Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-01 @ 5:05 PM
Study NCT ID:
NCT00958568
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2009-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Relapse Prevention of Treatment-Resistant Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'Hong Kong', 'Philippines']}, 'conditionBrowseModule': {'meshes': [{'id': 'D061218', 'term': 'Depressive Disorder, Treatment-Resistant'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492572', 'term': 'olanzapine-fluoxetine combination'}, {'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'OFC (SPII)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.', 'otherNumAtRisk': 892, 'otherNumAffected': 606, 'seriousNumAtRisk': 892, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'OFC (SPIII)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.', 'otherNumAtRisk': 655, 'otherNumAffected': 348, 'seriousNumAtRisk': 655, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.', 'otherNumAtRisk': 221, 'otherNumAffected': 100, 'seriousNumAtRisk': 221, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).', 'otherNumAtRisk': 223, 'otherNumAffected': 105, 'seriousNumAtRisk': 223, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 129, 'numAffected': 125}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 74, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 40, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 22, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood prolactin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 155, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 60, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased 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892, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 129, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 31, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 76, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 55, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 60, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 24, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 66, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 82, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 26, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Prostatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Metastatic neoplasm', 'notes': 'Event resulted in death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 892, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 655, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 221, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Relapse by Any Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': '10.0', 'comment': 'Not calculable due to few participants reaching the time-to-event endpoint of relapse at study completion.', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': 'NA'}, {'value': 'NA', 'spread': '5.9', 'comment': 'Not calculable due to few participants reaching the time-to-event endpoint of relapse at study completion.', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'groupDescription': 'Power estimate assumes approximately 1230 participants enter SPII. With a 60% drop-out/disqualification rate in SPII, then 492 participants enter SPIII. If 26% of participants drop out during SPIII, then 364 participants enter SPIV. Assuming 20% drop-out rate, 25% relapse rate on OFC and 40% relapse rate for fluoxetine (hazard ratio = 0.56), the log-rank test is 80% powered to detect a difference at a 2-sided 0.05 level. A total of 95 relapse events during SPIV should satisfy these assumptions.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included in the time to event analyses. The numbers of participants censored are 186 and 152 for OFC and Flu groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Relapse by Any Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '31.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Relapse is defined as meeting any of the following criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000'}, {'value': '28.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.713', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '28.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Relapse rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': '10.4', 'comment': 'Not calculable due to few participants reaching the time-to-event endpoint of relapse at study completion.', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': 'NA'}, {'value': 'NA', 'spread': '6.2', 'comment': 'Not calculable due to few participants reaching the time-to-event endpoint of relapse at study completion.', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Those who did not relapse were "censored" at their last observation.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included in the time to event analyses. The numbers of participants censored are 190 and 160 for OFC and Flu groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Time to Relapse as Measured by Hospitalization for Depression or Suicidality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': '29.9', 'comment': 'Not calculable due to few participants reaching the time-to-event endpoint of relapse at study completion.', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': 'NA'}, {'value': 'NA', 'spread': '4.3', 'comment': 'Not calculable due to few participants reaching the time-to-event endpoint of relapse at study completion.', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.831', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Those who did not relapse were "censored" at their last observation.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included in the time to event analyses. The numbers of participants censored are 217 and 220 for OFC and Flu groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': '11.8', 'comment': 'Not calculable due to few participants reaching the time-to-event endpoint of relapse at study completion.', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': 'NA'}, {'value': 'NA', 'spread': '5.3', 'comment': 'Not calculable due to few participants reaching the time-to-event endpoint of relapse at study completion.', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants are included in the time to event analyses. The numbers of participants censored are 197 and 160 for OFC and Flu groups, respectively.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '892', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPII-Wk 0-8, Acute Open-label)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 0 to Week 8', 'description': 'A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who entered open-label acute treatment phase (SPII).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIII)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8 to Week 20', 'description': 'A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who entered open-label stabilization treatment phase (SPIII).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Remission at Any Point During Stabilization Treatment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '655', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIII)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8 to Week 20', 'description': 'Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who entered open-label stabilization treatment phase (SPIII).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Maintaining Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}, {'value': '78.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Remission rates were analyzed using the Cochran-Mantel-Haenszel test adjusting for country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Mixed-Effects Model Repeated Measures (MMRM) Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.06', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '4.97', 'spread': '0.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.91', 'ciLowerLimit': '-4.46', 'ciUpperLimit': '-1.36', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.78', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Last Observation Carried Forward (LOCF) Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '6.84', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.82', 'ciLowerLimit': '-5.39', 'ciUpperLimit': '-2.24', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment and country.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), up to Week 47', 'description': 'The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) MADRS measurements. LOCF principle was used.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Clinical Global Impressions - Severity (CGI-S) of Depression Using Mixed-Effects Model Repeated Measures (MMRM) Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '-0.12', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) CGI-S measurements.'}, {'type': 'SECONDARY', 'title': 'Resource Utilization - Average Number of Hours Worked for Pay Per Week at Week 47', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '37.49', 'spread': '16.95', 'groupId': 'OG000'}, {'value': '37.76', 'spread': '14.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 47', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who worked for pay at Week 47.'}, {'type': 'SECONDARY', 'title': 'Resource Utilization (Number of Psychiatric Visits, Number of Emergency Room or Equivalent Facility Visits for Psychiatric Illness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'title': 'Psychiatric visits (n=136, 113)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '1.52', 'groupId': 'OG001'}]}]}, {'title': 'Emergency room or equivalent facility visits', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Resource utilization is defined as the average number of psychiatric visits and number of emergency room or equivalent facility visits for psychiatric illness.', 'unitOfMeasure': 'visits per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who provided information of psychiatric visits and emergency room or equivalent facility visits for psychiatric illness from Week 21 to Week 47.'}, {'type': 'SECONDARY', 'title': 'Change From Week 20 to Week 47 Endpoint in the Sheehan Disability Scale (SDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.30', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '0.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.94', 'ciLowerLimit': '-3.36', 'ciUpperLimit': '-0.53', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.72', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment and country.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), up to Week 47', 'description': "The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work or school (Item 1), social (Item 2), and family life and home responsibilities (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) SDS score measurements. Last observation carried forward (LOCF) principle was used.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent Akathisia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Barnes Akathisia Scale (BAS) rates observable, restless movements of drug-induced akathisia as well as the subjective awareness of restlessness and any distress associated with the akathisia. It consists of 4 items. 3 items (objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness) rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. Item 4 (global clinical assessment of Akathisia) is derived from the responses on Items 1-3 rated on a 6-point scale, with 0 being absence and 5 being extreme Akathisia. Treatment emergent akathisia is defined as a global clinical assessment score on BAS \\<2 at baseline (Week 20) and a global clinical assessment score on BAS ≥2 post-baseline (Weeks 21-47).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) BAS measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent Parkinsonism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.248', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Simpson-Angus Scale is used to measure Parkinsonian-type symptoms in participants exposed to neuroleptics. The scale consists of 10 items, each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items and ranges from 0-40 with higher scores indicating worse conditions. Treatment emergent parkinsonism is defined as total score ≤3 of items 1 through 10 of the Simpson-Angus scale at baseline (Week 20) and a total score \\>3 of items 1 through 10 post-baseline (Weeks 21-47).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) Simpson-Angus Scale measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent Dyskinesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Abnormal Involuntary Movement Scale (AIMS) is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of the participants. Treatment emergent dyskinesia is defined as a score ≥3 on any one of the AIMS items 1-7 post-baseline (Weeks 21-47) or scores ≥2 on any two of the AIMS items 1-7 post-baseline (Weeks 21-47) among participants without either criteria at baseline (Week 20).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) AIMS measurements.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Fasting Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.65', 'spread': '3.24', 'groupId': 'OG000'}, {'value': '-1.74', 'spread': '3.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.91', 'ciLowerLimit': '-9.71', 'ciUpperLimit': '7.89', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.47', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'milligrams/deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent High Fasting Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'title': 'Borderline to High (n= 75, 83)', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}]}]}, {'title': 'Normal to Borderline (n=47, 59)', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}, {'title': 'Normal to High (n=47, 59)', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '3.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.352', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Borderline to High fasting total cholesterol: ≥200 milligrams/deciliter (mg/dL) and \\<240 mg/dL at baseline and ≥240 mg/dL any time post baseline; Normal to Borderline fasting total cholesterol: \\<200 mg/dL at baseline, ≥200 mg/dL and \\<240 mg/dL any time post baseline; Normal to High fasting total cholesterol: \\<200 mg/dL at baseline and ≥240 mg/dL any time post baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had borderline or normal cholesterol level at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) cholesterol measurements.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Fasting Low-Density Lipoprotein (LDL) Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.72', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '3.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.703', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.57', 'ciLowerLimit': '-9.69', 'ciUpperLimit': '6.54', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.12', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'milligrams/deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent High Fasting Low-Density Lipoprotein (LDL) Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'title': 'Borderline to High (n= 115, 134)', 'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}]}]}, {'title': 'Normal to Borderline (n=22, 26)', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}]}]}, {'title': 'Normal to High (n=22, 26)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.139', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.746', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Borderline to High fasting LDL cholesterol: ≥100 milligrams/deciliter (mg/dL) and \\<160 mg/dL at baseline and ≥160 mg/dL any time post baseline; Normal to Borderline fasting LDL cholesterol: \\<100 mg/dL at baseline, ≥100 mg/dL and \\<160 mg/dL any time post baseline; Normal to High fasting LDL cholesterol: \\<100 mg/dL at baseline and ≥160 mg/dL any time post baseline.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had borderline or normal LDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) LDL cholesterol measurements.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Fasting High-Density Lipoprotein (HDL) Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.71', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.73', 'ciLowerLimit': '-5.99', 'ciUpperLimit': '-1.47', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.15', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'milligrams/deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent Low Fasting High-Density Lipoprotein (HDL) Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'groupId': 'OG000'}, {'value': '25.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Normal to Low fasting HDL cholesterol is ≥40 milligrams/deciliter (mg/dL) at baseline and \\<40 mg/dL anytime post baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had normal HDL cholesterol value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) HDL cholesterol measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent Hepatic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Participants with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\<=3 times the upper limit of normal (ULN) at baseline, with ALT or AST \\>=3 times the ULN post-baseline and total bilirubin \\>=2 times ULN at the same time are considered having treatment-emergent hepatic events.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and post-baseline (Weeks 21-47) hepatic function measurements.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Fasting Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.24', 'spread': '5.70', 'groupId': 'OG000'}, {'value': '-21.51', 'spread': '6.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.27', 'ciLowerLimit': '-1.72', 'ciUpperLimit': '28.26', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.62', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'milligrams/deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglycerides measurement.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent High Fasting Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'title': 'Borderline to High (n=47, 41)', 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}, {'value': '26.8', 'groupId': 'OG001'}]}]}, {'title': 'Normal to Borderline (n= 68, 74)', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Normal to High (n=68, 74)', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Borderline to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal to Borderline. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Borderline to High fasting triglycerides: ≥150 milligrams/deciliter (mg/dL) and \\<200 mg/dL at baseline and ≥200 mg/dL any time post baseline; Normal to Borderline fasting triglycerides: \\<150 mg/dL at baseline, ≥150 mg/dL and \\<200 mg/dL any time post baseline; Normal to High fasting triglycerides: \\<150 mg/dL at baseline and ≥200 mg/dL any time post baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had borderline or normal triglycerides value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) triglyceride measurements.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.67', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '1.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.89', 'ciLowerLimit': '2.22', 'ciUpperLimit': '9.56', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.87', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'milligrams/deciliter (mg/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Treatment-Emergent High Fasting Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'title': 'Impaired to High (n=98, 97)', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Normal to High (n=90, 96)', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000'}, {'value': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'Normal to Impaired (n=90, 96)', 'categories': [{'measurements': [{'value': '35.6', 'groupId': 'OG000'}, {'value': '28.1', 'groupId': 'OG001'}]}]}, {'title': 'Normal/Impaired to High (n= 188, 193)', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.344', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal to Impaired. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.072', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for Normal/Impaired to High. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Impaired to High fasting glucose: ≥100 milligrams/deciliter (mg/dL) and \\<126 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to High glucose: \\<100 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to Impaired fasting glucose is \\<100 mg/dL at baseline, ≥100 mg/dL and \\<126 mg/dL any time post baseline; Normal/Impaired to High fasting glucose: \\<126 mg/dL at baseline and ≥126 mg/dL any time post baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had impaired or normal glucose value at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) glucose measurements.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Week 20 to Week 47 in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-2.78', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.92', 'ciLowerLimit': '2.96', 'ciUpperLimit': '4.88', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) weight measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Week 20-to-Week 47 Endpoint Increase in Weight of at Least 7%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was 0.05.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 20 to Week 47', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had Week 20 and at least 1 post-baseline (Weeks 21-47) weight measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With Suicide-Related Thoughts and Behaviors', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal Behavior', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.392', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value is for suicidal ideation. The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) C-SSRS measurements.'}, {'type': 'SECONDARY', 'title': "Mean Change in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram", 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.12', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '1.60', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.421', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.57', 'ciLowerLimit': '-5.42', 'ciUpperLimit': '2.27', 'pValueComment': 'The test was run using an a priori 2-sided threshold for statistical significance of 0.05. No adjustments were made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The model adjusted for baseline (Week 20), treatment, country, visit, and treatment-by-visit interaction.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes baseline (Week 20), treatment, country, visit, and treatment by visit interaction.', 'unitOfMeasure': 'milliseconds (msec)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.'}, {'type': 'SECONDARY', 'title': "Percent of Participants With Treatment-Emergent Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram ≥500 Milliseconds (Msec)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Data presented are the percent of participants whose baseline corrected (for rate) cardiac QT interval \\<500 msec with post-baseline corrected (for rate) cardiac QT interval ≥500 msec.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had \\<500 msec QTc interval at baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.'}, {'type': 'SECONDARY', 'title': 'Percent of Participants With a 60 Milliseconds (Msec) Increase in Fridericia-Corrected (for Rate) Cardiac QT Interval (QTcF) on Electrocardiogram', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 47', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had baseline (Week 20) and at least 1 post-baseline (Weeks 21-47) electrocardiogram (ECG) measurements.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Kaplan-Meier Estimate of Percentage of Subjects Not Relapsing at Week 27 (Day 189)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.'}, {'id': 'OG001', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'classes': [{'title': 'Relapse-any criteria', 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000', 'lowerLimit': '77.6', 'upperLimit': '88.1'}, {'value': '66.5', 'groupId': 'OG001', 'lowerLimit': '59.6', 'upperLimit': '72.5'}]}]}, {'title': 'Relapse-MADRS score/CGI-S Depression Score', 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000', 'lowerLimit': '79.3', 'upperLimit': '89.6'}, {'value': '69.6', 'groupId': 'OG001', 'lowerLimit': '62.7', 'upperLimit': '75.5'}]}]}, {'title': 'Relapse-Hospitalization for depression/suicidality', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '99.1'}, {'value': '98.6', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '99.5'}]}]}, {'title': 'Relapse-Discontinued for lack efficacy/worsening', 'categories': [{'measurements': [{'value': '87.4', 'groupId': 'OG000', 'lowerLimit': '81.7', 'upperLimit': '91.4'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '75.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization (Week 20) to Week 27', 'description': 'Relapse is defined as meeting any of the following criteria (Relapse-any reason): 50% increase in MADRS score from randomization with concomitant CGI-S of Depression score increase to a score of 4 or more (MADRS score/CGI-S Depression Score); Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OFC (SPII )', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.'}, {'id': 'FG001', 'title': 'OFC (SPIII)', 'description': '6 mg Olanzapine and 25 mg Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.'}, {'id': 'FG002', 'title': 'OFC (SPIV)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.'}, {'id': 'FG003', 'title': 'Flu (SPIV)', 'description': 'Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).'}], 'periods': [{'title': 'SPII (Wk 0-8, Acute Open-label)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '892'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '655'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Response Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unknown, Not Otherwise Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'SPIII (Wk 9-20,Open-label Stabilization)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '655'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '444'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '211'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Stabilization Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Blinded Randomization Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Relapse Criteria Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Unknown, Not Otherwise Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'SPIV (Wk 21-47, DB Relapse Prevention)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '221'}, {'groupId': 'FG003', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '139'}, {'groupId': 'FG003', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '82'}, {'groupId': 'FG003', 'numSubjects': '106'}]}], 'dropWithdraws': [{'type': 'Relapse Criteria Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '63'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study consisted of 4 treatment phases: a screening phase (Study Period I \\[SPI\\]) of 3 to 14 days; a 6- to 8-week (wk) acute open-label treatment phase (SPII); a 12-week open-label stabilization treatment phase (SPIII); and a 27-week double-blind (DB) randomized relapse prevention treatment phase (SPIV).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '892', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OFC (SPII-Wk 0-8, Acute Open-label)', 'description': 'Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.38', 'spread': '11.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '591', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '301', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '167', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '725', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '115', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '634', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '533', 'groupId': 'BG000'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '29.12', 'spread': '7.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'N=892, data was not reported for 1 participant', 'unitOfMeasure': 'kilograms/square meter (kg/m²)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 892}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-17', 'studyFirstSubmitDate': '2009-08-12', 'resultsFirstSubmitDate': '2013-03-22', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-17', 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Kaplan-Meier Estimate of Percentage of Subjects Not Relapsing at Week 27 (Day 189)', 'timeFrame': 'Randomization (Week 20) to Week 27', 'description': 'Relapse is defined as meeting any of the following criteria (Relapse-any reason): 50% increase in MADRS score from randomization with concomitant CGI-S of Depression score increase to a score of 4 or more (MADRS score/CGI-S Depression Score); Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.'}], 'primaryOutcomes': [{'measure': 'Time to Relapse by Any Criteria', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Relapse defined as meeting any of these criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with a Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalized for depression or suicidality; Discontinued due to lack of efficacy/worsening of depression/suicidality. MADRS is a 10-item rating scale for depressive mood symptoms severity, items rated on 0-6 scale, with total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at discretion of investigator based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Relapse by Any Criteria', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Relapse is defined as meeting any of the following criteria: 50% increase in Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more; Hospitalization for depression or suicidality; Discontinuation due to lack of efficacy/worsening of depression/suicidality. MADRS is a rating scale for severity of depressive mood symptoms with 10 items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Lack of Efficacy/Worsening of depression was at the discretion of the investigator and based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.'}, {'measure': 'Percentage of Participants Who Relapse Based on Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill).'}, {'measure': 'Percentage of Participants Who Relapse as Measured by Hospitalization for Depression or Suicidality', 'timeFrame': 'Randomization (Week 20) to Week 47'}, {'measure': 'Percentage of Participants Who Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator.'}, {'measure': 'Time to Relapse Based on the Montgomery-Åsberg Depression Rating Scale (MADRS) Score With Concomitant Clinical Global Impressions-Severity (CGI-S) of Depression Score', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Relapse is defined as a 50% increase in the Montgomery-Asberg Depression Rating Scale (MADRS) score from randomization with concomitant Clinical Global Impressions-Severity (CGI-S) of Depression score increase to a score of 4 or more. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (the most extremely ill). Those who did not relapse were "censored" at their last observation.'}, {'measure': 'Time to Relapse as Measured by Hospitalization for Depression or Suicidality', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Those who did not relapse were "censored" at their last observation.'}, {'measure': 'Time to Relapse as Measured by Discontinuation Due to Lack of Efficacy/Worsening of Depression/Suicidality', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Lack of Efficacy/Worsening of depression was at the discretion of the investigator and was based on clinical observation. Suicidality is thoughts or actions of self-harm as determined by the investigator. Those who did not relapse were "censored" at their last observation.'}, {'measure': 'Percentage of Participants Responding to Treatment During Open-Label Acute Treatment Phase', 'timeFrame': 'Week 0 to Week 8', 'description': 'A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).'}, {'measure': 'Percentage of Participants Maintaining Response at Any Point During Stabilization Treatment Phase', 'timeFrame': 'Week 8 to Week 20', 'description': 'A 50% or greater improvement from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) and a Clinical Global Impressions-Severity (CGI-S) of Depression score ≤3 will be considered as response criteria met. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).'}, {'measure': 'Percentage of Participants Achieving Remission at Any Point During Stabilization Treatment Phase', 'timeFrame': 'Week 8 to Week 20', 'description': 'Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).'}, {'measure': 'Percentage of Participants Maintaining Remission', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Remission is defined as the Montgomery-Asberg Depression Rating Scale (MADRS) score ≤8. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).'}, {'measure': 'Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Mixed-Effects Model Repeated Measures (MMRM) Analysis', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': 'Mean Change From Week 20 to Week 47 in Montgomery-Asberg Depression Rating Scale (MADRS) Using Last Observation Carried Forward (LOCF) Analysis', 'timeFrame': 'Randomization (Week 20), up to Week 47', 'description': 'The MADRS has a 10-item checklist with items rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country.'}, {'measure': 'Mean Change From Week 20 to Week 47 in Clinical Global Impressions - Severity (CGI-S) of Depression Using Mixed-Effects Model Repeated Measures (MMRM) Analysis', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': 'Resource Utilization - Average Number of Hours Worked for Pay Per Week at Week 47', 'timeFrame': 'Week 47'}, {'measure': 'Resource Utilization (Number of Psychiatric Visits, Number of Emergency Room or Equivalent Facility Visits for Psychiatric Illness)', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Resource utilization is defined as the average number of psychiatric visits and number of emergency room or equivalent facility visits for psychiatric illness.'}, {'measure': 'Change From Week 20 to Week 47 Endpoint in the Sheehan Disability Scale (SDS)', 'timeFrame': 'Randomization (Week 20), up to Week 47', 'description': "The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work or school (Item 1), social (Item 2), and family life and home responsibilities (Item 3). Each item is measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total scores is the sum of the 3 items and range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. Least Squares (LS) Mean values were controlled for baseline (Week 20), treatment and country."}, {'measure': 'Percent of Participants With Treatment-Emergent Akathisia', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Barnes Akathisia Scale (BAS) rates observable, restless movements of drug-induced akathisia as well as the subjective awareness of restlessness and any distress associated with the akathisia. It consists of 4 items. 3 items (objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness) rated on a 4-point scale, with 0 being no akathisia and 3 being severe akathisia. Item 4 (global clinical assessment of Akathisia) is derived from the responses on Items 1-3 rated on a 6-point scale, with 0 being absence and 5 being extreme Akathisia. Treatment emergent akathisia is defined as a global clinical assessment score on BAS \\<2 at baseline (Week 20) and a global clinical assessment score on BAS ≥2 post-baseline (Weeks 21-47).'}, {'measure': 'Percent of Participants With Treatment-Emergent Parkinsonism', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Simpson-Angus Scale is used to measure Parkinsonian-type symptoms in participants exposed to neuroleptics. The scale consists of 10 items, each rated on a 5-point scale, with 0 meaning complete absence of the condition and 4 meaning the presence of the condition in extreme form. The total score is obtained by adding the items and ranges from 0-40 with higher scores indicating worse conditions. Treatment emergent parkinsonism is defined as total score ≤3 of items 1 through 10 of the Simpson-Angus scale at baseline (Week 20) and a total score \\>3 of items 1 through 10 post-baseline (Weeks 21-47).'}, {'measure': 'Percent of Participants With Treatment-Emergent Dyskinesia', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Abnormal Involuntary Movement Scale (AIMS) is a 12-item scale designed to record the occurrence of dyskinetic movements. Items 1 through 10 are rated on a 5-point scale, with 0 being no dyskinetic movements and 4 being severe dyskinetic movements. Items 11 and 12 are yes/no questions regarding the dental condition of the participants. Treatment emergent dyskinesia is defined as a score ≥3 on any one of the AIMS items 1-7 post-baseline (Weeks 21-47) or scores ≥2 on any two of the AIMS items 1-7 post-baseline (Weeks 21-47) among participants without either criteria at baseline (Week 20).'}, {'measure': 'Mean Change From Week 20 to Week 47 in Fasting Total Cholesterol', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': 'Percent of Participants With Treatment-Emergent High Fasting Total Cholesterol', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Borderline to High fasting total cholesterol: ≥200 milligrams/deciliter (mg/dL) and \\<240 mg/dL at baseline and ≥240 mg/dL any time post baseline; Normal to Borderline fasting total cholesterol: \\<200 mg/dL at baseline, ≥200 mg/dL and \\<240 mg/dL any time post baseline; Normal to High fasting total cholesterol: \\<200 mg/dL at baseline and ≥240 mg/dL any time post baseline.'}, {'measure': 'Mean Change From Week 20 to Week 47 in Fasting Low-Density Lipoprotein (LDL) Cholesterol', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': 'Percent of Participants With Treatment-Emergent High Fasting Low-Density Lipoprotein (LDL) Cholesterol', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Borderline to High fasting LDL cholesterol: ≥100 milligrams/deciliter (mg/dL) and \\<160 mg/dL at baseline and ≥160 mg/dL any time post baseline; Normal to Borderline fasting LDL cholesterol: \\<100 mg/dL at baseline, ≥100 mg/dL and \\<160 mg/dL any time post baseline; Normal to High fasting LDL cholesterol: \\<100 mg/dL at baseline and ≥160 mg/dL any time post baseline.'}, {'measure': 'Mean Change From Week 20 to Week 47 in Fasting High-Density Lipoprotein (HDL) Cholesterol', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': 'Percent of Participants With Treatment-Emergent Low Fasting High-Density Lipoprotein (HDL) Cholesterol', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Normal to Low fasting HDL cholesterol is ≥40 milligrams/deciliter (mg/dL) at baseline and \\<40 mg/dL anytime post baseline.'}, {'measure': 'Percent of Participants With Treatment-Emergent Hepatic Events', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Participants with alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\<=3 times the upper limit of normal (ULN) at baseline, with ALT or AST \\>=3 times the ULN post-baseline and total bilirubin \\>=2 times ULN at the same time are considered having treatment-emergent hepatic events.'}, {'measure': 'Mean Change From Week 20 to Week 47 in Fasting Triglycerides', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': 'Percent of Participants With Treatment-Emergent High Fasting Triglycerides', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Borderline to High fasting triglycerides: ≥150 milligrams/deciliter (mg/dL) and \\<200 mg/dL at baseline and ≥200 mg/dL any time post baseline; Normal to Borderline fasting triglycerides: \\<150 mg/dL at baseline, ≥150 mg/dL and \\<200 mg/dL any time post baseline; Normal to High fasting triglycerides: \\<150 mg/dL at baseline and ≥200 mg/dL any time post baseline.'}, {'measure': 'Mean Change From Week 20 to Week 47 in Fasting Glucose', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': 'Percent of Participants With Treatment-Emergent High Fasting Glucose', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Impaired to High fasting glucose: ≥100 milligrams/deciliter (mg/dL) and \\<126 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to High glucose: \\<100 mg/dL at baseline and ≥126 mg/dL any time post baseline; Normal to Impaired fasting glucose is \\<100 mg/dL at baseline, ≥100 mg/dL and \\<126 mg/dL any time post baseline; Normal/Impaired to High fasting glucose: \\<126 mg/dL at baseline and ≥126 mg/dL any time post baseline.'}, {'measure': 'Mean Change From Week 20 to Week 47 in Weight', 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Mixed-effects model repeated measures (MMRM) analysis was used to calculate Least Squares (LS) Mean and standard error (SE). LS Mean values were controlled for baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': 'Percent of Participants With Week 20-to-Week 47 Endpoint Increase in Weight of at Least 7%', 'timeFrame': 'Week 20 to Week 47'}, {'measure': 'Percent of Participants With Suicide-Related Thoughts and Behaviors', 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.'}, {'measure': "Mean Change in Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram", 'timeFrame': 'Randomization (Week 20), Week 47', 'description': 'Least Squares (LS) Mean values were obtained from a mixed model repeated measures (MMRM) analysis. Model includes baseline (Week 20), treatment, country, visit, and treatment by visit interaction.'}, {'measure': "Percent of Participants With Treatment-Emergent Corrected (for Rate) Cardiac QT Interval Using Fridericia's Formula (QTcF) on Electrocardiogram ≥500 Milliseconds (Msec)", 'timeFrame': 'Randomization (Week 20) to Week 47', 'description': 'Data presented are the percent of participants whose baseline corrected (for rate) cardiac QT interval \\<500 msec with post-baseline corrected (for rate) cardiac QT interval ≥500 msec.'}, {'measure': 'Percent of Participants With a 60 Milliseconds (Msec) Increase in Fridericia-Corrected (for Rate) Cardiac QT Interval (QTcF) on Electrocardiogram', 'timeFrame': 'Randomization (Week 20) to Week 47'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Treatment Resistant Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when used to treat patients with Treatment Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression when treated for a long time (up to 47 weeks) and to assess the quality of life during treatment.', 'detailedDescription': 'This is a multicenter, randomized, double-blind, active comparator-controlled, parallel study of participants with Treatment Resistant Depression (TRD), comparing the efficacy and safety of olanzapine and fluoxetine Combination (OFC) versus fluoxetine in relapse prevention of stabilized participants with TRD. The study will consist of 4 phases: a screening phase; a 6- to 8-week open-label acute treatment phase; a 10- to 12-week open-label stabilization phase; and a 27- to 29-week double-blind relapse prevention treatment phase. Participants who demonstrate response to open-label OFC during the acute treatment phase will continue into the stabilization phase. Participants who remain stable while receiving open-label OFC during this phase will be randomized to receive either OFC or fluoxetine during the double-blind relapse prevention phase. Investigators and participants will be blinded to the precise duration of the stabilization period, the definition of remission, and the criteria for entry into the relapse prevention phase; this information is described in a supplement given to Ethical Review Boards (ERBs) and regulatory authorities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have single or recurrent unipolar Major Depressive Disorder (MDD), without psychotic features by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR) clinical assessment, confirmed by the structured clinician Interview for DSM-IV Axis 1 disorders (SCID-I).\n* If female and of childbearing potential, test negative for pregnancy and agree to abstain from sexual activity or use a medically accepted means of contraception during the study. Use of any oral or injectable contraception must be initiated prior to receiving treatment.\n* Have 17-item Hamilton Depression (HAM-D) score greater than or equal to 18 at screening and the day treatment is due to be received for the first time.\n* Have treatment-resistant depression, as defined by having demonstrated failure to achieve satisfactory antidepressant response to adequate separate treatment courses of at least 2 different antidepressants within the current episode of MDD.\n\nExclusion Criteria:\n\n* Have a diagnosis of Parkinson's disease or related disorders.\n* Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Bipolar Disorder I or II, Delirium of any type, Dementia of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition.\n* Have current diagnosis of post-partum depression, MDD with atypical features, or MDD with a seasonal pattern as defined in the DSM-IV.\n* Have paranoid, schizoid, schizotypal, antisocial, and borderline personality disorders (Axis II) as a comorbid or primary diagnosis, based on DSM-IV criteria.\n* Have had psychotic symptoms within 1 month prior to Screening or demonstrate psychotic features at screening and on the day treatment is due to be assigned for the first time as determined by the investigator.\n* Have DSM-IV substance dependence/abuse or not willing to avoid use of the substance (not including dependence on nicotine or caffeine), as defined by the SCID-I, within the past 30 days.\n* Are actively suicidal in the judgment of the investigator.\n* Have had one or more seizures without a clear and resolved etiology.\n* Have leukopenia or history of leukopenia without a clear and resolved etiology, or known history of agranulocytosis during the participant's lifetime.\n* Have alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) values greater than or equal to 2 times the upper limit of normal (ULN) of the performing laboratory or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) values greater than or equal to 2 times the ULN or total bilirubin values greater than or equal to 1.5 times the ULN at any time during screening.\n* Have acute, serious, or unstable medical conditions.\n* Have any illness such that death is anticipated within 1 year or intensive care unit hospitalization for the illness is anticipated within 6 months.\n* Have elevated prolactin levels at screening.\n* Have Bazett's corrected QT interval (QTc) greater than 450 milliseconds (male) or greater than 470 milliseconds (female) at screening and when treatment is due to be received for the first time.\n* Have received electroconvulsive therapy (ECT) or vagus nerve stimulation (VNS) treatment within the current episode; have a history of failure to adequate treatment courses of ECT or VNS; or will require ECT or VNS at any time during study participation.\n* If receiving psychotherapy, light therapy, or both, are anticipated to require changes in frequency/intensity of treatment regimen or to cease treatment regimen over the duration of the study. Participants who are not receiving any of these therapies upon study entry may not begin any of these therapies during screening, or during any treatment phases of the study.\n* Have received previous treatment with clozapine.\n* Have used a monoamine oxidase inhibitor (MAOI) within 14 days prior to screening or are expected to need MAOI treatment at any time during this study through 5 weeks after the participant discontinues from the study."}, 'identificationModule': {'nctId': 'NCT00958568', 'briefTitle': 'A Study in Relapse Prevention of Treatment-Resistant Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Study to Assess the Long-Term Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Fluoxetine Only in the Relapse Prevention of Stabilized Patients With Treatment-Resistant Depression', 'orgStudyIdInfo': {'id': '12115'}, 'secondaryIdInfos': [{'id': 'H6P-MC-HDAY', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'CTRI/2009/091/000654', 'type': 'REGISTRY', 'domain': 'Clinical Trials Register India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olanzapine and Fluoxetine combination (OFC)', 'interventionNames': ['Drug: Olanzapine and Fluoxetine combination (OFC)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoxetine', 'interventionNames': ['Drug: Fluoxetine']}], 'interventions': [{'name': 'Olanzapine and Fluoxetine combination (OFC)', 'type': 'DRUG', 'otherNames': ['Symbyax', 'LY900000'], 'description': 'Open label acute phase: introductory dose for 4 days then 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks.\n\nOpen label stabilization phase: 6/25, 12/25, 6/50, 12/50 or 18/50 mg, oral, daily for 16-20 weeks.\n\nDouble blind relapse prevention phase: dose determined during stabilization phase at Week 17, oral, daily, for 27 weeks.', 'armGroupLabels': ['Olanzapine and Fluoxetine combination (OFC)']}, {'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['Prozac', 'LY1101440'], 'description': '25 or 50 mg/day fixed dosing for 27 weeks', 'armGroupLabels': ['Fluoxetine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91106', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '92595', 'city': 'Wildomar', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.59891, 'lon': -117.28004}}, {'zip': '06416', 'city': 'Cromwell', 'state': 'Connecticut', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.5951, 'lon': -72.64537}}, {'zip': '20016', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '47905', 'city': 'Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4167, 'lon': -86.87529}}, {'zip': '41042', 'city': 'Florence', 'state': 'Kentucky', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.99895, 'lon': -84.62661}}, {'zip': '21285', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21061', 'city': 'Glen Burnie', 'state': 'Maryland', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Florida', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '14330', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '64640', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '00731-7779', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.06046, 'lon': 28.98717}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}