Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-01-28 @ 12:44 PM
Study NCT ID:
NCT02629861
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2015-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Germany', 'Hungary', 'Italy', 'Ukraine']}, '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': 'C000604315', 'term': 'fremanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'USMedInfo@Tevapharm.com', 'phone': '1-888-483-8279', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Week 12', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.', 'otherNumAtRisk': 294, 'deathsNumAtRisk': 294, 'otherNumAffected': 113, 'seriousNumAtRisk': 294, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.', 'otherNumAtRisk': 289, 'deathsNumAtRisk': 289, 'otherNumAffected': 132, 'seriousNumAtRisk': 289, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 active injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.', 'otherNumAtRisk': 291, 'deathsNumAtRisk': 291, 'otherNumAffected': 133, 'seriousNumAtRisk': 291, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 88, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 102, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 110, 'numAffected': 55}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 93, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 134, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 126, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 191, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 245, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 234, 'numAffected': 86}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Lentigo maligna', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Status migrainosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 289, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 291, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.7', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-0.5'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-6.4', 'upperLimit': '-1.9'}, {'value': '-4.2', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '-2.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the primary analysis was conducted using the Wilcoxon rank-sum test as outlined in the SAP.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds) Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The change is calculated as postbaseline value - baseline value.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'PRIMARY', 'title': 'Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Discontinued from study due to AE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Week 12', 'description': 'An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '44.1', 'groupId': 'OG001'}, {'value': '47.0', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}, {'value': '48.4', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000'}, {'value': '49.0', 'groupId': 'OG001'}, {'value': '51.2', 'groupId': 'OG002'}]}]}, {'title': 'Overall - Months 1-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}, {'value': '47.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Month 1 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0032', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Month 2 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0048', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Month 3 P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Overall P-value based on Cochran-Mantel-Haenszel test stratified by baseline preventive medication use.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)', 'description': 'Responder rates were defined as the percentage of total subjects who reached at least a 50% reduction in the monthly average of headache days (as subjectively reported by participants in the study diary) of at least moderate severity relative to the baseline period. For the overall analysis (Month 1-3), patients who discontinued early were considered nonresponders. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The percentage reduction in monthly average is calculated as: ((baseline value - postbaseline value) / baseline value) \\* 100', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '0.0'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '-0.8'}, {'value': '-3.2', 'groupId': 'OG002', 'lowerLimit': '-5.2', 'upperLimit': '-1.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)', 'description': 'Patients recorded any migraine medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken on each day in their electronic headache diary device. Acute migraine-specific medication included triptans or ergots. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The change is calculated as postbaseline value - baseline value.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Migraine Days During the 4 Week Period After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '286', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '0.5'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '-1.3'}, {'value': '-4.0', 'groupId': 'OG002', 'lowerLimit': '-6.1', 'upperLimit': '-1.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds) Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The change is calculated as postbaseline value - baseline value.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; includes participants with observations'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Monthly Average Number of Migraine Days During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '-0.6'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-6.3', 'upperLimit': '-2.0'}, {'value': '-4.2', 'groupId': 'OG002', 'lowerLimit': '-6.2', 'upperLimit': '-2.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)', 'description': 'A subset of patients (specified in the protocol not to exceed 30%) were allowed to use 1 concomitant migraine preventive medication. This outcome only includes those participants who did not take concomitant preventive migraine medication during this study. A migraine day has been previously defined. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The change is calculated as postbaseline value - baseline value.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set of participants who did not receive concomitant migraine prevention medication'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Migraine-Related Disability Score (MIDAS), As Measured by the Migraine Disability Assessment At 4 Weeks After the Last (3rd) Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '287', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.5', 'groupId': 'OG000', 'lowerLimit': '-29.5', 'upperLimit': '-2.0'}, {'value': '-18.0', 'groupId': 'OG001', 'lowerLimit': '-39.0', 'upperLimit': '-6.0'}, {'value': '-19.0', 'groupId': 'OG002', 'lowerLimit': '-36.0', 'upperLimit': '-7.0'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0021', 'groupIds': ['OG000', 'OG002'], 'pValueComment': '0.05 level of significance', 'groupDescription': 'Due to the deviation from the normal distribution assumption of the data, the Wilcoxon rank-sum test was conducted as the primary analysis for each active treatment group and placebo treatment group for this endpoint.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 0), Treatment Week 12 (4 weeks after the 3rd dose)', 'description': 'The MIDAS questionnaire is a 5-item instrument developed to assess headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the previous 3 months. The total score, ie, the sum of the # lost days answered for the first 5 questions, is used for grading of disability, with scores of 0-5 lost days = grade 1 (little or no disability), 6-10 lost days =grade 2 (mild disability), 11-20 lost days = grade 3 (moderate disability), and ≥21 lost days interpreted as grade 4 (severe disability). Negative change from baseline scores indicate a reduction (improvement) in headache-related disability.', 'unitOfMeasure': 'lost days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Electrocardiogram Finding Shifts From Baseline to Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '276', 'groupId': 'OG001'}, {'value': '281', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'categories': [{'title': 'Normal / Normal', 'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '181', 'groupId': 'OG002'}]}, {'title': 'Normal / NCS', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}, {'title': 'Normal / CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'NCS / Normal', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}, {'title': 'NCS / NCS', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}, {'title': 'NCS / CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'CS / Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'CS / NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'CS / CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0), Treatment Week 12 (or early withdrawal)', 'description': '12-lead ECGs were performed before other assessments (eg, blood draws and administration of questionnaires) and performed in triplicate. The worst post-baseline finding for the patient is summarized. Only patients with both baseline and post-baseline ECGs are included. The ECG was evaluated by the investigator at the time of recording (signed and dated), and the printout was kept in the source documentation file. When potentially clinically significant findings were detected by the investigator, a cardiologist at a central diagnostic center was consulted for a definitive interpretation. Any ECG finding that was judged by the investigator as a potentially clinically significant change (worsening) compared with a baseline value was considered an adverse event. - NCS = abnormal, not clinically significant - CS = abnormal, clinically significant Shift format is: baseline finding / worst post-baseline finding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population of participants with both baseline and post-treatment ECGs'}, {'type': 'SECONDARY', 'title': 'Participants With Vital Signs Potentially Clinically Significant Abnormal Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'title': 'Participants with at least 1 abnormality', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Pulse Rate Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Systolic Blood Pressure Low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Diastolic Blood Pressure Low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Respiratory Rate Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment Days 28, 56 and 84. Changes from previous reading may reflect the baseline reading performed on Day 0.', 'description': 'Vital signs were performed before other assessments (eg, blood draws and administration of questionnaires). Vital signs with at least one participant showing potentially clinically significant abnormal findings included: - Pulse Rate Low: \\<=50 and decrease of \\>=15 beats per minute - Systolic Blood Pressure Low: \\<=90 mmHg and decrease of \\>=20 mmHg - Diastolic Blood Pressure High: \\>=105 mmHg and increase of \\>=15 mmHg - Diastolic Blood Pressure Low: \\<=50 mmHg and decrease of \\>=15 mmHg - Respiratory Rate Low: \\<10 breaths / minute', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population of participants with both baseline and post-treatment values for each vital sign.'}, {'type': 'SECONDARY', 'title': 'Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'title': 'Blood Urea Nitrogen (BUN)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bilirubin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Alanine Aminotransferase (ALT)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Aspartate Aminotransferase (AST)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Gamma Glutamyl Transferase (GGT)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Hemoglobin', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Hematocrit', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Leukocytes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Eosinophils/Leukocytes', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment Days 28, 56 and 84 (or early withdrawal)', 'description': 'Serum chemistry and hematology laboratory tests with potentially clinically significant abnormal findings included: - Blood Urea Nitrogen (BUN) High: \\>=10.71 mmol/L - Bilirubin High: \\>=34.2 umol/L - Alanine Aminotransferase (ALT): \\>=3\\*upper limit of normal (ULN) - Aspartate Aminotransferase (AST): \\>=3\\*upper limit of normal (ULN) - Gamma Glutamyl Transferase (GGT): \\>=3\\*upper limit of normal (ULN) - Hemoglobin: Male: \\<115 g/L or Female: \\<=95 g/L - Hematocrit: Male: \\<0.37 L/L or Female: \\<0.32 L/L - Leukocytes: \\>=20\\*10\\^9/L or \\<=3\\*10\\^9/L - Eosinophils/Leukocytes: \\>=10% - Platelets: \\>=700\\*10\\^9/L or \\<=75\\*10\\^9/L', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population of participants with at least one postbaseline result for the tests.'}, {'type': 'SECONDARY', 'title': 'Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '285', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'title': 'Participants with at least 1 abnormality', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Blood', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Urine glucose', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Ketones', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Urine protein', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Treatment Days 28, 56 and 84. Changes from previous reading reflect the baseline reading performed on Day 0.', 'description': 'Urinalysis with potentially clinically significant abnormal findings included: - Blood: \\>=2 unit increase from baseline - Urine Glucose (mg/dL): \\>=2 unit increase from baseline - Ketones (mg/dL): \\>=2 unit increase from baseline - Urine Protein (mg/dL): \\>=2 unit increase from baseline', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population of participants with at least one postbaseline result for the tests'}, {'type': 'SECONDARY', 'title': 'Prothrombin Time Shifts From Baseline to Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '284', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'categories': [{'title': 'Low / Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Low / Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'Low / High', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Normal / Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Normal / Normal', 'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}]}, {'title': 'Normal / High', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}, {'title': 'High / Low', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'High / Normal', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}, {'title': 'High / High', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 0), Treatment Endpoint (Week 12)', 'description': 'Shifts in prothrombin time from baseline to endpoint were summarized using patient counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range) Shift format is: baseline finding / endpoint finding', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population of participants with both baseline and posttreatment values'}, {'type': 'SECONDARY', 'title': 'Injection Site Reaction Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '290', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'title': 'Participants with >=1 injection site reaction', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Injection site induration', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Injection site haemorrhage', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Injection site pruritus', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Injection site urticaria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Injection site rash', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Injection site bruising', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Injection site dermatitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Injection site hypersensitivity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Injection site nodule', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Injection site oedema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Injection site warmth', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Week 12', 'description': 'Counts of participants who reported treatment-emergent injection site reactions as AEs are summarized. Preferred terms from MedDRA version 18.1 are offered without a threshold applied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Participants With Positive Electronic Columbia Suicide Severity Rating Scale Results After the First Dose of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '289', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'OG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'OG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'classes': [{'title': 'Suicidal Ideation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Suicidal Behaviour', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to Week 12', 'description': "The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) was used to assess the patient's suicidal ideation (severity and intensity) and behavior (Posner et al 2011). The eC-SSRS Baseline/Screening version was completed by the patient at visit 2, and the eC-SSRS Since Last Visit version was completed by the patient at all other time points. Any positive findings on the eC-SSRS Since Last Visit version required evaluation by a physician or doctoral-level psychologist. Findings after the first dose of study drug using the eC-SSRS Since Last Visit version are summarized.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'FG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'FG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '291'}, {'groupId': 'FG002', 'numSubjects': '290'}]}, {'type': 'Intent to Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '291'}, {'groupId': 'FG002', 'numSubjects': '290'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '291'}, {'groupId': 'FG002', 'numSubjects': '289'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}, {'groupId': 'FG001', 'numSubjects': '288'}, {'groupId': 'FG002', 'numSubjects': '287'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '264'}, {'groupId': 'FG002', 'numSubjects': '262'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 2995 patients with migraine provided written informed consent. Of the 2995 patients screened, 875 met entry criteria, including diagnostic criteria for episodic migraine (EM) and diary compliance during the run-in period, and were randomized into this study from 123 study centers by 123 investigators.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants randomized to receive placebo received three 1.5-mL placebo injections on Day 0, and a single 1.5-mL placebo injection on Days 28 and 56.'}, {'id': 'BG001', 'title': 'Fremanezumab 675 mg/Placebo/Placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.'}, {'id': 'BG002', 'title': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '41.3', 'spread': '12.04', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '11.41', 'groupId': 'BG001'}, {'value': '42.9', 'spread': '12.67', 'groupId': 'BG002'}, {'value': '41.8', 'spread': '12.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'categories': [{'title': '18-45 years', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '525', 'groupId': 'BG003'}]}, {'title': '46-65 years', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '332', 'groupId': 'BG003'}]}, {'title': '>65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}, {'value': '742', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '225', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '700', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', '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': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}, {'value': '770', 'groupId': 'BG003'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preventive Medication Use During Baseline Period', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '182', 'groupId': 'BG003'}]}, {'title': 'No', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '693', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eligible patients entered a 28-day run-in/baseline period during which headache information was captured daily throughout study participation using the electronic headache diary device. During randomization, patients were stratified based on sex, country, and baseline preventive migraine medication use (yes, no) to ensure balance for the covariates.', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '75.3', 'spread': '16.01', 'groupId': 'BG000'}, {'value': '74.2', 'spread': '15.42', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '15.77', 'groupId': 'BG002'}, {'value': '73.9', 'spread': '15.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time Since Initial Migraine Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}, {'value': '875', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19.9', 'spread': '11.87', 'groupId': 'BG000'}, {'value': '20.0', 'spread': '12.14', 'groupId': 'BG001'}, {'value': '20.7', 'spread': '12.85', 'groupId': 'BG002'}, {'value': '20.2', 'spread': '12.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Number of Headache Days of Any Duration And Any Severity During the 28 Day Baseline Period', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '872', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '2.45', 'groupId': 'BG000'}, {'value': '11.1', 'spread': '2.42', 'groupId': 'BG001'}, {'value': '11.0', 'spread': '2.49', 'groupId': 'BG002'}, {'value': '11.1', 'spread': '2.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Eligible patients entered a 28-day run-in/baseline period during which headache information was captured daily throughout study participation using the electronic headache diary device.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Three participants did not capture data in the e-diary.'}, {'title': 'Number of Migraine Days', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '872', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '2.65', 'groupId': 'BG000'}, {'value': '9.3', 'spread': '2.65', 'groupId': 'BG001'}, {'value': '8.9', 'spread': '2.63', 'groupId': 'BG002'}, {'value': '9.1', 'spread': '2.64', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Eligible patients entered a 28-day run-in/baseline period during which headache information was captured daily throughout study participation using the electronic headache diary device. Migraine headaches are as defined in The International Classification of Headache Disorders 3rd edition (ICHD-3).', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Three participants did not capture data in the e-diary.'}, {'title': 'Number of Headache Days of At Least Moderate Severity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '872', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '3.12', 'groupId': 'BG000'}, {'value': '7.2', 'spread': '3.14', 'groupId': 'BG001'}, {'value': '6.8', 'spread': '2.90', 'groupId': 'BG002'}, {'value': '7.0', 'spread': '3.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Eligible patients entered a 28-day run-in/baseline period during which headache information was captured daily throughout study participation using the electronic headache diary device. Headache severity was subjectively rated by the patient as mild, moderate or severe.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Three participants did not capture data in the e-diary.'}, {'title': 'Number of Days of Use of Any Acute Headache Medications', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '872', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '3.60', 'groupId': 'BG000'}, {'value': '7.8', 'spread': '3.74', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '3.37', 'groupId': 'BG002'}, {'value': '7.8', 'spread': '3.57', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Eligible patients entered a 28-day run-in/baseline period during which headache information (including information about use of headache medications) was captured daily throughout study participation using the electronic headache diary device.', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Three participants did not capture data in the e-diary.'}, {'title': 'Migraine Disability Assessment (MIDAS) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}, {'value': '864', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '37.3', 'spread': '27.59', 'groupId': 'BG000'}, {'value': '41.7', 'spread': '32.96', 'groupId': 'BG001'}, {'value': '38.0', 'spread': '33.19', 'groupId': 'BG002'}, {'value': '39.0', 'spread': '31.36', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The MIDAS questionnaire is a 5-item instrument developed to assess headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the previous 3 months. The total score, ie, the sum of the # lost days answered for the first 5 questions, is used for grading of disability, with scores of 0-5 = grade 1 (little or no disability), 6-10 =grade 2 (mild disability), 11-20 = grade 3 (moderate disability), and ≥21 interpreted as grade 4 (severe disability).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Eleven participants did not capture data in the e-diary.'}], 'populationDescription': 'Intent to treat (ITT) population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-30', 'size': 6144533, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-10T20:04', 'hasProtocol': True}, {'date': '2017-05-26', 'size': 2588756, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-10T20:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 875}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2018-04-06', 'completionDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-06', 'studyFirstSubmitDate': '2015-12-10', 'dispFirstSubmitQcDate': '2018-04-06', 'resultsFirstSubmitDate': '2018-10-10', 'studyFirstSubmitQcDate': '2015-12-10', 'dispFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-10', 'studyFirstPostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds) Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The change is calculated as postbaseline value - baseline value.'}, {'measure': 'Participants With Adverse Events', 'timeFrame': 'Day 1 to Week 12', 'description': 'An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents usual activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With At Least 50% Reduction In Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Study Drug', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment Month 1, Month 2, Month 3, Month 1-3 (Days 1 - Week 12)', 'description': 'Responder rates were defined as the percentage of total subjects who reached at least a 50% reduction in the monthly average of headache days (as subjectively reported by participants in the study diary) of at least moderate severity relative to the baseline period. For the overall analysis (Month 1-3), patients who discontinued early were considered nonresponders. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The percentage reduction in monthly average is calculated as: ((baseline value - postbaseline value) / baseline value) \\* 100'}, {'measure': 'Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medicine During the 12 Week Period After the First Dose of Study Drug', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)', 'description': 'Patients recorded any migraine medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken on each day in their electronic headache diary device. Acute migraine-specific medication included triptans or ergots. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The change is calculated as postbaseline value - baseline value.'}, {'measure': 'Change From Baseline in the Number of Migraine Days During the 4 Week Period After the First Dose of Study Drug', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 4)', 'description': 'A migraine day was defined as when at least 1 of the following situations occurred: - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for migraine with or without aura - a calendar day (0:00 to 23:59) demonstrating at least 4 consecutive hours of a headache endorsing criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing - a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific medications (triptans and ergot compounds) Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The change is calculated as postbaseline value - baseline value.'}, {'measure': 'Change From Baseline in the Monthly Average Number of Migraine Days During the 12 Week Period After the First Dose of Study Medication in Patients Not Receiving Concomitant Preventive Migraine Medications', 'timeFrame': 'Baseline (Days -28 to Day -1), Treatment (Days 1 - Week 12)', 'description': 'A subset of patients (specified in the protocol not to exceed 30%) were allowed to use 1 concomitant migraine preventive medication. This outcome only includes those participants who did not take concomitant preventive migraine medication during this study. A migraine day has been previously defined. Monthly averages are derived and normalized to 28 days equivalent by the following formula: (# days of efficacy variable over relevant period / # days with assessments recorded in the e-diary over the relevant period) \\* 28. The change is calculated as postbaseline value - baseline value.'}, {'measure': 'Change From Baseline in Migraine-Related Disability Score (MIDAS), As Measured by the Migraine Disability Assessment At 4 Weeks After the Last (3rd) Dose of Study Drug', 'timeFrame': 'Baseline (Day 0), Treatment Week 12 (4 weeks after the 3rd dose)', 'description': 'The MIDAS questionnaire is a 5-item instrument developed to assess headache-related disability based on lost days of activity in 3 domains (work, household work, and nonwork) over the previous 3 months. The total score, ie, the sum of the # lost days answered for the first 5 questions, is used for grading of disability, with scores of 0-5 lost days = grade 1 (little or no disability), 6-10 lost days =grade 2 (mild disability), 11-20 lost days = grade 3 (moderate disability), and ≥21 lost days interpreted as grade 4 (severe disability). Negative change from baseline scores indicate a reduction (improvement) in headache-related disability.'}, {'measure': 'Electrocardiogram Finding Shifts From Baseline to Overall', 'timeFrame': 'Baseline (Day 0), Treatment Week 12 (or early withdrawal)', 'description': '12-lead ECGs were performed before other assessments (eg, blood draws and administration of questionnaires) and performed in triplicate. The worst post-baseline finding for the patient is summarized. Only patients with both baseline and post-baseline ECGs are included. The ECG was evaluated by the investigator at the time of recording (signed and dated), and the printout was kept in the source documentation file. When potentially clinically significant findings were detected by the investigator, a cardiologist at a central diagnostic center was consulted for a definitive interpretation. Any ECG finding that was judged by the investigator as a potentially clinically significant change (worsening) compared with a baseline value was considered an adverse event. - NCS = abnormal, not clinically significant - CS = abnormal, clinically significant Shift format is: baseline finding / worst post-baseline finding'}, {'measure': 'Participants With Vital Signs Potentially Clinically Significant Abnormal Values', 'timeFrame': 'Treatment Days 28, 56 and 84. Changes from previous reading may reflect the baseline reading performed on Day 0.', 'description': 'Vital signs were performed before other assessments (eg, blood draws and administration of questionnaires). Vital signs with at least one participant showing potentially clinically significant abnormal findings included: - Pulse Rate Low: \\<=50 and decrease of \\>=15 beats per minute - Systolic Blood Pressure Low: \\<=90 mmHg and decrease of \\>=20 mmHg - Diastolic Blood Pressure High: \\>=105 mmHg and increase of \\>=15 mmHg - Diastolic Blood Pressure Low: \\<=50 mmHg and decrease of \\>=15 mmHg - Respiratory Rate Low: \\<10 breaths / minute'}, {'measure': 'Participants With Serum Chemistry and Hematology Potentially Clinically Significant Abnormal Results', 'timeFrame': 'Treatment Days 28, 56 and 84 (or early withdrawal)', 'description': 'Serum chemistry and hematology laboratory tests with potentially clinically significant abnormal findings included: - Blood Urea Nitrogen (BUN) High: \\>=10.71 mmol/L - Bilirubin High: \\>=34.2 umol/L - Alanine Aminotransferase (ALT): \\>=3\\*upper limit of normal (ULN) - Aspartate Aminotransferase (AST): \\>=3\\*upper limit of normal (ULN) - Gamma Glutamyl Transferase (GGT): \\>=3\\*upper limit of normal (ULN) - Hemoglobin: Male: \\<115 g/L or Female: \\<=95 g/L - Hematocrit: Male: \\<0.37 L/L or Female: \\<0.32 L/L - Leukocytes: \\>=20\\*10\\^9/L or \\<=3\\*10\\^9/L - Eosinophils/Leukocytes: \\>=10% - Platelets: \\>=700\\*10\\^9/L or \\<=75\\*10\\^9/L'}, {'measure': 'Participants With Urinalysis Laboratory Tests Potentially Clinically Significant Abnormal Results', 'timeFrame': 'Treatment Days 28, 56 and 84. Changes from previous reading reflect the baseline reading performed on Day 0.', 'description': 'Urinalysis with potentially clinically significant abnormal findings included: - Blood: \\>=2 unit increase from baseline - Urine Glucose (mg/dL): \\>=2 unit increase from baseline - Ketones (mg/dL): \\>=2 unit increase from baseline - Urine Protein (mg/dL): \\>=2 unit increase from baseline'}, {'measure': 'Prothrombin Time Shifts From Baseline to Endpoint', 'timeFrame': 'Baseline (Day 0), Treatment Endpoint (Week 12)', 'description': 'Shifts in prothrombin time from baseline to endpoint were summarized using patient counts grouped into three categories: - Low (below normal range) - Normal (within the normal range of 9.4 to 12.5 seconds) - High (above normal range) Shift format is: baseline finding / endpoint finding'}, {'measure': 'Injection Site Reaction Adverse Events', 'timeFrame': 'Day 1 to Week 12', 'description': 'Counts of participants who reported treatment-emergent injection site reactions as AEs are summarized. Preferred terms from MedDRA version 18.1 are offered without a threshold applied.'}, {'measure': 'Participants With Positive Electronic Columbia Suicide Severity Rating Scale Results After the First Dose of Study Drug', 'timeFrame': 'Day 1 to Week 12', 'description': "The electronic Columbia-Suicide Severity Rating Scale (eC-SSRS) was used to assess the patient's suicidal ideation (severity and intensity) and behavior (Posner et al 2011). The eC-SSRS Baseline/Screening version was completed by the patient at visit 2, and the eC-SSRS Since Last Visit version was completed by the patient at all other time points. Any positive findings on the eC-SSRS Since Last Visit version required evaluation by a physician or doctoral-level psychologist. Findings after the first dose of study drug using the eC-SSRS Since Last Visit version are summarized."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '36038833', 'type': 'DERIVED', 'citation': 'McAllister P, Cohen JM, Campos VR, Ning X, Janka L, Barash S. Impact of fremanezumab on disability outcomes in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. J Headache Pain. 2022 Aug 29;23(1):112. doi: 10.1186/s10194-022-01438-4.'}, {'pmid': '35331009', 'type': 'DERIVED', 'citation': 'Diener HC, McAllister P, Jurgens TP, Kessler Y, Ning X, Cohen JM, Campos VR, Barash S, Silberstein SD. Safety and tolerability of fremanezumab in patients with episodic and chronic migraine: a pooled analysis of phase 3 studies. Cephalalgia. 2022 Jul;42(8):769-780. doi: 10.1177/03331024221076485. Epub 2022 Mar 25.'}, {'pmid': '34819017', 'type': 'DERIVED', 'citation': 'Nahas SJ, Naegel S, Cohen JM, Ning X, Janka L, Campos VR, Krasenbaum LJ, Holle-Lee D, Kudrow D, Lampl C. Efficacy and safety of fremanezumab in clinical trial participants aged >/=60 years with episodic or chronic migraine: pooled results from 3 randomized, double-blind, placebo-controlled phase 3 studies. J Headache Pain. 2021 Nov 24;22(1):141. doi: 10.1186/s10194-021-01351-2.'}, {'pmid': '33413075', 'type': 'DERIVED', 'citation': 'Silberstein SD, Cohen JM, Yang R, Gandhi SK, Du E, Jann AE, Marmura MJ. Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. J Headache Pain. 2021 Jan 7;22(1):2. doi: 10.1186/s10194-020-01212-4.'}, {'pmid': '31752521', 'type': 'DERIVED', 'citation': 'Brandes JL, Kudrow D, Yeung PP, Sakai F, Aycardi E, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2020 Apr;40(5):470-477. doi: 10.1177/0333102419885905. Epub 2019 Nov 21.'}, {'pmid': '29800211', 'type': 'DERIVED', 'citation': 'Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T, Grozinski-Wolff M, Yang R, Ma Y, Aycardi E. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018 May 15;319(19):1999-2008. doi: 10.1001/jama.2018.4853.'}]}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate two doses of TEV-48125 in adult patients with episodic migraine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females aged 18 to 70 years, inclusive, with migraine onset at ≤50 years of age\n* Patient signs and dates the informed consent document\n* Patient has history of migraine according to International Classification of Headache Disorders, or clinical judgment suggests a migraine diagnosis\n* 85% e-diary compliance\n* Total body weight between 99 and 265 lbs, inclusive\n\n * Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Clinically significant hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease, at the discretion of the investigator\n* Evidence or medical history of clinically significant psychiatric issues, including any suicide attempt in the past, or suicidal ideation with a specific plan in the past 2 years\n* History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological \\[eg, cerebral ischemia\\], peripheral extremity ischemia, or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism\n* Known infection or history of human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection\n* Past or current history of cancer in the last 5 years, except for appropriately treated nonmelanoma skin carcinoma\n* Pregnant or nursing females\n* History of hypersensitivity reactions to injected proteins, including monoclonal antibodies\n* Participation in a clinical study of a new chemical entity or a prescription medicine within 2 months or 5 half-lives, whichever is longer\n\n * Additional criteria apply, please contact the investigator for more information'}, 'identificationModule': {'nctId': 'NCT02629861', 'briefTitle': 'Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) vs Placebo for the Preventive Treatment of Episodic Migraine', 'orgStudyIdInfo': {'id': 'TV48125-CNS-30050'}, 'secondaryIdInfos': [{'id': '2015-004598-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Fremanezumab 675 mg/placebo/placebo', 'description': 'Participants randomized to receive fremanezumab 675 mg/placebo/placebo received 675 mg of fremanezumab as 3 injections (225 mg/1.5 mL) on Day 0, and placebo as a single 1.5-mL injection on Days 28 and 56.', 'interventionNames': ['Drug: Fremanezumab', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Fremanezumab 225/225/225 mg', 'description': 'Participants randomized to receive fremanezumab 225/225/225 mg received 1 active injection (225 mg/1.5 mL) on Days 0, 28 and 56.', 'interventionNames': ['Drug: Fremanezumab']}], 'interventions': [{'name': 'Fremanezumab', 'type': 'DRUG', 'otherNames': ['TEV-48125, anti-calcitonin gene-related peptide (anti-CGRP)'], 'description': 'Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration.\n\nThe 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.', 'armGroupLabels': ['Fremanezumab 225/225/225 mg', 'Fremanezumab 675 mg/placebo/placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.', 'armGroupLabels': ['Fremanezumab 675 mg/placebo/placebo', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 13628', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35216', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 13577', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 13577', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 13628', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 13606', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 13579', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 13579', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 13606', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Teva Investigational Site 13602', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Teva Investigational Site 13602', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13568', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13568', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13546', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13546', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13540', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13540', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13632', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13632', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13571', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13571', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13573', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13573', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13538', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13538', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '95405', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13594', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13594', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13595', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 13595', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80014', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13629', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13629', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13557', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13557', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80918', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13593', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13593', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80210', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13633', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80239', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13612', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13612', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13633', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13631', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 13631', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '06118', 'city': 'East Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Teva Investigational Site 13563', 'geoPoint': {'lat': 41.78232, 'lon': -72.61203}}, {'city': 'East Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Teva Investigational Site 13563', 'geoPoint': {'lat': 41.78232, 'lon': -72.61203}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Teva Investigational Site 13550', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Teva Investigational Site 13550', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13635', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13635', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13597', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13597', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33012', 'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13607', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'city': 'Hialeah', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13607', 'geoPoint': {'lat': 25.8576, 'lon': -80.27811}}, {'zip': '32205', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13559', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13559', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13584', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13584', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13587', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13551', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13555', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13587', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13599', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13553', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13553', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13616', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13616', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13567', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 13567', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30312', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 13620', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 13537', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 13537', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 13620', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '83642', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Teva Investigational Site 13604', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'Teva Investigational Site 13604', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 13585', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60654', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 13621', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 13585', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 13621', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 13627', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 13627', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46254', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Teva Investigational Site 13596', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Teva Investigational Site 13596', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Teva Investigational Site 13617', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67211', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Teva Investigational Site 13598', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Teva Investigational Site 13598', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Teva Investigational Site 13617', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Teva Investigational Site 13566', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Teva Investigational Site 13566', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Teva Investigational Site 13603', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Teva Investigational Site 13603', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 13582', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21208', 'city': 'Pikesville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 13582', 'geoPoint': {'lat': 39.37427, 'lon': -76.72247}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13590', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13590', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02301', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13589', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13589', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '02481', 'city': 'Wellesley Hills', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13543', 'geoPoint': {'lat': 42.30843, 'lon': -71.27867}}, {'city': 'Wellesley Hills', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 13543', 'geoPoint': {'lat': 42.30843, 'lon': -71.27867}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Teva Investigational Site 13539', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Teva Investigational Site 13539', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55422', 'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Teva Investigational Site 13542', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'city': 'Golden Valley', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Teva Investigational Site 13542', 'geoPoint': {'lat': 45.00969, 'lon': -93.34912}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 13534', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 13534', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 13536', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 13619', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 13619', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68025', 'city': 'Fremont', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Teva Investigational Site 13618', 'geoPoint': {'lat': 41.43333, 'lon': -96.49808}}, {'city': 'Fremont', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Teva Investigational Site 13618', 'geoPoint': {'lat': 41.43333, 'lon': -96.49808}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Teva Investigational Site 13605', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Teva Investigational Site 13605', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Teva Investigational Site 13578', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Teva Investigational Site 13578', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'city': 'Martinsville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 13575', 'geoPoint': {'lat': 40.60121, 'lon': -74.55905}}, {'zip': '08869', 'city': 'Raritan', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 13575', 'geoPoint': {'lat': 40.56955, 'lon': -74.63294}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Teva Investigational Site 13588', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Teva Investigational Site 13588', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 13576', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 13576', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '11803', 'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 13565', 'geoPoint': {'lat': 40.77649, 'lon': -73.46735}}, {'city': 'Plainview', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational 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