Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05028569
Status:
TERMINATED
Last Update Posted:
2025-12-09
First Post:
2021-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.', 'description': 'Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).', 'eventGroups': [{'id': 'EG000', 'title': 'Screening/Baseline Phase', 'description': 'Participants with 6 to 14 migraine days and \\< 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study.', 'otherNumAtRisk': 775, 'deathsNumAtRisk': 775, 'otherNumAffected': 14, 'seriousNumAtRisk': 775, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.', 'otherNumAtRisk': 257, 'deathsNumAtRisk': 257, 'otherNumAffected': 21, 'seriousNumAtRisk': 257, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.', 'otherNumAtRisk': 256, 'deathsNumAtRisk': 256, 'otherNumAffected': 35, 'seriousNumAtRisk': 256, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.', 'otherNumAtRisk': 262, 'deathsNumAtRisk': 262, 'otherNumAffected': 22, 'seriousNumAtRisk': 262, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U', 'description': 'Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 19, 'seriousNumAtRisk': 217, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U', 'description': 'Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 18, 'seriousNumAtRisk': 227, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U', 'description': 'Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 14, 'seriousNumAtRisk': 223, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'IMMUNE THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'VESTIBULAR DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'PORTOSPLENOMESENTERIC VENOUS THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'STAPHYLOCOCCAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'TRAUMATIC HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'LIPOSARCOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'MIGRAINE WITH AURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'MYELOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COMPLETED SUICIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'BENIGN PROSTATIC HYPERPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'BREAST HYPERPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'LABILE BLOOD PRESSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 775, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 256, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 262, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 227, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'OG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'OG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'groupId': 'OG000', 'lowerLimit': '-3.55', 'upperLimit': '-2.46'}, {'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-3.65', 'upperLimit': '-2.57'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-3.51', 'upperLimit': '-2.43'}]}]}], 'analyses': [{'pValue': '=0.914', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.69', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'estimateComment': 'LS Mean Difference = BOTOX 195 U - Placebo', 'groupDescription': 'BOTOX 195 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly migraine days as covariate, included as a continuous variable rather than the binomial stratification variable. Subject/residual errors are random effects.'}, {'pValue': '=0.745', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '0.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'estimateComment': 'LS Mean Difference = BOTOX 155 U - Placebo', 'groupDescription': 'BOTOX 155 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly migraine days as covariate, included as a continuous variable rather than the binomial stratification variable. Subject/residual errors are random effects.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months 5-6', 'description': 'The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.', 'unitOfMeasure': 'monthly migraine days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}, {'value': '217', 'groupId': 'OG003'}, {'value': '225', 'groupId': 'OG004'}, {'value': '223', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'OG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'OG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}, {'id': 'OG003', 'title': 'Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U', 'description': 'Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.'}, {'id': 'OG004', 'title': 'Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U', 'description': 'Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.'}, {'id': 'OG005', 'title': 'Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U', 'description': 'Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '120', 'groupId': 'OG002'}, {'value': '76', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}]}]}, {'title': 'TESAE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Double-Blind Phase (Week 0-24); Open-Label Phase (Week 24-48)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set: all participants who received any amount of study treatment; included in the analysis according to the study treatment that they actually received (as treated).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Frequency of Monthly Headache Days Across Months 5 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'OG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'OG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-3.77', 'upperLimit': '-2.59'}, {'value': '-3.1', 'groupId': 'OG001', 'lowerLimit': '-3.71', 'upperLimit': '-2.54'}, {'value': '-2.9', 'groupId': 'OG002', 'lowerLimit': '-3.46', 'upperLimit': '-2.29'}]}]}], 'analyses': [{'pValue': '=0.414', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '1.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'estimateComment': 'LS Mean Difference = BOTOX 195 U - Placebo', 'groupDescription': 'BOTOX 195 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly headache days as covariate, included as a continuous variable. Subject/residual errors are random effects.'}, {'pValue': '=0.889', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '0.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.36', 'estimateComment': 'LS Mean Difference = BOTOX 155 U - Placebo', 'groupDescription': 'BOTOX 155 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with Baseline monthly headache days as covariate, included as a continuous variable. Subject/residual errors are random effects.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months 5-6', 'description': 'The frequency of monthly headache days across Months 5 and 6 is calculated by taking the 2-month average of monthly headache days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.', 'unitOfMeasure': 'monthly headache days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With ≥ 50% Reduction From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'OG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'OG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'groupId': 'OG000', 'lowerLimit': '38.35', 'upperLimit': '51.66'}, {'value': '46.2', 'groupId': 'OG001', 'lowerLimit': '39.64', 'upperLimit': '52.77'}, {'value': '47.1', 'groupId': 'OG002', 'lowerLimit': '40.50', 'upperLimit': '53.85'}]}]}], 'analyses': [{'pValue': '=0.451', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-7.08', 'ciUpperLimit': '11.46', 'estimateComment': 'Response Rate Difference = BOTOX 195 U - Placebo', 'groupDescription': 'BOTOX 195 U vs Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value is obtained from Logistic Regression. Model includes treatment (BOTOX 195 U, BOTOX 155 U, and placebo), country and strata of previous exposure to migraine prophylactic treatment as fixed effects, with the Baseline monthly migraine days as a covariate, included as a continuous variable. Subject and residual errors are random effects in this by visit logistic covariate analysis of variance (ANCOVA). Confidence intervals (Clopper-Pearson) are based on binomial-distribution assumptions.'}, {'pValue': '=0.762', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-7.94', 'ciUpperLimit': '10.40', 'estimateComment': 'Response Rate Difference = BOTOX 155 U - Placebo', 'groupDescription': 'BOTOX 155 U vs Placebo', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value is obtained from Logistic Regression. Model includes treatment (BOTOX 195 U, BOTOX 155 U, and placebo), country and strata of previous exposure to migraine prophylactic treatment as fixed effects, with the Baseline monthly migraine days as a covariate, included as a continuous variable. Subject and residual errors are random effects in this by visit logistic covariate analysis of variance (ANCOVA). Confidence intervals (Clopper-Pearson) are based on binomial-distribution assumptions.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Months 5-6', 'description': 'The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 2-month average of monthly migraine days over Months 5 and 6.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Frequency of Monthly Acute Headache Medication Days Across Months 5 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'OG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'OG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-2.47', 'upperLimit': '-1.47'}, {'value': '-1.9', 'groupId': 'OG001', 'lowerLimit': '-2.44', 'upperLimit': '-1.44'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-2.34', 'upperLimit': '-1.35'}]}]}], 'analyses': [{'pValue': '=0.686', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'estimateComment': 'LS Mean Difference = BOTOX 195 U - Placebo', 'groupDescription': 'BOTOX 195 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline monthly acute headache medication days as a covariate, included as a continuous variable. Subject and residual errors are random effects.'}, {'pValue': '=0.913', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'estimateComment': 'LS Mean Difference = BOTOX 155 U - Placebo', 'groupDescription': 'BOTOX 155 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline monthly acute headache medication days as a covariate, included as a continuous variable. Subject and residual errors are random effects.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months 5-6', 'description': 'Monthly acute headache medication days across Months 5 and 6 is calculated by taking the 2-month average of monthly acute headache medication days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.', 'unitOfMeasure': 'Monthly Acute Headache Medication Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'OG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'OG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '15.77', 'upperLimit': '21.51'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '16.58', 'upperLimit': '22.27'}, {'value': '19.0', 'groupId': 'OG002', 'lowerLimit': '16.15', 'upperLimit': '21.87'}]}]}], 'analyses': [{'pValue': '=0.837', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-3.18', 'ciUpperLimit': '3.93', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.81', 'estimateComment': 'LS Mean Difference = BOTOX 195 U - Placebo', 'groupDescription': 'BOTOX 195 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the visit at Month 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline MSQ v2.1 RFR Domain Score as a covariate, included as a continuous variable. Subject and residual errors are random effects.'}, {'pValue': '=0.662', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-2.74', 'ciUpperLimit': '4.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.79', 'estimateComment': 'LS Mean Difference = BOTOX 155 U - Placebo', 'groupDescription': 'BOTOX 155 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI obtained from mixed-effects model for repeated measures (MMRM) for primary analysis of the visit at Month 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline MSQ v2.1 RFR Domain Score as a covariate, included as a continuous variable. Subject and residual errors are random effects.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine over the past 4 weeks. It is divided into 3 domains, and the Role Function Restrictive (RFR) assesses how migraines limit one\'s daily social and work-related activities using a 6-point scale ranging from "none of the time" to "all of the time". Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. Positive changes from Baseline indicate improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score Across Months 5 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'OG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'OG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'groupId': 'OG000', 'lowerLimit': '-6.23', 'upperLimit': '-3.82'}, {'value': '-4.6', 'groupId': 'OG001', 'lowerLimit': '-5.82', 'upperLimit': '-3.39'}, {'value': '-4.9', 'groupId': 'OG002', 'lowerLimit': '-6.07', 'upperLimit': '-3.66'}]}]}], 'analyses': [{'pValue': '=0.834', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '1.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'LS Mean Difference = BOTOX 195 U - Placebo', 'groupDescription': 'BOTOX 195 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI are obtained from mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline AIM-D Physical Impairment domain score as a covariate, included as a continuous variable. Subject and residual errors are random effects.'}, {'pValue': '=0.578', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '1.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'LS Mean Difference = BOTOX 155 U - Placebo', 'groupDescription': 'BOTOX 155 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI are obtained from mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline AIM-D Physical Impairment domain score as a covariate, included as a continuous variable. Subject and residual errors are random effects.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months 5-6', 'description': 'AIM-D Physical Impairment Domain score is calculated based on the summation of AIM-D items 6-9. Participants answer each question based on the level of difficulty experienced in the 24 hours prior, with "during your headache" indicated for when they reported a headache, using a 6-point rating scale ranging from "not difficult at all" to "extremely difficult". The raw daily score is transformed to a 0-100 scale, and the monthly score is calculated using the average daily scores, where a higher score indicates worse physical impairment. AIM-D Physical Impairment domain score across Months 5 and 6 is calculated by taking the 2-month average of AIM-D Physical Impairment domain scores over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total 6-item Headache Impact Test (HIT-6) Score Across Months 5 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'OG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'OG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.2', 'groupId': 'OG000', 'lowerLimit': '-7.26', 'upperLimit': '-5.08'}, {'value': '-6.9', 'groupId': 'OG001', 'lowerLimit': '-7.94', 'upperLimit': '-5.77'}, {'value': '-6.5', 'groupId': 'OG002', 'lowerLimit': '-7.62', 'upperLimit': '-5.45'}]}]}], 'analyses': [{'pValue': '=0.589', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.69', 'ciUpperLimit': '0.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.68', 'estimateComment': 'LS Mean Difference = BOTOX 195 U - Placebo', 'groupDescription': 'BOTOX 195 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI are obtained from a mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline total HIT-6 score as a covariate, included as a continuous variable. Subject and residual errors are random effects.'}, {'pValue': '=0.310', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.00', 'ciUpperLimit': '0.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.67', 'estimateComment': 'LS Mean Difference = BOTOX 155 U - Placebo', 'groupDescription': 'BOTOX 155 U vs Placebo', 'statisticalMethod': 'Mixed Model for Repeated Measures (MMRM)', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'P-value/95% CI are obtained from a mixed-effects model for repeated measures (MMRM) analysis for primary analysis of the 2 visits across Months 5 and 6. Tx (BOTOX 195 U, BOTOX 155 U, placebo), month (Months 1-6), country, strata of previous exposure to migraine prophylactic treatment, and Tx group-by-month interaction as fixed effects, with the Baseline total HIT-6 score as a covariate, included as a continuous variable. Subject and residual errors are random effects.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Months 5-6', 'description': 'The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant\'s ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject\'s ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). The Total 6-item Headache Impact Test (HIT-6) score across Months 5 and 6 is calculated by taking the 2-month average of total 6-item Headache Impact Test (HIT-6) scores over Months 5 and 6. Negative changes from Baseline in the HIT-6 score indicate improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population (as Randomized); data used are "observed data" (without imputation for missing values)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screening/Baseline Phase', 'description': 'Participants with 6 to 14 migraine days and \\< 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study.'}, {'id': 'FG001', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants randomized to receive placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'FG002', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants randomized to receive intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'FG003', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants randomized to receive intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}, {'id': 'FG004', 'title': 'Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U', 'description': 'Participants randomized to receive placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.'}, {'id': 'FG005', 'title': 'Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U', 'description': 'Participants randomized to receive intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.'}, {'id': 'FG006', 'title': 'Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U', 'description': 'Participants randomized to receive intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase.'}], 'periods': [{'title': 'Screening/Baseline Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '775'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '775'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Double-Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '257'}, {'groupId': 'FG002', 'numSubjects': '257'}, {'groupId': 'FG003', 'numSubjects': '261'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '257'}, {'groupId': 'FG002', 'numSubjects': '256'}, {'groupId': 'FG003', 'numSubjects': '261'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '217'}, {'groupId': 'FG002', 'numSubjects': '230'}, {'groupId': 'FG003', 'numSubjects': '223'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '217'}, {'groupId': 'FG005', 'numSubjects': '230'}, {'groupId': 'FG006', 'numSubjects': '223'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '186'}, {'groupId': 'FG005', 'numSubjects': '199'}, {'groupId': 'FG006', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '13'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '7'}]}, {'type': 'Completed Double-Blind Phase and then withdrew from study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Completed Double-Blind Phase and then withdrew due to pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted at 118 sites in 9 countries and was initiated in November 2021. Adults with episodic migraine (EM) were eligible.', 'preAssignmentDetails': 'Participants were randomized in a 1:1:1 ratio to receive 2 treatment cycles of BOTOX 195 U, BOTOX 155 U, or placebo. BOTOX (155 U or 195 U) or matching placebo was administered by a trained injector at Day 1 and Week 12 of the Double-Blind Phase. Those who continued to the Open-label Phase received BOTOX 195 U at 12-week intervals for up to 2 treatment cycles.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '261', 'groupId': 'BG002'}, {'value': '775', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12.'}, {'id': 'BG001', 'title': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12.'}, {'id': 'BG002', 'title': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '10.37', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '10.76', 'groupId': 'BG002'}, {'value': '40.8', 'spread': '10.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '231', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}, {'value': '682', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '233', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}, {'value': '684', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}, {'value': '706', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat Population (as randomized)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-03', 'size': 2348592, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-10-31T10:43', 'hasProtocol': True}, {'date': '2024-06-03', 'size': 1037761, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-10-31T10:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 775}}, 'statusModule': {'whyStopped': 'The study was terminated early due to lack of efficacy from the primary analysis results.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'dispFirstSubmitDate': '2025-08-21', 'completionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2021-08-25', 'resultsFirstSubmitDate': '2025-10-31', 'studyFirstSubmitQcDate': '2021-08-25', 'dispFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-24', 'studyFirstPostDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6', 'timeFrame': 'Baseline, Months 5-6', 'description': 'The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs)', 'timeFrame': 'Double-Blind Phase (Week 0-24); Open-Label Phase (Week 24-48)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Frequency of Monthly Headache Days Across Months 5 and 6', 'timeFrame': 'Baseline, Months 5-6', 'description': 'The frequency of monthly headache days across Months 5 and 6 is calculated by taking the 2-month average of monthly headache days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.'}, {'measure': 'Percentage of Participants With ≥ 50% Reduction From Baseline in the Frequency of Monthly Migraine Days Across Months 5 and 6', 'timeFrame': 'Baseline, Months 5-6', 'description': 'The frequency of monthly migraine days across Months 5 and 6 is calculated by taking the 2-month average of monthly migraine days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. The responder status of 50% reduction from Baseline is defined as a participant with at least a 50% reduction from Baseline in the 2-month average of monthly migraine days over Months 5 and 6.'}, {'measure': 'Change From Baseline in the Frequency of Monthly Acute Headache Medication Days Across Months 5 and 6', 'timeFrame': 'Baseline, Months 5-6', 'description': 'Monthly acute headache medication days across Months 5 and 6 is calculated by taking the 2-month average of monthly acute headache medication days over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.'}, {'measure': 'Change From Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Role Function - Restrictive (RFR) Domain Score At Month 6', 'timeFrame': 'Baseline, Month 6', 'description': 'The MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine over the past 4 weeks. It is divided into 3 domains, and the Role Function Restrictive (RFR) assesses how migraines limit one\'s daily social and work-related activities using a 6-point scale ranging from "none of the time" to "all of the time". Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. Positive changes from Baseline indicate improvement.'}, {'measure': 'Change From Baseline in the Activity Impairment in Migraine - Diary (AIM-D) Physical Impairment Domain Score Across Months 5 and 6', 'timeFrame': 'Baseline, Months 5-6', 'description': 'AIM-D Physical Impairment Domain score is calculated based on the summation of AIM-D items 6-9. Participants answer each question based on the level of difficulty experienced in the 24 hours prior, with "during your headache" indicated for when they reported a headache, using a 6-point rating scale ranging from "not difficult at all" to "extremely difficult". The raw daily score is transformed to a 0-100 scale, and the monthly score is calculated using the average daily scores, where a higher score indicates worse physical impairment. AIM-D Physical Impairment domain score across Months 5 and 6 is calculated by taking the 2-month average of AIM-D Physical Impairment domain scores over Months 5 and 6. Month 5 and Month 6 are the 28-day daily diary periods ending with Days 56 and Days 84 after the second study treatment intervention day with BOTOX or placebo injections, respectively. Negative changes from Baseline indicate improvement.'}, {'measure': 'Change From Baseline in the Total 6-item Headache Impact Test (HIT-6) Score Across Months 5 and 6', 'timeFrame': 'Baseline, Months 5-6', 'description': 'The HIT-6 is a 6-item assessment used to measure the impact headaches have on a participant\'s ability to function on the job, at school, at home and in social situations. It assesses the effect that headaches have on normal daily life and the subject\'s ability to function. Responses are based on frequency using a 5-point scale ranging from "never" to "always." The HIT-6 total score, which ranges from 36 to 78, is the sum of the responses, each of which is assigned a score ranging from 6 points (never) to 13 points (always). The Total 6-item Headache Impact Test (HIT-6) score across Months 5 and 6 is calculated by taking the 2-month average of total 6-item Headache Impact Test (HIT-6) scores over Months 5 and 6. Negative changes from Baseline in the HIT-6 score indicate improvement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Migraine', 'Episodic Migraine', 'BOTOX', 'Botulinum Toxin Type A'], 'conditions': ['Episodic Migraine']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M21-307', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound (International Classification of Headache Disorders, 2018). Migraine can be further categorized according to the frequency of attacks as episodic migraine (EM) or chronic migraine (CM). This study will assess the effects of BOTOX in preventing migraine in adult participants with EM.\n\nBOTOX is being developed for the prevention of migraine in adults with episodic migraine (EM). Participants will be enrolled in 3 different treatment groups. There is 1 in 3 chance that participants will be assigned to receive placebo. Approximately 777 adult participants with EM will be enrolled in approximately 125 sites across the world.\n\nParticipants will receive intramuscular injections (injected into the muscle) of BOTOX or Placebo on Day 1 and Week 12. Eligible participants will receive BOTOX on Week 24 and Week 36.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of migraine headache disorder meeting International Classification of Headache Disorders (ICHD)-3 diagnostic criteria for migraine with aura or migraine without aura for \\>= 12 months.\n* Onset of migraine before 50 years of age.\n* History of 6 to 14 migraine days/month in each of the 3 months prior to Visit 1.\n* Six to 14 migraine/probable migraine days during the 4-week screening/baseline phase.\n* Less than 15 headache days/month in each of the 3 months prior to Visit 1 and during the 4-week screening/baseline phase.\n\nExclusion Criteria:\n\n* Current diagnosis of chronic migraine according to ICHD-3.\n* History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, chronic tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache.\n* History of headache attributed to another disorder (e.g., cervical dystonia, craniotomy, head/neck trauma) with exception that medication overuse headache per ICHD-3 criteria is allowed.\n* History of inadequate response to \\> 4 prophylactic treatment for migraine, 2 of which have different mechanisms of action.\n* Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or within 90 days after the last dose of study drug.'}, 'identificationModule': {'nctId': 'NCT05028569', 'briefTitle': 'Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX (Botulinum Toxin Type A) for the Prevention of Migraine in Subjects With Episodic Migraine', 'orgStudyIdInfo': {'id': 'M21-307'}, 'secondaryIdInfos': [{'id': '2021-001979-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Double-Blind Phase: Placebo', 'description': 'Participants received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Phase: BOTOX 155 U', 'description': 'Participants received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12.', 'interventionNames': ['Drug: BOTOX']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Phase: BOTOX 195 U', 'description': 'Participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12.', 'interventionNames': ['Drug: BOTOX']}, {'type': 'EXPERIMENTAL', 'label': 'Open-Label Phase: BOTOX 195 U', 'description': 'Eligible participants received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36.', 'interventionNames': ['Drug: BOTOX']}], 'interventions': [{'name': 'BOTOX', 'type': 'DRUG', 'otherNames': ['Botulinum Toxin Type A'], 'description': 'Intramuscular Injection', 'armGroupLabels': ['Double-Blind Phase: BOTOX 155 U', 'Double-Blind Phase: BOTOX 195 U', 'Open-Label Phase: BOTOX 195 U']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intramuscular Injection', 'armGroupLabels': ['Double-Blind Phase: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244-5700', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'facility': 'Neurology and Neurodiagnostics of Alabama /ID# 231918', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '35805-4046', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rehabilitation & Neurological Services /ID# 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