218', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 : 4 Hour (n= 2, 3)', 'categories': [{'measurements': [{'value': '16.83', 'spread': '19.459', 'groupId': 'OG000'}, {'value': '75.98', 'spread': '60.380', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 : 10 Hour (n= 2, 3)', 'categories': [{'measurements': [{'value': '14.00', 'spread': '16.191', 'groupId': 'OG000'}, {'value': '66.43', 'spread': '52.402', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 : 0 Hour (n= 3, 3)', 'categories': [{'measurements': [{'value': '25.88', 'spread': '20.591', 'groupId': 'OG000'}, {'value': '17.54', 'spread': '9.7180', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 : 2 Hour (n= 4, 2)', 'categories': [{'measurements': [{'value': '24.54', 'spread': '17.913', 'groupId': 'OG000'}, {'value': '16.40', 'spread': '14.262', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 : 4 Hour (n= 3, 4)', 'categories': [{'measurements': [{'value': '34.80', 'spread': '44.089', 'groupId': 'OG000'}, {'value': '57.28', 'spread': '38.837', 'groupId': 'OG001'}]}]}, {'title': 'Week 7 : 10 Hour (n= 3, 4)', 'categories': [{'measurements': [{'value': '33.54', 'spread': '38.779', 'groupId': 'OG000'}, {'value': '64.45', 'spread': '22.420', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 : 0 Hour (n= 3, 5)', 'categories': [{'measurements': [{'value': '25.18', 'spread': '17.783', 'groupId': 'OG000'}, {'value': '32.73', 'spread': '25.175', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 : 2 Hour (n= 4, 6)', 'categories': [{'measurements': [{'value': '34.55', 'spread': '14.856', 'groupId': 'OG000'}, {'value': '48.83', 'spread': '39.032', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 : 4 Hour (n= 4, 3)', 'categories': [{'measurements': [{'value': '13.54', 'spread': '15.435', 'groupId': 'OG000'}, {'value': '13.54', 'spread': '15.435', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 : 10 Hour (n= 3, 2)', 'categories': [{'measurements': [{'value': '14.00', 'spread': '15.880', 'groupId': 'OG000'}, {'value': '14.00', 'spread': '15.880', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Placebo Non-Responder set for Stage 2. Participants who received PF-06372865 2.5 mg or PF-06372865 7.5 mg were evaluable for this measure. Here,'n' signifies those participants who were evaluable at specified time point for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'title': 'Baseline: S1 and S2 (n=45,24,21,6,8,8)', 'categories': [{'measurements': [{'value': '16.5', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '2.36', 'groupId': 'OG001'}, {'value': '16.1', 'spread': '1.77', 'groupId': 'OG002'}, {'value': '15.5', 'spread': '2.88', 'groupId': 'OG003'}, {'value': '13.0', 'spread': '4.54', 'groupId': 'OG004'}, {'value': '12.9', 'spread': '3.87', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '3.87', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '-3.2', 'spread': '2.87', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '2.88', 'groupId': 'OG003'}, {'value': '-0.6', 'spread': '2.83', 'groupId': 'OG004'}, {'value': '0.3', 'spread': '1.28', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W2, S2: W6 (n=39,23,21,6,8,8)', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '4.97', 'groupId': 'OG001'}, {'value': '-4.6', 'spread': '4.35', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '2.86', 'groupId': 'OG003'}, {'value': '0.4', 'spread': '2.97', 'groupId': 'OG004'}, {'value': '-0.6', 'spread': '2.20', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W3, S2: W7 (n=39,22,21,6,8,7)', 'categories': [{'measurements': [{'value': '-5.3', 'spread': '4.21', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '4.53', 'groupId': 'OG001'}, {'value': '-5.4', 'spread': '3.63', 'groupId': 'OG002'}, {'value': '-1.7', 'spread': '2.42', 'groupId': 'OG003'}, {'value': '-2.3', 'spread': '3.28', 'groupId': 'OG004'}, {'value': '-0.7', 'spread': '1.80', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W4, S2: W8 (n=40,22,20,6,8,7)', 'categories': [{'measurements': [{'value': '-5.9', 'spread': '4.63', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '5.19', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '3.89', 'groupId': 'OG002'}, {'value': '-2.5', 'spread': '3.56', 'groupId': 'OG003'}, {'value': '-3.9', 'spread': '3.27', 'groupId': 'OG004'}, {'value': '-1.6', 'spread': '3.05', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.562', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.5', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.93', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.708', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '1.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.92', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.852', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.347', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.1', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.14', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.574', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.7', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.28', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.831', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.09', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.705', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.10', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.600', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.7', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.24', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.848', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.23', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.237', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.5', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '3.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.24', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.224', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.7', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.40', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.747', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '2.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'LS Mean Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.764', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.37', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28). Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.487', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '3.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.22', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.744', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '3.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.53', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.340', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.5', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '4.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.52', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.477', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.0', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.36', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.482', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.51', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.719', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.5', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.49', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.245', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.6', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '4.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.36', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.586', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '4.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.93', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.440', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.5', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.90', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.159', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.6', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '5.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.75', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.720', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.15', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.991', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.13', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.704', 'groupIds': ['OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.12', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)', 'description': 'The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'title': 'Baseline: S1 and S2 (n=45,24,21,6,8,8)', 'categories': [{'measurements': [{'value': '11.5', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '3.15', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '4.01', 'groupId': 'OG002'}, {'value': '10.7', 'spread': '5.20', 'groupId': 'OG003'}, {'value': '9.5', 'spread': '2.98', 'groupId': 'OG004'}, {'value': '9.6', 'spread': '3.34', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W1, S2: W5 (n=41,24, 21,6,8,8)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.90', 'groupId': 'OG001'}, {'value': '-2.4', 'spread': '2.77', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '3.78', 'groupId': 'OG003'}, {'value': '-0.8', 'spread': '2.60', 'groupId': 'OG004'}, {'value': '0.4', 'spread': '2.07', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W2, S2: W6 (n=39,23,21,6,8,8)', 'categories': [{'measurements': [{'value': '-3.2', 'spread': '3.09', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '2.24', 'groupId': 'OG001'}, {'value': '-2.9', 'spread': '4.27', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '4.68', 'groupId': 'OG003'}, {'value': '-1.1', 'spread': '2.03', 'groupId': 'OG004'}, {'value': '-0.5', 'spread': '3.51', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W3, S2: W7 (n=39,22,21,6,8,7)', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '3.63', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '3.19', 'groupId': 'OG001'}, {'value': '-3.6', 'spread': '3.47', 'groupId': 'OG002'}, {'value': '-2.8', 'spread': '3.66', 'groupId': 'OG003'}, {'value': '-2.3', 'spread': '2.82', 'groupId': 'OG004'}, {'value': '-1.3', 'spread': '3.50', 'groupId': 'OG005'}]}]}, {'title': 'Change at S1: W4, S2: W8 (n=40,22,20,6,8,7)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '-3.7', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '-3.8', 'spread': '3.49', 'groupId': 'OG002'}, {'value': '-2.0', 'spread': '5.62', 'groupId': 'OG003'}, {'value': '-3.1', 'spread': '3.14', 'groupId': 'OG004'}, {'value': '-2.0', 'spread': '4.08', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.539', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.82', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.439', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.78', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.914', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.92', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 1: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.892', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.86', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.463', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.6', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.82', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.611', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.5', 'ciLowerLimit': '-2.1', 'ciUpperLimit': '1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.95', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.321', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '2.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.88', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.294', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.85', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.987', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.99', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 3: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.599', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.5', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.322', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '2.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.0', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.704', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.17', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 4: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.804', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '2.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'LS Mean Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.559', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.8', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.38', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.369', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '3.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.27', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 5: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.313', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.6', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '4.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.56', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.560', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '3.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.56', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.635', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '3.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.43', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 6: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.538', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '3.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.62', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.942', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '2.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.60', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.555', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.50', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 7: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.728', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.7', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '2.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.96', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.362', 'groupIds': ['OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.8', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '1.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.95', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.538', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '4.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.81', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Week 8: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect. Baseline for Stage 1 was Day 1 and baseline for Stage 2 was Week 4 (Day 28).', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.949', 'groupIds': ['OG000', 'OG002', 'OG003', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '1.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.11', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.708', 'groupIds': ['OG000', 'OG001', 'OG003', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '1.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.09', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Combined Stage 1 and Stage 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.752', 'groupIds': ['OG001', 'OG002', 'OG004', 'OG005'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.07', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Combined Stage 1 and Stage 2: Repeated measures model included week\\*treatment and baseline\\*week interaction as fixed effects, week repeated in each participant as repeated effect.', 'statisticalMethod': 'Mixed-Effects Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)', 'description': 'The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set for Stage 1 and Placebo Non-Responder set for Stage 2. Here, 'N' signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (Stage 1)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG001', 'title': 'PF-06372865 2.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG002', 'title': 'PF-06372865 7.5 mg (Stage 1)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.'}, {'id': 'OG003', 'title': 'Placebo (Stage 2)', 'description': 'All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.'}, {'id': 'OG004', 'title': 'PF-06372865 2.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.'}, {'id': 'OG005', 'title': 'PF-06372865 7.5 mg (Stage 2)', 'description': 'All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000'}, {'value': '12.50', 'groupId': 'OG001'}, {'value': '4.76', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '12.50', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.95', 'ciLowerLimit': '0.37', 'ciUpperLimit': '2.45', 'groupDescription': '(PF-06372865 7.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.64', 'ciLowerLimit': '0.39', 'ciUpperLimit': '6.88', 'groupDescription': '(PF-06372865 2.5 mg - Placebo). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.58', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.49', 'groupDescription': '(PF-06372865 7.5 mg - PF-06372865 2.5 mg). Logistic regression model includes treatment as fixed effect, and baseline as covariate. Baseline for Stage 1 is Day 1 and Stage 2 is Week 4 (Day 28).', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8', 'description': 'Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for Stage 1 was defined as all participants randomized and who had received at least 1 dose of randomized treatment. The Stage 2 placebo non-responder set was defined as the subset of subjects in the Stage 2 placebo set who had both a \\<50% reduction in HAM-A between Stage 1 baseline and Week 4, and HAM-A value of \\>= 16 at Week 4.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Placebo', 'description': 'Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.'}, {'id': 'FG001', 'title': 'Placebo + PF-06372865 2.5 mg', 'description': 'Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.'}, {'id': 'FG002', 'title': 'Placebo + PF-06372865 7.5 mg', 'description': 'Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.'}, {'id': 'FG003', 'title': 'PF-06372865 2.5 mg + Placebo', 'description': 'Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.'}, {'id': 'FG004', 'title': 'PF-06372865 7.5 mg + Placebo', 'description': 'Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.'}], 'periods': [{'title': 'Stage 1 ( 4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'No Longer Meets Eligibility Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Stage 2 (4 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was a sequential parallel study consisting of 2 stages: 4 week randomized treatment period (Stage 1) followed by a 4 week treatment period (Stage 2). Participants randomized to placebo for Stage 1, received either PF-06372865 or placebo in Stage 2 and participants randomized to PF-06372865 in Stage 1 were assigned to Placebo in Stage 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Placebo', 'description': 'Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.'}, {'id': 'BG001', 'title': 'Placebo + PF-06372865 2.5 mg', 'description': 'Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2.'}, {'id': 'BG002', 'title': 'Placebo + PF-06372865 7.5 mg', 'description': 'Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.'}, {'id': 'BG003', 'title': 'PF-06372865 2.5 mg + Placebo', 'description': 'Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.'}, {'id': 'BG004', 'title': 'PF-06372865 7.5 mg + Placebo', 'description': 'Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '12.4', 'groupId': 'BG000'}, {'value': '47.1', 'spread': '15.6', 'groupId': 'BG001'}, {'value': '42.7', 'spread': '13.8', 'groupId': 'BG002'}, {'value': '38.8', 'spread': '14', 'groupId': 'BG003'}, {'value': '42', 'spread': '12', 'groupId': 'BG004'}, {'value': '41.2', 'spread': '13.7', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'whyStopped': 'Study recruitment was terminated on 24 June 2015, due to a Pfizer business decision. This study was not terminated for reasons of safety or efficacy', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2014-10-24', 'resultsFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2017-01-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-26', 'studyFirstPostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Baseline: Stage 1 and 2', 'timeFrame': 'Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.'}, {'measure': 'Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4: Stage 1', 'timeFrame': 'Week 4', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.'}, {'measure': 'Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 4 During Stage 1 and at Week 8 During Stage 2', 'timeFrame': 'Stage 1: Week 4, Stage 2: Week 8', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 5, Week 6, Week 7 and Week 8: Stage 2', 'timeFrame': 'Week 5, 6, 7, 8', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.'}, {'measure': 'Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores at Baseline: Stage 1 and Stage 2', 'timeFrame': 'Stage 1: Baseline (Day 1 ), Stage 2: Baseline (Day 28)', 'description': 'SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.'}, {'measure': 'Change From Baseline in Sheehan Disability Scale (SDS) Total Score and Social, Work, Family Subscale Scores: Stage 1 and Stage 2', 'timeFrame': 'Stage 1: Week 4, Stage 2: Week 8', 'description': 'SDS was a copyrighted, three question instrument designed to assess functional impairment associated with mental disorders in three domains: work impairment, social impairment, and impairment of family life or home responsibilities. Disability scores were reported for each of the questions (subscale scores range from 0 to 10) and a total disability score was calculated as the sum of scores for each question (total scores range from 0 to 30). Higher scores reflect greater impairment.'}, {'measure': 'Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Scores at Week 1, Week 2 and Week 3: Stage 1', 'timeFrame': 'Week 1, 2, 3', 'description': 'The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.'}, {'measure': 'Percentage of Responders of Total Hamilton Anxiety Rating Scale (HAM-A): Stage 1 and Stage 2', 'timeFrame': 'Stage 1: Week 4, Stage 2: Week 8', 'description': 'A responder was defined as a participant with \\>= to 50 percent decrease in their total HAM-A score from baseline to the last week in the stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety. Percentage of responders of total HMA scale were reported.'}, {'measure': 'Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2', 'timeFrame': 'Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)', 'description': 'CGI-I was a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse) on the scale. Higher score indicated more affected. Change is equal to score at observation minus score at baseline.'}, {'measure': 'Change From Baseline in Clinical Global Impression -Severity (CGI-S) Scale Score at Week 1, 2, 3, 4 in Stage 1 and Week 5, 6, 7, 8 in Stage 2', 'timeFrame': 'Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)', 'description': 'The CGI-S consisted of a single 7-point rating score of illness severity, was completed by a clinician. Raters selected one response based on the following question, "Considering your total clinical experience with that particular population, how mentally ill was your participant at that time?" Scores were: 1 (normal, not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill) 6 (severely ill) or 7 (among the most severely ill participants). Higher scores indicate more severity.'}, {'measure': 'Plasma Concentration Versus Time Summary of PF-06372865: Stage 1', 'timeFrame': 'Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 2, 3, 4', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 nanogram per milliliter (ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.'}, {'measure': 'Plasma Concentration Versus Time Summary of PF-06372865: Stage 2', 'timeFrame': 'Pre-dose (0 hour), 2, 4, 10 hours post dose on Day 1 of Week 6, 7, 8', 'description': 'Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.0100 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.'}, {'measure': 'Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Psychic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8', 'timeFrame': 'Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)', 'description': 'The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Psychic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.'}, {'measure': 'Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A): Somatic Subscale Score at Week 1, 2, 3, 4, 5, 6, 7, 8', 'timeFrame': 'Stage 1 (S1): Baseline (Day 1), Week 1 (W1), 2 (W2), 3 (W3), 4 (W4) and Stage 2 (S2): Baseline (Day 28), Week 5 (W5), 6 (W6), 7 (W7), 8 (W8)', 'description': 'The HAM-A scale was a clinician interview-administered scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Somatic subscale of the HAM-A was the sum of 7 items. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 28 (very severe), where lower scores indicates less anxiety.'}, {'measure': 'Percentage of Participants With Remission of Total Hamilton Anxiety Rating Scale (HAM-A) Scores', 'timeFrame': 'Stage 1: Week 1 up to Week 4 and Stage 2: Week 5 up to Week 8', 'description': 'Percentage of participants with HAM-A total score less than or equal to 7 in the last week of the Stage (Week 4 in Stage 1, Week 8 in Stage 2). The HAM-A scale was a clinician rated interview scale designed to measure the signs and symptoms of anxiety. It had 14-items to rate the intensity of psychic and somatic anxiety on a 5-point severity scale. Each item ranging from 0 (not present) to 4 (very severe) were summed up to give a total possible score of 0 (not present) to 56 (very severe), where lower scores indicates less anxiety.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PF 06372865', 'generalized anxiety disorder', 'outpatient', 'safety', 'efficacy', 'suboptimal response'], 'conditions': ['Generalized Anxiety Disorder']}, 'referencesModule': {'references': [{'pmid': '29721364', 'type': 'DERIVED', 'citation': 'Targum SD, Murphy C, Khan J, Zumpano L, Whitlock M, Simen AA, Binneman B. Audio Recording for Independent Confirmation of Clinical Assessments in Generalized Anxiety Disorder. Innov Clin Neurosci. 2018 Apr 1;15(3-4):37-42.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7431007&StudyName=An%208-week%2C%20Randomized%2C%20Phase%202%2C%20Double-blind%2C%20Sequential%20Parallel-group%20Comparison%20Study%20Of%20Two%20Dose%20Levels%20Of%20Pf%2006372865%20Compared%20To%20Placebo%20As%20An%20Adjunctive%20Treatment%20In%20Outpatients%20With%20Inadequate%20Response%20To%20Standard%20Of%20Care%20For%20Generalized%20Anxiety%20Disorder', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate whether PF-06372865 is safe and effective in the treatment of sub-optimally controlled symptoms of generalized anxiety disorder during two 4-week treatment periods using a Sequential Parallel Comparison Design (SPCD). The study will use the Hamilton Anxiety Rating Scale (HAM-A) to measure change in symptoms from baseline for two doses of PF-06372865 compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Outpatient males and females 18 65 years of age (inclusive).\n2. Diagnostic and Statistical Manual of Mental Disorders Fourth edition Text Revised (DSM IV TR) diagnosis of GAD (DSM IV TR, 300.02), confirmed as primary diagnosis by the Mini international neuropsychiatric interview (MINI) structured interview.\n3. All subjects must have a total HAM A (via SIGH A) score 22 at screening. In addition, scores at the baseline visit must also be within 20% of scores at screening.\n4. Subjects must also have a Covi Anxiety Scale score of 9 and a Raskin Depression Scale score 7 at the Screening (Visit 1) visit to ensure predominance of anxiety symptoms over depression symptoms.\n5. Taking an FDA approved GAD treatment (escitalopram 10 to 20 mg total daily dose, paroxetine 20 to 50 mg total daily dose, duloxetine 60 to 120 mg total daily dose, or venlafaxine 75 to 225 mg total daily dose) at a stable FDA approved dosage for at least the two consecutive months in the current episode immediately prior to the screening visit. Sertraline or citalopram are also permitted as background treatment for GAD at doses of 50 to 200 mg total daily dose and 20 to 40 mg total daily dose, respectively.\n\nExclusion criteria:\n\n1. Subjects with a history of daily benzodiazepine use within one month of the screening visit.\n2. Recent (defined as meeting disorder diagnostic criteria during the last 6 months) of a DSM IV TR Axis I diagnosis other than generalized anxiety disorder, with the following exceptions: a. Subjects with recent (in the last 2 months) major depressive disorder may be enrolled if the anxiety symptoms are predominant over the depressive symptoms, as judged by the Covi/Raskin criteria listed above and confirmed GAD as the primary diagnosis by the MINI structured interview. b. Comorbid social phobia and/or specific phobias are permitted as long as the anxiety symptoms due to these disorders are clinically less significant than the anxiety symptoms due to GAD and GAD is confirmed as the primary diagnosis by the MINI structured interview.\n3. Recent (defined as meeting disorder diagnostic criteria during the last 6 months) of a DSM IV TR Axis I of panic disorder with or without agoraphobia, Post Traumatic Stress Disorder (PTSD), dissociative disorder, obsessive compulsive disorder, attention deficit disorder. If a subject has a past misdiagnosis of any of these disorders, or if the subject has another psychiatric disorder that in the opinion of the investigator affects the suitability of a subject for this study based on safety or other considerations, the investigator will need to contact the sponsor prior to screening.\n4. Past and/or current DSM IV TR diagnosis of schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorders (I or II), factitious disorder or cognitive disorder (including delirium, dementia, and amnestic disorder).\n5. Presence of comorbid personality disorders (Axis II) based on DSM IV TR.\n6. Subjects who meet DSM IV TR defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM IV TR defined substance abuse within 3 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT02310568', 'briefTitle': 'POC Study in Partially Responsive Generalized Anxiety Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An 8-week, Randomized, Phase 2, Double-blind, Sequential Parallel-group Comparison Study Of Two Dose Levels Of Pf 06372865 Compared To Placebo As An Adjunctive Treatment In Outpatients With Inadequate Response To Standard Of Care For Generalized Anxiety Disorder', 'orgStudyIdInfo': {'id': 'B7431007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF 06372865 2.5 mg BID then placebo.', 'description': 'PF 06372865 2.5 mg tablet 2 times daily for 4 weeks (Stage 1), followed by placebo 2 times daily for 4 weeks (Stage 2).', 'interventionNames': ['Drug: PF-06372865.']}, {'type': 'EXPERIMENTAL', 'label': 'PF 06372865 7.5 mg BID then placebo.', 'description': 'PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 1), followed by placebo (2 times daily) for 4 weeks (Stage 2).', 'interventionNames': ['Drug: PF-06372865.']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then PF 06372865 2.5 mg BID.', 'description': 'Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for 4 weeks', 'interventionNames': ['Drug: PF-06372865.']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo then PF 06372865 7.5 mg BID.', 'description': 'Placebo 2 times daily for 4 weeks (Stage 1), followed by PF 06372865 2.5 mg tablet 2 times daily for one week, then PF 06372865 7.5 mg tablet 2 times daily for 3 weeks (Stage 2).', 'interventionNames': ['Drug: PF-06372865.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo followed by placebo.', 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