Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-04-03 @ 5:25 AM
Study NCT ID:
NCT02942004
Status:
COMPLETED
Last Update Posted:
2025-10-14
First Post:
2016-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['New Zealand']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625635', 'term': 'brexanolone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@sagerx.com', 'phone': '617-299-8380', 'title': 'Medical Monitor', 'organization': 'Sage Therapeutics'}, 'certainAgreement': {'otherDetails': 'The PI can either be a party and subject to the same restrictions as the institution, or if not a party, the restrictions are described on the face of the contract (i.e., PI is a contractor of the institution; PI is part of a larger group of study personnel; institution has contracted with or otherwise bound all study personnel under confidentiality obligations and requirements to vest intellectual property to the institution).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 37 days.', 'description': 'The Safety Set included all randomized participants who started the study drug infusion.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 9, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 17, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 13, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}], 'seriousEvents': [{'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.04', 'spread': '1.148', 'groupId': 'OG000'}, {'value': '-19.54', 'spread': '1.231', 'groupId': 'OG001'}, {'value': '-17.72', 'spread': '1.193', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.50', 'ciLowerLimit': '-8.80', 'ciUpperLimit': '-2.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.664', 'groupDescription': 'Mixed effect model for repeated measures (MMRM) was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0252', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.68', 'ciLowerLimit': '-6.90', 'ciUpperLimit': '-0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.622', 'groupDescription': 'MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Hour 60', 'description': 'The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAM-D Total Score at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.82', 'spread': '1.324', 'groupId': 'OG000'}, {'value': '-19.45', 'spread': '1.435', 'groupId': 'OG001'}, {'value': '-17.62', 'spread': '1.400', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.63', 'ciLowerLimit': '-9.46', 'ciUpperLimit': '-1.79', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.936', 'groupDescription': 'MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0481', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.79', 'ciLowerLimit': '-7.56', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.899', 'groupDescription': 'MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 30', 'description': 'The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Overall number of participants analyzed is the number of participants with data available for analysis at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAM-D Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Change at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.04', 'spread': '0.669', 'groupId': 'OG000'}, {'value': '-4.99', 'spread': '0.721', 'groupId': 'OG001'}, {'value': '-4.89', 'spread': '0.707', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.88', 'spread': '0.841', 'groupId': 'OG000'}, {'value': '-8.99', 'spread': '0.902', 'groupId': 'OG001'}, {'value': '-7.18', 'spread': '0.879', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.13', 'spread': '0.928', 'groupId': 'OG000'}, {'value': '-10.18', 'spread': '0.994', 'groupId': 'OG001'}, {'value': '-8.50', 'spread': '0.966', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.79', 'spread': '0.992', 'groupId': 'OG000'}, {'value': '-11.04', 'spread': '1.069', 'groupId': 'OG001'}, {'value': '-9.07', 'spread': '1.034', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.71', 'spread': '1.121', 'groupId': 'OG000'}, {'value': '-15.00', 'spread': '1.199', 'groupId': 'OG001'}, {'value': '-13.03', 'spread': '1.157', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-12.58', 'spread': '1.114', 'groupId': 'OG000'}, {'value': '-17.69', 'spread': '1.203', 'groupId': 'OG001'}, {'value': '-13.93', 'spread': '1.157', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.55', 'spread': '1.195', 'groupId': 'OG000'}, {'value': '-18.04', 'spread': '1.282', 'groupId': 'OG001'}, {'value': '-16.89', 'spread': '1.239', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.67', 'spread': '1.197', 'groupId': 'OG000'}, {'value': '-19.69', 'spread': '1.285', 'groupId': 'OG001'}, {'value': '-17.19', 'spread': '1.243', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.34', 'spread': '1.268', 'groupId': 'OG000'}, {'value': '-17.41', 'spread': '1.353', 'groupId': 'OG001'}, {'value': '-14.93', 'spread': '1.315', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.64', 'spread': '1.457', 'groupId': 'OG000'}, {'value': '-17.56', 'spread': '1.586', 'groupId': 'OG001'}, {'value': '-15.64', 'spread': '1.521', 'groupId': 'OG002'}]}]}, {'title': 'Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-13.23', 'spread': '1.380', 'groupId': 'OG000'}, {'value': '-18.15', 'spread': '1.529', 'groupId': 'OG001'}, {'value': '-16.74', 'spread': '1.451', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9591', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-1.83', 'ciUpperLimit': '1.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.951', 'groupDescription': 'Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8677', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '1.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.917', 'groupDescription': 'Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0827', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.11', 'ciLowerLimit': '-4.51', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.208', 'groupDescription': 'Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7968', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-2.62', 'ciUpperLimit': '2.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.172', 'groupDescription': 'Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1292', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.04', 'ciLowerLimit': '-4.69', 'ciUpperLimit': '0.61', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.336', 'groupDescription': 'Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7801', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-2.94', 'ciUpperLimit': '2.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.299', 'groupDescription': 'Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3840', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.25', 'ciLowerLimit': '-4.10', 'ciUpperLimit': '1.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.436', 'groupDescription': 'Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6097', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.71', 'paramValue': '0.71', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '3.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.395', 'groupDescription': 'Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.28', 'ciLowerLimit': '-7.50', 'ciUpperLimit': '-1.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.622', 'groupDescription': 'Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1440', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.32', 'ciLowerLimit': '-5.45', 'ciUpperLimit': '0.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.577', 'groupDescription': 'Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.12', 'ciLowerLimit': '-8.33', 'ciUpperLimit': '-1.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.620', 'groupDescription': 'Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3906', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.36', 'ciLowerLimit': '-4.47', 'ciUpperLimit': '1.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.572', 'groupDescription': 'Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.49', 'ciLowerLimit': '-7.93', 'ciUpperLimit': '-1.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.735', 'groupDescription': 'Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0511', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.33', 'ciLowerLimit': '-6.68', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.690', 'groupDescription': 'Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0046', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.02', 'ciLowerLimit': '-8.47', 'ciUpperLimit': '-1.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.738', 'groupDescription': 'Change at hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1389', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.53', 'ciLowerLimit': '-5.88', 'ciUpperLimit': '0.83', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.694', 'groupDescription': 'Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0288', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.07', 'ciLowerLimit': '-7.71', 'ciUpperLimit': '-0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.837', 'groupDescription': 'Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3799', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.58', 'ciLowerLimit': '-5.15', 'ciUpperLimit': '1.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.797', 'groupDescription': 'Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1747', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.92', 'ciLowerLimit': '-7.16', 'ciUpperLimit': '1.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.139', 'groupDescription': 'Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6310', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.00', 'ciLowerLimit': '-5.13', 'ciUpperLimit': '3.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.080', 'groupDescription': 'Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0178', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.92', 'ciLowerLimit': '-8.98', 'ciUpperLimit': '-0.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.045', 'groupDescription': 'Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0786', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.51', 'ciLowerLimit': '-7.43', 'ciUpperLimit': '0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.976', 'groupDescription': 'Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D total score at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14, and 21', 'description': 'The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HAM-D Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}, {'value': '86.5', 'groupId': 'OG001'}, {'value': '74.4', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '68.4', 'groupId': 'OG001'}, {'value': '52.5', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}, {'value': '82.9', 'groupId': 'OG001'}, {'value': '69.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '1.7', 'ciUpperLimit': '17.4', 'groupDescription': 'Hour 60: Generalized estimating equation (GEE) method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0493', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.0', 'ciUpperLimit': '6.9', 'groupDescription': 'Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0572', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '1.0', 'ciUpperLimit': '6.5', 'groupDescription': 'Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6768', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.5', 'ciUpperLimit': '3.0', 'groupDescription': 'Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '1.7', 'ciUpperLimit': '16.8', 'groupDescription': 'Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0347', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '1.1', 'ciUpperLimit': '7.8', 'groupDescription': 'Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 60, Days 7 and 30', 'description': 'The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HAM-D Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '51.4', 'groupId': 'OG001'}, {'value': '30.8', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000'}, {'value': '31.6', 'groupId': 'OG001'}, {'value': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000'}, {'value': '48.6', 'groupId': 'OG001'}, {'value': '38.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.0', 'ciLowerLimit': '2.1', 'ciUpperLimit': '17.8', 'groupDescription': 'Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0828', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '0.9', 'ciUpperLimit': '7.6', 'groupDescription': 'Hour 60: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7749', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.4', 'ciUpperLimit': '3.1', 'groupDescription': 'Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3401', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.2', 'ciUpperLimit': '1.7', 'groupDescription': 'Day 7: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '0.8', 'ciUpperLimit': '6.0', 'groupDescription': 'Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3507', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '0.6', 'ciUpperLimit': '4.2', 'groupDescription': 'Day 30: GEE method was used for analysis. The HAM-D response at each visit was the dependent variable. Treatment, baseline HAM-D total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. An exchangeable working correlation structure is assumed for the model parameters estimation.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 60, Days 7 and 30', 'description': 'The HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAM-D Bech 6 Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-32.60', 'spread': '2.962', 'groupId': 'OG000'}, {'value': '-44.67', 'spread': '3.178', 'groupId': 'OG001'}, {'value': '-38.49', 'spread': '3.081', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-29.43', 'spread': '3.116', 'groupId': 'OG000'}, {'value': '-38.52', 'spread': '3.327', 'groupId': 'OG001'}, {'value': '-31.67', 'spread': '3.236', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-30.94', 'spread': '3.122', 'groupId': 'OG000'}, {'value': '-42.62', 'spread': '3.385', 'groupId': 'OG001'}, {'value': '-39.20', 'spread': '3.304', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.07', 'ciLowerLimit': '-20.58', 'ciUpperLimit': '-3.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.294', 'groupDescription': 'Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1622', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.89', 'ciLowerLimit': '-14.19', 'ciUpperLimit': '2.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.188', 'groupDescription': 'Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0462', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.09', 'ciLowerLimit': '-18.02', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.510', 'groupDescription': 'Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6124', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.24', 'ciLowerLimit': '-10.97', 'ciUpperLimit': '6.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.410', 'groupDescription': 'Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.68', 'ciLowerLimit': '-20.71', 'ciUpperLimit': '-2.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.556', 'groupDescription': 'Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0667', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.26', 'ciLowerLimit': '-17.10', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.464', 'groupDescription': 'Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D subscales at each visit as the dependent variable. Treatment, baseline HAM-D subscales, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables are included in the model. All explanatory variables including pooled center are treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Hour 60, Days 7 and 30', 'description': 'The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HAM-D Individual Item Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Depressed Mood, Change at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.143', 'groupId': 'OG001'}, {'value': '-0.45', 'spread': '0.139', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.165', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '0.176', 'groupId': 'OG001'}, {'value': '-0.79', 'spread': '0.171', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'spread': '0.166', 'groupId': 'OG000'}, {'value': '-1.23', 'spread': '0.178', 'groupId': 'OG001'}, {'value': '-0.94', 'spread': '0.172', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '0.184', 'groupId': 'OG001'}, {'value': '-1.15', 'spread': '0.177', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '0.163', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '0.175', 'groupId': 'OG001'}, {'value': '-1.47', 'spread': '0.169', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Hour 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.47', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-2.03', 'spread': '0.184', 'groupId': 'OG001'}, {'value': '-1.49', 'spread': '0.176', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Hour 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.58', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '-2.07', 'spread': '0.186', 'groupId': 'OG001'}, {'value': '-1.84', 'spread': '0.180', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.56', 'spread': '0.169', 'groupId': 'OG000'}, {'value': '-2.27', 'spread': '0.181', 'groupId': 'OG001'}, {'value': '-1.92', 'spread': '0.176', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Hour 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '0.174', 'groupId': 'OG001'}, {'value': '-1.97', 'spread': '0.169', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.49', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-1.94', 'spread': '0.182', 'groupId': 'OG001'}, {'value': '-1.55', 'spread': '0.177', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.53', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-2.06', 'spread': '0.225', 'groupId': 'OG001'}, {'value': '-1.65', 'spread': '0.213', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '-1.79', 'spread': '0.229', 'groupId': 'OG001'}, {'value': '-1.75', 'spread': '0.214', 'groupId': 'OG002'}]}]}, {'title': 'Depressed Mood, Change at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.53', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '-2.19', 'spread': '0.186', 'groupId': 'OG001'}, {'value': '-1.97', 'spread': '0.183', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.46', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '-0.54', 'spread': '0.143', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '0.138', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.157', 'groupId': 'OG000'}, {'value': '-1.12', 'spread': '0.168', 'groupId': 'OG001'}, {'value': '-0.84', 'spread': '0.162', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '0.173', 'groupId': 'OG001'}, {'value': '-0.94', 'spread': '0.168', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.04', 'spread': '0.164', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '0.178', 'groupId': 'OG001'}, {'value': '-0.76', 'spread': '0.171', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.04', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-1.50', 'spread': '0.173', 'groupId': 'OG001'}, {'value': '-1.03', 'spread': '0.167', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.150', 'groupId': 'OG000'}, {'value': '-1.59', 'spread': '0.162', 'groupId': 'OG001'}, {'value': '-1.26', 'spread': '0.156', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.25', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '-1.64', 'spread': '0.163', 'groupId': 'OG001'}, {'value': '-1.60', 'spread': '0.158', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.23', 'spread': '0.149', 'groupId': 'OG000'}, {'value': '-1.68', 'spread': '0.160', 'groupId': 'OG001'}, {'value': '-1.63', 'spread': '0.155', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Hour 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.42', 'spread': '0.145', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '0.157', 'groupId': 'OG001'}, {'value': '-1.57', 'spread': '0.152', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '0.152', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '0.163', 'groupId': 'OG001'}, {'value': '-1.36', 'spread': '0.159', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '0.173', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '0.169', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.10', 'spread': '0.162', 'groupId': 'OG000'}, {'value': '-1.51', 'spread': '0.181', 'groupId': 'OG001'}, {'value': '-1.51', 'spread': '0.171', 'groupId': 'OG002'}]}]}, {'title': 'Feelings of Guilt, Change at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '0.149', 'groupId': 'OG000'}, {'value': '-1.61', 'spread': '0.163', 'groupId': 'OG001'}, {'value': '-1.62', 'spread': '0.161', 'groupId': 'OG002'}]}]}, {'title': 'Suicide, Change at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '-0.87', 'spread': '0.107', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.104', 'groupId': 'OG002'}]}]}, {'title': 'Suicide, Change at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.64', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '-0.92', 'spread': '0.105', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.101', 'groupId': 'OG002'}]}]}, {'title': 'Suicide, Change at Hour 8', 'denoms': 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'groupId': 'OG001'}, {'value': '-0.28', 'spread': '0.102', 'groupId': 'OG002'}]}]}, {'title': 'Genital Symptoms, Change at Hour 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.111', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': '0.106', 'groupId': 'OG002'}]}]}, {'title': 'Genital Symptoms, Change at Hour 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.46', 'spread': '0.115', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '0.110', 'groupId': 'OG002'}]}]}, {'title': 'Genital Symptoms, Change at Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-0.48', 'spread': '0.116', 'groupId': 'OG001'}, {'value': '-0.67', 'spread': '0.112', 'groupId': 'OG002'}]}]}, {'title': 'Genital Symptoms, Change at Hour 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '0.115', 'groupId': 'OG001'}, {'value': '-0.72', 'spread': '0.110', 'groupId': 'OG002'}]}]}, {'title': 'Genital Symptoms, Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.51', 'spread': '0.113', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.120', 'groupId': 'OG001'}, {'value': '-0.79', 'spread': '0.117', 'groupId': 'OG002'}]}]}, {'title': 'Genital Symptoms, Change at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.131', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '0.144', 'groupId': 'OG001'}, {'value': '-0.83', 'spread': '0.138', 'groupId': 'OG002'}]}]}, {'title': 'Genital Symptoms, Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.68', 'spread': '0.141', 'groupId': 'OG000'}, {'value': '-0.90', 'spread': '0.159', 'groupId': 'OG001'}, {'value': '-0.87', 'spread': '0.147', 'groupId': 'OG002'}]}]}, {'title': 'Genital Symptoms, Change at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.131', 'groupId': 'OG000'}, {'value': '-0.97', 'spread': '0.143', 'groupId': 'OG001'}, {'value': '-0.95', 'spread': '0.140', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '-0.34', 'spread': '0.109', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '-0.39', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-0.34', 'spread': '0.116', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.114', 'groupId': 'OG000'}, {'value': '-0.47', 'spread': '0.122', 'groupId': 'OG001'}, {'value': '-0.41', 'spread': '0.118', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.109', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.118', 'groupId': 'OG001'}, {'value': '-0.44', 'spread': '0.114', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.112', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.109', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.104', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '-0.49', 'spread': '0.109', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.105', 'groupId': 'OG000'}, {'value': '-0.63', 'spread': '0.113', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.109', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.100', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '0.108', 'groupId': 'OG001'}, {'value': '-0.59', 'spread': '0.105', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Hour 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.098', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.106', 'groupId': 'OG001'}, {'value': '-0.55', 'spread': '0.103', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-0.68', 'spread': '0.102', 'groupId': 'OG001'}, {'value': '-0.58', 'spread': '0.100', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.132', 'groupId': 'OG001'}, {'value': '-0.51', 'spread': '0.127', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.107', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.119', 'groupId': 'OG001'}, {'value': '-0.57', 'spread': '0.114', 'groupId': 'OG002'}]}]}, {'title': 'Hypochondriasis, Change at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '0.099', 'groupId': 'OG000'}, {'value': '-0.66', 'spread': '0.109', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '0.108', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.057', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.061', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '0.059', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.052', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.055', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.054', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.060', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.064', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.062', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.068', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.074', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.071', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.084', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.090', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.086', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.082', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.079', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.089', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.086', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.095', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '0.102', 'groupId': 'OG001'}, {'value': '-0.35', 'spread': '0.098', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Hour 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.090', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.097', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '0.094', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '-0.36', 'spread': '0.137', 'groupId': 'OG001'}, {'value': '-0.60', 'spread': '0.135', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.150', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.164', 'groupId': 'OG001'}, {'value': '-0.64', 'spread': '0.158', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.49', 'spread': '0.160', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.177', 'groupId': 'OG001'}, {'value': '-0.61', 'spread': '0.169', 'groupId': 'OG002'}]}]}, {'title': 'Loss of Weight, Change at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.133', 'groupId': 'OG000'}, {'value': '-0.55', 'spread': '0.144', 'groupId': 'OG001'}, {'value': '-0.48', 'spread': '0.143', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Hour 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.040', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.039', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.041', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.045', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.044', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.047', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.044', 'groupId': 'OG002'}]}]}, {'title': 'Insight, Change at Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.041', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.041', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9681', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'groupDescription': 'Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6337', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Depressed Mood, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4690', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'groupDescription': 'Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9905', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.232', 'groupDescription': 'Depressed Mood, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3984', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.240', 'groupDescription': 'Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7042', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.234', 'groupDescription': 'Depressed Mood, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4941', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.247', 'groupDescription': 'Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4572', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.240', 'groupDescription': 'Depressed Mood, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9866', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.236', 'groupDescription': 'Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7490', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.229', 'groupDescription': 'Depressed Mood, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0235', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '-0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.247', 'groupDescription': 'Depressed Mood, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9286', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.239', 'groupDescription': 'Depressed Mood, Change Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0544', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.251', 'groupDescription': 'Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2903', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.244', 'groupDescription': 'Depressed Mood, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.71', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.244', 'groupDescription': 'Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1339', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'groupDescription': 'Depressed Mood, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0149', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '-0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.234', 'groupDescription': 'Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3213', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.228', 'groupDescription': 'Depressed Mood, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0703', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.246', 'groupDescription': 'Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8152', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.240', 'groupDescription': 'Depressed Mood, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0805', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-1.13', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.301', 'groupDescription': 'Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6964', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.291', 'groupDescription': 'Depressed Mood, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2998', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.304', 'groupDescription': 'Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3448', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.291', 'groupDescription': 'Depressed Mood, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0089', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.66', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '-0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.248', 'groupDescription': 'Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0772', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.244', 'groupDescription': 'Depressed Mood, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6809', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'groupDescription': 'Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7297', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Feelings of Guilt, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.226', 'groupDescription': 'Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5196', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.220', 'groupDescription': 'Feelings of Guilt, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0772', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.234', 'groupDescription': 'Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6610', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.228', 'groupDescription': 'Feelings of Guilt, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.239', 'groupDescription': 'Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2292', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.232', 'groupDescription': 'Feelings of Guilt, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0540', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.234', 'groupDescription': 'Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9590', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.227', 'groupDescription': 'Feelings of Guilt, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.218', 'groupDescription': 'Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8979', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.210', 'groupDescription': 'Feelings of Guilt, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0819', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.219', 'groupDescription': 'Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1099', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Feelings of Guilt, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.215', 'groupDescription': 'Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0577', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.209', 'groupDescription': 'Feelings of Guilt, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.210', 'groupDescription': 'Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4444', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.204', 'groupDescription': 'Feelings of Guilt, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3645', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.220', 'groupDescription': 'Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.214', 'groupDescription': 'Feelings of Guilt, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4877', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.232', 'groupDescription': 'Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3134', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.226', 'groupDescription': 'Feelings of Guilt, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0922', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.240', 'groupDescription': 'Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0761', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.230', 'groupDescription': 'Feelings of Guilt, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3275', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.217', 'groupDescription': 'Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3041', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Feelings of Guilt, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0450', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5351', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.143', 'groupDescription': 'Suicide, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0525', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS men difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.142', 'groupDescription': 'Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7932', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.139', 'groupDescription': 'Suicide, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1300', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.128', 'groupDescription': 'Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1631', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.125', 'groupDescription': 'Suicide, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0380', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.126', 'groupDescription': 'Suicide, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.124', 'groupDescription': 'Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1094', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.120', 'groupDescription': 'Suicide, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.099', 'groupDescription': 'Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1345', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.096', 'groupDescription': 'Suicide, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5148', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.091', 'groupDescription': 'Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3863', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.088', 'groupDescription': 'Suicide, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0209', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0616', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS men difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.092', 'groupDescription': 'Suicide, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1860', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.099', 'groupDescription': 'Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7730', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.095', 'groupDescription': 'Suicide, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1593', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6371', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.126', 'groupDescription': 'Suicide, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5655', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.124', 'groupDescription': 'Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3326', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.121', 'groupDescription': 'Suicide, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3577', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.201', 'groupDescription': 'Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1646', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.192', 'groupDescription': 'Suicide, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0545', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.118', 'groupDescription': 'Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2903', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.115', 'groupDescription': 'Suicide, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0395', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.112', 'groupDescription': 'Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4690', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.108', 'groupDescription': 'Insomnia - Early, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.20', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.139', 'groupDescription': 'Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9737', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.136', 'groupDescription': 'Insomnia - Early, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.148', 'groupDescription': 'Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6357', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'groupDescription': 'Insomnia - Early, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8605', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.134', 'groupDescription': 'Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7534', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.130', 'groupDescription': 'Insomnia - Early, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.201', 'groupDescription': 'Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0394', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.196', 'groupDescription': 'Insomnia - Early, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.208', 'groupDescription': 'Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1591', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.202', 'groupDescription': 'Insomnia - Early, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1402', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.210', 'groupDescription': 'Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0143', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.205', 'groupDescription': 'Insomnia - Early, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.204', 'groupDescription': 'Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0884', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.200', 'groupDescription': 'Insomnia - Early, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0622', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.207', 'groupDescription': 'Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0955', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.202', 'groupDescription': 'Insomnia - Early, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0173', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.210', 'groupDescription': 'Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1687', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.206', 'groupDescription': 'Insomnia - Early, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3861', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.258', 'groupDescription': 'Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7060', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.249', 'groupDescription': 'Insomnia - Early, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.230', 'groupDescription': 'Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0570', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.219', 'groupDescription': 'Insomnia - Early, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '-0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.208', 'groupDescription': 'Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0443', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.205', 'groupDescription': 'Insomnia - Early, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.104', 'groupDescription': 'Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7171', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.101', 'groupDescription': 'Insomnia - Middle, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7151', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.138', 'groupDescription': 'Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5210', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.134', 'groupDescription': 'Insomnia - Middle, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7332', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.142', 'groupDescription': 'Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4163', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.139', 'groupDescription': 'Insomnia - Middle, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8625', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'groupDescription': 'Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6196', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.128', 'groupDescription': 'Insomnia - Middle, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.197', 'groupDescription': 'Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0644', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'groupDescription': 'Insomnia - Middle, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1347', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'groupDescription': 'Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1269', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Insomnia - Middle, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1650', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.192', 'groupDescription': 'Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1291', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.188', 'groupDescription': 'Insomnia - Middle, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0402', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.189', 'groupDescription': 'Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0342', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Insomnia - Middle, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1269', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'groupDescription': 'Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3945', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.188', 'groupDescription': 'Insomnia - Middle, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5828', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6625', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.182', 'groupDescription': 'Insomnia - Middle, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0041', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.216', 'groupDescription': 'Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2222', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.210', 'groupDescription': 'Insomnia - Middle, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0245', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '-0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.218', 'groupDescription': 'Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5119', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.209', 'groupDescription': 'Insomnia - Middle, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0299', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.197', 'groupDescription': 'Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2824', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.195', 'groupDescription': 'Insomnia - Middle, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1768', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6498', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.126', 'groupDescription': 'Insomnia - Late, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7689', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2236', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Insomnia - Late, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6952', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.148', 'groupDescription': 'Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1184', 'groupIds': ['OG000'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.144', 'groupDescription': 'Insomnia - Late, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.149', 'groupDescription': 'Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3091', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'groupDescription': 'Insomnia - Late, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1525', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.179', 'groupDescription': 'Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1214', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.174', 'groupDescription': 'Insomnia - Late, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3811', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.187', 'groupDescription': 'Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3851', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'groupDescription': 'Insomnia - Late, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.182', 'groupDescription': 'Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1360', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.177', 'groupDescription': 'Insomnia - Late, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.176', 'groupDescription': 'Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0567', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Insomnia - Late, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7447', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.176', 'groupDescription': 'Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7727', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Insomnia - Late, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6590', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.183', 'groupDescription': 'Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3951', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'groupDescription': 'Insomnia - Late, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4576', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.230', 'groupDescription': 'Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7609', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.223', 'groupDescription': 'Insomnia - Late, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6220', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.234', 'groupDescription': 'Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9081', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.225', 'groupDescription': 'Insomnia - Late, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1668', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'groupDescription': 'Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0935', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.189', 'groupDescription': 'Insomnia - Late, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7559', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'groupDescription': 'Work and Activities, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.181', 'groupDescription': 'Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6334', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.175', 'groupDescription': 'Work and Activities, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5431', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.230', 'groupDescription': 'Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5278', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.59', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.225', 'groupDescription': 'Work and Activities, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4312', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.232', 'groupDescription': 'Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3947', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.225', 'groupDescription': 'Work and Activities, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6081', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.244', 'groupDescription': 'Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8949', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'groupDescription': 'Work and Activities, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.236', 'groupDescription': 'Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1842', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.228', 'groupDescription': 'Work and Activities, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2646', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.260', 'groupDescription': 'Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8101', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.253', 'groupDescription': 'Work and Activities, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0215', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.248', 'groupDescription': 'Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3226', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.242', 'groupDescription': 'Work and Activities, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0339', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'groupDescription': 'Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9824', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.232', 'groupDescription': 'Work and Activities, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0950', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.254', 'groupDescription': 'Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4865', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.249', 'groupDescription': 'Work and Activities, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9861', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.292', 'groupDescription': 'Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9266', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.283', 'groupDescription': 'Work and Activities, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0360', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.285', 'groupDescription': 'Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0583', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.273', 'groupDescription': 'Work and Activities, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0404', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.254', 'groupDescription': 'Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1352', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.249', 'groupDescription': 'Work and Activities, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.121', 'groupDescription': 'Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1537', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.118', 'groupDescription': 'Retardation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0142', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.32', 'ciLowerLimit': '0.07', 'ciUpperLimit': '0.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0159', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.126', 'groupDescription': 'Retardation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2255', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'groupDescription': 'Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1069', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Retardation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4932', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.144', 'groupDescription': 'Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2634', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.140', 'groupDescription': 'Retardation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9284', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'groupDescription': 'Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9459', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Retardation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2908', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6834', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Retardation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3579', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.142', 'groupDescription': 'Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8270', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.138', 'groupDescription': 'Retardation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5292', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.130', 'groupDescription': 'Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8790', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.127', 'groupDescription': 'Retardation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1347', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'groupDescription': 'Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2874', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Retardation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0086', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.132', 'groupDescription': 'Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7864', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Retardation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4383', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8767', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.167', 'groupDescription': 'Retardation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0341', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.153', 'groupDescription': 'Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5629', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'groupDescription': 'Retardation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.42', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0495', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.126', 'groupDescription': 'Retardation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7177', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.155', 'groupDescription': 'Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9401', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Agitation, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'groupDescription': 'Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8286', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.144', 'groupDescription': 'Agitation, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8022', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'groupDescription': 'Agitation, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5665', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.165', 'groupDescription': 'Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8170', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.161', 'groupDescription': 'Agitation, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0404', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.155', 'groupDescription': 'Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3128', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Agitation, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2400', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4840', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Agitation, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7768', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.141', 'groupDescription': 'Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7713', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.137', 'groupDescription': 'Agitation, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4317', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.148', 'groupDescription': 'Agitation, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2115', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2818', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'groupDescription': 'Agitation, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.140', 'groupDescription': 'Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6554', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.137', 'groupDescription': 'Agitation, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4754', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.168', 'groupDescription': 'Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7776', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.163', 'groupDescription': 'Agitation, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7172', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4791', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.203', 'groupDescription': 'Agitation, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.164', 'groupDescription': 'Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8859', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'Agitation, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5888', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.192', 'groupDescription': 'Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3992', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.187', 'groupDescription': 'Anxiety Psychic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1212', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.227', 'groupDescription': 'Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3185', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.221', 'groupDescription': 'Anxiety Psychic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4809', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.231', 'groupDescription': 'Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8953', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.225', 'groupDescription': 'Anxiety Psychic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5616', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.223', 'groupDescription': 'Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8571', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.216', 'groupDescription': 'Anxiety Psychic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0386', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.206', 'groupDescription': 'Anxiety Psychic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.216', 'groupDescription': 'Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8308', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.208', 'groupDescription': 'Anxiety Psychic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0388', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.215', 'groupDescription': 'Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1622', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.209', 'groupDescription': 'Anxiety Psychic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.204', 'groupDescription': 'Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4283', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.198', 'groupDescription': 'Anxiety Psychic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1899', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.219', 'groupDescription': 'Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8022', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.213', 'groupDescription': 'Anxiety Psychic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3780', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.215', 'groupDescription': 'Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8110', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.210', 'groupDescription': 'Anxiety Psychic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8908', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.272', 'groupDescription': 'Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3596', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.263', 'groupDescription': 'Anxiety Psychic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7617', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.293', 'groupDescription': 'Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5498', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.281', 'groupDescription': 'Anxiety Psychic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.235', 'groupDescription': 'Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2321', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.230', 'groupDescription': 'Anxiety Psychic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5582', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'groupDescription': 'Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2945', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.186', 'groupDescription': 'Anxiety Somatic, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2684', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.208', 'groupDescription': 'Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9396', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.202', 'groupDescription': 'Anxiety Somatic, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0283', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.195', 'groupDescription': 'Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1794', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.189', 'groupDescription': 'Anxiety Somatic, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1091', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.188', 'groupDescription': 'Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7921', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.182', 'groupDescription': 'Anxiety Somatic, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.166', 'groupDescription': 'Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0300', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.161', 'groupDescription': 'Anxiety Somatic, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '-0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2266', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.178', 'groupDescription': 'Anxiety Somatic, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '-0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.181', 'groupDescription': 'Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0555', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.176', 'groupDescription': 'Anxiety Somatic, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.58', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.176', 'groupDescription': 'Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0775', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.171', 'groupDescription': 'Anxiety Somatic, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.67', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.190', 'groupDescription': 'Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0415', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Anxiety Somatic, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'groupDescription': 'Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6826', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.188', 'groupDescription': 'Anxiety Somatic, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0912', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.226', 'groupDescription': 'Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3988', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.218', 'groupDescription': 'Anxiety Somatic, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.46', 'ciLowerLimit': '-0.91', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.231', 'groupDescription': 'Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.220', 'groupDescription': 'Anxiety Somatic, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.222', 'groupDescription': 'Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3785', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.218', 'groupDescription': 'Anxiety Somatic, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9609', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9183', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0710', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.149', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2607', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.143', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3461', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.153', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0919', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7554', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0150', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '-0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.166', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0482', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '-0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.163', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1182', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.156', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.55', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1379', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-0.71', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3100', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.140', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '-0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.148', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0223', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.143', 'groupDescription': 'Somatic Symptoms GI, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0276', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.166', 'groupDescription': 'Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8516', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.161', 'groupDescription': 'Somatic Symptoms GI, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1669', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.186', 'groupDescription': 'Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4935', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'groupDescription': 'Somatic Symptoms GI, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '-0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.197', 'groupDescription': 'Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2683', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.188', 'groupDescription': 'Somatic Symptoms GI, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0531', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.165', 'groupDescription': 'Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5609', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'groupDescription': 'Somatic Symptoms GI, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6779', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.123', 'groupDescription': 'Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4559', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.119', 'groupDescription': 'Somatic Symptoms General, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2254', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'groupDescription': 'Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6437', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Somatic Symptoms General, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6678', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'groupDescription': 'Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9321', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.129', 'groupDescription': 'Somatic Symptoms General, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9778', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9307', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Somatic Symptoms General, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6791', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7769', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.38', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.167', 'groupDescription': 'Somatic Symptoms General, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7206', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.163', 'groupDescription': 'Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3549', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.156', 'groupDescription': 'Somatic Symptoms General, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0231', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.164', 'groupDescription': 'Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1450', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'groupDescription': 'Somatic Symptoms General, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0855', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3068', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Somatic Symptoms General, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.45', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '-0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.164', 'groupDescription': 'Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2174', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'groupDescription': 'Somatic Symptoms General, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.174', 'groupDescription': 'Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9587', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.170', 'groupDescription': 'Somatic Symptoms General, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1690', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.203', 'groupDescription': 'Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7919', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.197', 'groupDescription': 'Somatic Symptoms General, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0192', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.205', 'groupDescription': 'Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3887', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.196', 'groupDescription': 'Somatic Symptoms General, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0719', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.189', 'groupDescription': 'Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1195', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Somatic Symptoms General, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9552', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.079', 'groupDescription': 'Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0384', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.076', 'groupDescription': 'Genital Symptoms, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2582', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.097', 'groupDescription': 'Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1511', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.094', 'groupDescription': 'Genital Symptoms, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4631', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.126', 'groupDescription': 'Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4628', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.123', 'groupDescription': 'Genital Symptoms, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.110', 'groupDescription': 'Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1121', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.107', 'groupDescription': 'Genital Symptoms, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'groupDescription': 'Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4071', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.141', 'groupDescription': 'Genital Symptoms, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0573', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.145', 'groupDescription': 'Genital Symptoms, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4842', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.156', 'groupDescription': 'Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0692', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Genital Symptoms, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.157', 'groupDescription': 'Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0354', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.154', 'groupDescription': 'Genital Symptoms, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.156', 'groupDescription': 'Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0099', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '-0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Genital Symptoms, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2174', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.164', 'groupDescription': 'Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0820', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.161', 'groupDescription': 'Genital Symptoms, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.194', 'groupDescription': 'Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0718', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.189', 'groupDescription': 'Genital Symptoms, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.64', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.212', 'groupDescription': 'Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3533', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.202', 'groupDescription': 'Genital Symptoms, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4514', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.193', 'groupDescription': 'Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4907', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.191', 'groupDescription': 'Genital Symptoms, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6949', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4670', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'groupDescription': 'Hypochondriasis, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.07', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.160', 'groupDescription': 'Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9272', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.156', 'groupDescription': 'Hypochondriasis, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1395', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.164', 'groupDescription': 'Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2601', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.159', 'groupDescription': 'Hypochondriasis, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'groupDescription': 'Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4622', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.153', 'groupDescription': 'Hypochondriasis, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2858', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5369', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Hypochondriasis, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1510', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5107', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.146', 'groupDescription': 'Hypochondriasis, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3301', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.151', 'groupDescription': 'Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5139', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'groupDescription': 'Hypochondriasis, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.144', 'groupDescription': 'Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4649', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.140', 'groupDescription': 'Hypochondriasis, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6926', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.141', 'groupDescription': 'Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7260', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.137', 'groupDescription': 'Hypochondriasis, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1486', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.136', 'groupDescription': 'Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4800', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.133', 'groupDescription': 'Hypochondriasis, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7792', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.177', 'groupDescription': 'Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8644', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.171', 'groupDescription': 'Hypochondriasis, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7994', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.158', 'groupDescription': 'Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0811', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.152', 'groupDescription': 'Hypochondriasis, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6978', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.144', 'groupDescription': 'Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9749', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.141', 'groupDescription': 'Hypochondriasis, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.081', 'groupDescription': 'Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1901', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.079', 'groupDescription': 'Loss of Weight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.073', 'groupDescription': 'Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2715', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.071', 'groupDescription': 'Loss of Weight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5421', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.086', 'groupDescription': 'Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7215', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.083', 'groupDescription': 'Loss of Weight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2246', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.098', 'groupDescription': 'Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9671', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.096', 'groupDescription': 'Loss of Weight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6527', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.121', 'groupDescription': 'Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1647', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.118', 'groupDescription': 'Loss of Weight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.110', 'groupDescription': 'Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6333', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.107', 'groupDescription': 'Loss of Weight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5238', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.120', 'groupDescription': 'Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0782', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.02', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.117', 'groupDescription': 'Loss of Weight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2346', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.138', 'groupDescription': 'Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0631', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.134', 'groupDescription': 'Loss of Weight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6274', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.131', 'groupDescription': 'Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3589', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.128', 'groupDescription': 'Loss of Weight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7604', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.187', 'groupDescription': 'Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1106', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.185', 'groupDescription': 'Loss of Weight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9776', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.222', 'groupDescription': 'Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3239', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.22', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.217', 'groupDescription': 'Loss of Weight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6736', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.238', 'groupDescription': 'Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6136', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.231', 'groupDescription': 'Loss of Weight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.195', 'groupDescription': 'Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2185', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.194', 'groupDescription': 'Loss of Weight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6191', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6169', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 2: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9911', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3360', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 4: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9638', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1610', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 8: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0599', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '0.00', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 12: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3916', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9602', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 24: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9676', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.055', 'groupDescription': 'Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6397', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 36: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3400', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3472', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 48: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9160', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5948', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 60: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3755', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9752', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Hour 72: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6379', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.053', 'groupDescription': 'Insight, Change at Day 7: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.061', 'groupDescription': 'Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3492', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.059', 'groupDescription': 'Insight, Change at Day 14: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.062', 'groupDescription': 'Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8163', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.059', 'groupDescription': 'Insight, Change at Day 21: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2825', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.055', 'groupDescription': 'Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1603', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.054', 'groupDescription': 'Insight, Change at Day 30: MMRM was used for analysis. The change from baseline in HAM-D individual item at each visit was the dependent variable. Treatment, baseline HAM-D individual item score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms were explanatory variables included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Hour 2, Hour 4, Hour 8, Hour 12, Hour 24, Hour 36, Hour 48, Hour 60, Hour 72 and Days 7, 14, 21 and 30', 'description': 'The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-19.98', 'spread': '1.688', 'groupId': 'OG000'}, {'value': '-26.84', 'spread': '1.822', 'groupId': 'OG001'}, {'value': '-24.19', 'spread': '1.797', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-19.01', 'spread': '1.865', 'groupId': 'OG000'}, {'value': '-23.31', 'spread': '2.001', 'groupId': 'OG001'}, {'value': '-20.32', 'spread': '1.982', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-19.43', 'spread': '1.917', 'groupId': 'OG000'}, {'value': '-25.06', 'spread': '2.091', 'groupId': 'OG001'}, {'value': '-23.02', 'spread': '2.080', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.85', 'ciLowerLimit': '-11.64', 'ciUpperLimit': '-2.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.414', 'groupDescription': 'Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0763', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.20', 'ciLowerLimit': '-8.86', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.350', 'groupDescription': 'Change at Hour 60: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.30', 'ciLowerLimit': '-9.60', 'ciUpperLimit': '0.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.673', 'groupDescription': 'Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6167', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.31', 'ciLowerLimit': '-6.50', 'ciUpperLimit': '3.87', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.618', 'groupDescription': 'Change at Day 7: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0447', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.64', 'ciLowerLimit': '-11.14', 'ciUpperLimit': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.777', 'groupDescription': 'Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1908', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.59', 'ciLowerLimit': '-8.99', 'ciUpperLimit': '1.81', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.726', 'groupDescription': 'Change at Day 30: MMRM was used for analysis. The change from baseline in MADRS total score at each visit was the dependent variable. Treatment, baseline MADRS total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Hour 60, Days 7 and 30', 'description': 'The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}, {'value': '82.1', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}, {'value': '64.1', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '52.4', 'groupId': 'OG000'}, {'value': '80.0', 'groupId': 'OG001'}, {'value': '72.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0131', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '1.3', 'ciUpperLimit': '11.7', 'groupDescription': 'Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0095', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '1.4', 'ciUpperLimit': '11.6', 'groupDescription': 'Hour 60: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0323', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '1.1', 'ciUpperLimit': '7.5', 'groupDescription': 'Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0931', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '0.9', 'ciUpperLimit': '5.3', 'groupDescription': 'Day 7: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0139', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '1.3', 'ciUpperLimit': '10.0', 'groupDescription': 'Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0460', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '1.0', 'ciUpperLimit': '6.9', 'groupDescription': 'Day 30: GEE method was used for analysis. CGI-I response at each visit was the dependent variable. Treatment, baseline CGI-S score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model.', 'statisticalMethod': 'GEE method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Hour 60, Days 7 and 30', 'description': "The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Hour 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.95', 'spread': '1.012', 'groupId': 'OG000'}, {'value': '-8.08', 'spread': '1.095', 'groupId': 'OG001'}, {'value': '-7.99', 'spread': '1.087', 'groupId': 'OG002'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.57', 'spread': '0.947', 'groupId': 'OG000'}, {'value': '-9.13', 'spread': '1.025', 'groupId': 'OG001'}, {'value': '-6.32', 'spread': '1.034', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.60', 'spread': '1.081', 'groupId': 'OG000'}, {'value': '-9.20', 'spread': '1.210', 'groupId': 'OG001'}, {'value': '-8.71', 'spread': '1.191', 'groupId': 'OG002'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.47', 'spread': '1.093', 'groupId': 'OG000'}, {'value': '-8.53', 'spread': '1.224', 'groupId': 'OG001'}, {'value': '-9.22', 'spread': '1.199', 'groupId': 'OG002'}]}]}, {'title': 'Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.70', 'spread': '1.023', 'groupId': 'OG000'}, {'value': '-9.72', 'spread': '1.129', 'groupId': 'OG001'}, {'value': '-9.15', 'spread': '1.135', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4389', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-4.01', 'ciUpperLimit': '1.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.454', 'groupDescription': 'Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4645', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-3.88', 'ciUpperLimit': '1.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.427', 'groupDescription': 'Change at Hour 60: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0622', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.56', 'ciLowerLimit': '-5.24', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.356', 'groupDescription': 'Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8495', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-2.40', 'ciUpperLimit': '2.91', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.338', 'groupDescription': 'Change at Day 7: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7063', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-3.75', 'ciUpperLimit': '2.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.590', 'groupDescription': 'Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9434', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-3.19', 'ciUpperLimit': '2.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.552', 'groupDescription': 'Change at Day 14: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-3.25', 'ciUpperLimit': '3.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.608', 'groupDescription': 'Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6307', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-3.86', 'ciUpperLimit': '2.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.566', 'groupDescription': 'Change at Day 21: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1767', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.02', 'ciLowerLimit': '-4.97', 'ciUpperLimit': '0.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.488', 'groupDescription': 'Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3236', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.46', 'ciLowerLimit': '-4.37', 'ciUpperLimit': '1.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.468', 'groupDescription': 'Change at Day 30: MMRM was used for the analysis. The change from baseline in GAD-7 total score at each visit was the dependent variable. Treatment, baseline GAD-7 total score, pooled center, baseline antidepressant use, visit time point, and visit time point-by-treatment interaction terms as explanatory variables were included in the model. All explanatory variables including pooled center were treated as fixed effects.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Hour 60, Days 7, 14, 21 and 30', 'description': 'The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = "not at all sure," 1 = "several days," 2 = "over half the days," and 3 = "nearly every day" to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}, {'value': '53.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 37 days.', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent AE (TEAE) is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set included all randomized participants who started the study drug infusion.'}, {'type': 'SECONDARY', 'title': 'Time to Change in Antidepressant Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'OG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'OG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'classes': [{'title': 'Time to first start/increase in dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '22'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '34'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '29'}]}]}, {'title': 'Time to first stop/decrease in dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '29'}, {'value': '19', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '19'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 37 days.', 'description': 'The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment. Number analyzed is the number of participants with data available for analysis at the given time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group.'}, {'id': 'FG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'FG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'Participants Who Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Randomized but not dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 32 centers in United States from 01 August 2016 to 19 October 2017.', 'preAssignmentDetails': 'A total of 138 participants were randomized into the study to receive either placebo or SAGE-547. Forty-three received placebo, and 79 received SAGE-547.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 μg/kg/h or 90 μg/kg/h group.'}, {'id': 'BG001', 'title': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).'}, {'id': 'BG002', 'title': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.2', 'spread': '6.13', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '6.46', 'groupId': 'BG001'}, {'value': '27.5', 'spread': '6.05', 'groupId': 'BG002'}, {'value': '27.4', 'spread': '6.16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian & Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latina', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latina', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hamilton Rating Scale for Depression (HAM-D) Total Score', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '2.54', 'groupId': 'BG000'}, {'value': '29.0', 'spread': '2.70', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '2.47', 'groupId': 'BG002'}, {'value': '28.7', 'spread': '2.55', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who started study drug infusion, had a valid baseline HAM-D assessment and at least one post-baseline HAM-D assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-16', 'size': 19415494, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-11T10:39', 'hasProtocol': True}, {'date': '2017-10-27', 'size': 1242338, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-11T10:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'dispFirstSubmitDate': '2018-09-06', 'completionDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2016-10-20', 'dispFirstSubmitQcDate': '2018-09-06', 'resultsFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2016-10-20', 'dispFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2019-05-22', 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline at 60 Hours in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score', 'timeFrame': 'Baseline, Hour 60', 'description': 'The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in HAM-D Total Score at Day 30', 'timeFrame': 'Baseline, Day 30', 'description': 'The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.'}, {'measure': 'Change From Baseline in HAM-D Total Score', 'timeFrame': 'Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14, and 21', 'description': 'The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.'}, {'measure': 'Percentage of Participants With HAM-D Response', 'timeFrame': 'Hour 60, Days 7 and 30', 'description': 'The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.'}, {'measure': 'Percentage of Participants With HAM-D Remission', 'timeFrame': 'Hour 60, Days 7 and 30', 'description': 'The HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.'}, {'measure': 'Change From Baseline in HAM-D Bech 6 Subscale', 'timeFrame': 'Baseline, Hour 60, Days 7 and 30', 'description': 'The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.'}, {'measure': 'Change From Baseline in HAM-D Individual Item Scores', 'timeFrame': 'Baseline, Hour 2, Hour 4, Hour 8, Hour 12, Hour 24, Hour 36, Hour 48, Hour 60, Hour 72 and Days 7, 14, 21 and 30', 'description': 'The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.'}, {'measure': 'Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score', 'timeFrame': 'Baseline, Hour 60, Days 7 and 30', 'description': 'The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.'}, {'measure': 'Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response', 'timeFrame': 'Hour 60, Days 7 and 30', 'description': "The CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved)."}, {'measure': 'Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score', 'timeFrame': 'Baseline, Hour 60, Days 7, 14, 21 and 30', 'description': 'The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = "not at all sure," 1 = "several days," 2 = "over half the days," and 3 = "nearly every day" to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.'}, {'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'Up to approximately 37 days.', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent AE (TEAE) is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.'}, {'measure': 'Time to Change in Antidepressant Medication', 'timeFrame': 'Up to approximately 37 days.', 'description': 'The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Severe Postpartum Depression', 'SAGE-547'], 'conditions': ['Postpartum Depression']}, 'referencesModule': {'references': [{'pmid': '33181049', 'type': 'DERIVED', 'citation': 'Gerbasi ME, Meltzer-Brody S, Acaster S, Fridman M, Bonthapally V, Hodgkins P, Kanes SJ, Eldar-Lissai A. Brexanolone in Postpartum Depression: Post Hoc Analyses to Help Inform Clinical Decision-Making. J Womens Health (Larchmt). 2021 Mar;30(3):385-392. doi: 10.1089/jwh.2020.8483. Epub 2020 Nov 12.'}, {'pmid': '30177236', 'type': 'DERIVED', 'citation': 'Meltzer-Brody S, Colquhoun H, Riesenberg R, Epperson CN, Deligiannidis KM, Rubinow DR, Li H, Sankoh AJ, Clemson C, Schacterle A, Jonas J, Kanes S. Brexanolone injection in post-partum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet. 2018 Sep 22;392(10152):1058-1070. doi: 10.1016/S0140-6736(18)31551-4. Epub 2018 Aug 31.'}], 'seeAlsoLinks': [{'url': 'http://www.sagerx.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female participants with postpartum depression defined as those who a major depressive episode that began no earlier than the third trimester and no later than the first four weeks following delivery, as diagnosed by Structured Clinical Interview Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition Axis I Disorders (SCID-I), a Hamilton Rating Scale for Depression (HAM-D) total score of ≥26 at screening and Day 1 (prior to dosing), and who were ≤6 months postpartum at screening.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Participants must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s) from just prior to receiving study drug through nine days (Day 12) after the end of the infusion\n* Participants had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)\n* Participant had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing)\n* Participant was ≤6 months postpartum at screening\n* Participant was amenable to IV therapy\n\nKey Exclusion Criteria:\n\n* Active psychosis\n* Attempted suicide associated with index case of postpartum depression\n* Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.\n\nNote: Other protocol-defined inclusion/exclusion criteria applied.'}, 'identificationModule': {'nctId': 'NCT02942004', 'briefTitle': 'A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Supernus Pharmaceuticals, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects With Severe Postpartum Depression and Adult Female Subjects With Moderate Postpartum Depression', 'orgStudyIdInfo': {'id': '547-PPD-202 B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received infusion rates equivalent to either the 60 micrograms per kilogram per hour (μg/kg/h) or 90 μg/kg/h group.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SAGE-547 60 μg/kg/h', 'description': 'Participants received a 4-hour titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 56 hours), followed by a taper to 30 μg/kg/h (56 to 60 hours).', 'interventionNames': ['Drug: SAGE-547 60 μg/kg/h']}, {'type': 'EXPERIMENTAL', 'label': 'SAGE-547 90 μg/kg/h', 'description': 'Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).', 'interventionNames': ['Drug: SAGE-547 90 μg/kg/h']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.', 'armGroupLabels': ['Placebo']}, {'name': 'SAGE-547 60 μg/kg/h', 'type': 'DRUG', 'description': 'Intravenous infusion of SAGE-547.', 'armGroupLabels': ['SAGE-547 60 μg/kg/h']}, {'name': 'SAGE-547 90 μg/kg/h', 'type': 'DRUG', 'description': 'Intravenous infusion of SAGE-547.', 'armGroupLabels': ['SAGE-547 90 μg/kg/h']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85226', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '91945', 'city': 'Lemon Grove', 'state': 'California', 'country': 'United States', 'facility': 'Sage Investigational Site', 'geoPoint': {'lat': 32.74255, 'lon': -117.03142}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Sage Investigational 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