Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-27 @ 10:12 PM
Study NCT ID:
NCT01816295
Status:
COMPLETED
Last Update Posted:
2015-12-28
First Post:
2013-03-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007006', 'term': 'Hypogonadism'}], 'ancestors': [{'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D043343', 'term': 'Testosterone Propionate'}], 'ancestors': [{'id': 'D013739', 'term': 'Testosterone'}, {'id': 'D000737', 'term': 'Androstenols'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045165', 'term': 'Testosterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Analysis population includes all evaluable, randomized patients who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Solution - Double Blind', 'description': 'Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.', 'otherNumAtRisk': 356, 'otherNumAffected': 143, 'seriousNumAtRisk': 356, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Testosterone Solution - Double Blind', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period.', 'otherNumAtRisk': 354, 'otherNumAffected': 148, 'seriousNumAtRisk': 354, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Testosterone Solution - OLE', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks in optional OLE period.', 'otherNumAtRisk': 558, 'otherNumAffected': 252, 'seriousNumAtRisk': 558, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gingival cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intestinal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bacterial disease carrier', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Endocarditis enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 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complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Chest injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Haematuria traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Scapula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lentigo maligna', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lung carcinoma cell type unspecified stage iv', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 356, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 558, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Solution', 'description': 'Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}, {'id': 'OG001', 'title': 'Testosterone Solution', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who completed 12 weeks of treatment and had non-missing testosterone concentration at week 12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Solution', 'description': 'Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}, {'id': 'OG001', 'title': 'Testosterone Solution', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '1.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.5', 'paramValue': '5.1', 'ciLowerLimit': '1.05', 'ciUpperLimit': '9.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with "5" corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who reported low sex drive at baseline with non-missing SAID Scale data at baseline and at least one post baseline visit. Missing data endpoints were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Solution', 'description': 'Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}, {'id': 'OG001', 'title': 'Testosterone Solution', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '0.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.5', 'paramValue': '2.9', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '6.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with "10" corresponding to "Full of Energy" or "Not Tired at All" (The Tiredness scale was reverse-mapped, as it was collected with "10" corresponding to "Extreme Tiredness"). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants who reported low energy at baseline with non-missing HED questionnaire at baseline and at least one post baseline visit. Missing data endpoints were imputed using LOCF.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Total International Prostate Symptom Score (IPSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}, {'value': '324', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Solution', 'description': 'Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}, {'id': 'OG001', 'title': 'Testosterone Solution', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}], 'classes': [{'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline to Week 36 (n=247, 255)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.442', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'groupDescription': 'Change from Baseline to Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'groupDescription': 'Change from Baseline to Week 36', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12, Week 36', 'description': 'The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with non-missing baseline IPSS measurement and at least one non-missing post baseline IPSS measurement. Missing data endpoints were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Solution', 'description': 'Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}, {'id': 'OG001', 'title': 'Testosterone Solution', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}], 'classes': [{'title': 'Double-Blind Baseline (n=350, 347)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=289, 299)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Open Label Baseline (n=269, 278)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 (n=219, 223)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Double Blind Baseline, Week 12, Open Label Baseline, Week 36', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with non-missing PSA result at the specified time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Solution', 'description': 'Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}, {'id': 'FG001', 'title': 'Testosterone Solution', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}], 'periods': [{'title': 'Double Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '357'}, {'groupId': 'FG001', 'numSubjects': '358'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '354'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '302'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}]}]}, {'title': 'OLE Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants who completed the DBP and still met eligibility criteria had option to enroll in OLE.', 'groupId': 'FG000', 'numSubjects': '275'}, {'comment': 'Participants who completed the DBP and still met eligibility criteria had option to enroll in OLE.', 'groupId': 'FG001', 'numSubjects': '283'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '227'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '56'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '357', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '715', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Solution', 'description': 'Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}, {'id': 'BG001', 'title': 'Testosterone Solution', 'description': 'Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 - 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 - 120 mg/day) for 24 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '11.35', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '10.58', 'groupId': 'BG001'}, {'value': '55.3', 'spread': '10.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '357', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '715', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '559', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '282', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '563', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'East Asia', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': 'South America', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}, {'title': 'North America', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '231', 'groupId': 'BG001'}, {'value': '463', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'spread': '4.21', 'groupId': 'BG000'}, {'value': '30.3', 'spread': '4.06', 'groupId': 'BG001'}, {'value': '30.6', 'spread': '4.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI is an estimate of body fat based on body weight divided by height squared.', 'unitOfMeasure': 'kilogram per square meter (kg/m²)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Symptoms of Hypogonadism', 'classes': [{'title': 'Only Low Energy', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Only Decreased Sexual Drive', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Both Symptoms Present', 'categories': [{'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '540', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 715}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-24', 'studyFirstSubmitDate': '2013-03-19', 'resultsFirstSubmitDate': '2015-09-01', 'studyFirstSubmitQcDate': '2013-03-19', 'lastUpdatePostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-01', 'studyFirstPostDateStruct': {'date': '2013-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Total International Prostate Symptom Score (IPSS)', 'timeFrame': 'Baseline, Week 12, Week 36', 'description': 'The IPSS is a self-administered instrument used to assess for the severity of lower urinary tract symptoms. The IPSS consists of 7 questions that were scored on a scale from 0 (none/no symptoms) to 5 (frequent symptoms), for a total score range of 0 to 35. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Total Serum Testosterone Concentration Within Normal Range at Week 12', 'timeFrame': 'Week 12', 'description': 'Normal range for total serum testosterone was defined as 300 to 1050 nanograms per deciliter (ng/dL).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Sexual Arousal, Interest, and Drive (SAID) Scale Scores', 'timeFrame': 'Baseline, Week 12', 'description': 'The SAID Scale is a self-administered instrument used to assess sexual arousal, interest, and sex drive in men with symptomatic hypogonadism. The SAID consists of 5 questions that were scored on a scale from 1 to 5, with "5" corresponding to greater levels of sexual arousal, interest, or drive. The SAID Scale total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater sexual arousal, interest, and drive. Least squares (LS) mean change from baseline was calculated using an analysis of covariance (ANCOVA) with treatment group and the baseline value as covariates.'}, {'measure': 'Change From Baseline to Week 12 in Hypogonadism Energy Diary (HED) Scores', 'timeFrame': 'Baseline, Week 12', 'description': 'The HED is a self-administered instrument used to assess real-time energy levels in men with symptomatic hypogonadism. It consists of 2 questions that were scored on a scale from 0 to 10, with "10" corresponding to "Full of Energy" or "Not Tired at All" (The Tiredness scale was reverse-mapped, as it was collected with "10" corresponding to "Extreme Tiredness"). The questionnaire was completed 3 times daily (forming 6 unique items) for 7 consecutive days. Item scores were computed by averaging the values for each item across 7 days. If more than 2 days were missing for an item, the item score was missing. The total score was computed by summing the item scores and linearly transforming the sum to a 0 to 100 scale, with higher scores corresponding to greater energy. If any item score was missing, the total score was missing. LS mean change from baseline was calculated using ANCOVA with treatment group and the baseline value as covariates.'}, {'measure': 'Number of Participants With Prostate Specific Antigen (PSA) >4 Nanogram/Milliliter (ng/mL)', 'timeFrame': 'Double Blind Baseline, Week 12, Open Label Baseline, Week 36'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypogonadism']}, 'referencesModule': {'references': [{'pmid': '38224135', 'type': 'DERIVED', 'citation': 'Lee H, Hwang EC, Oh CK, Lee S, Yu HS, Lim JS, Kim HW, Walsh T, Kim MH, Jung JH, Dahm P. Testosterone replacement in men with sexual dysfunction. Cochrane Database Syst Rev. 2024 Jan 15;1(1):CD013071. doi: 10.1002/14651858.CD013071.pub2.'}, {'pmid': '26498057', 'type': 'DERIVED', 'citation': 'Brock G, Heiselman D, Maggi M, Kim SW, Rodriguez Vallejo JM, Behre HM, McGettigan J, Dowsett SA, Hayes RP, Knorr J, Ni X, Kinchen K. Effect of Testosterone Solution 2% on Testosterone Concentration, Sex Drive and Energy in Hypogonadal Men: Results of a Placebo Controlled Study. J Urol. 2016 Mar;195(3):699-705. doi: 10.1016/j.juro.2015.10.083. Epub 2015 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate if testosterone solution can raise testosterone hormone levels into the normal range, and also improve levels of sexual arousal, interest and drive and/or energy level, in men with low testosterone and decreased sexual arousal, interest and drive and/or decreased energy. The study will last about 16 weeks, followed by an optional 24 week open label treatment phase to investigate the long term safety of testosterone solution.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total testosterone level \\<300 nanogram per deciliter (ng/dL) \\[10.4 nanomole per Liter (nmol/L)\\] at each of 2 screening visits\n* At least 1 symptom of testosterone deficiency, which must include decreased energy or decreased sexual drive\n* Prostate Specific Antigen (PSA) \\<4 nanogram per milliliter (ng/ml) at screening\n\nExclusion Criteria:\n\n* Sexual partner who is or becomes pregnant at any time during the study\n* Use of long-acting intramuscular (IM) testosterone undecanoate or testosterone pellets in the 6-month period prior to screening\n* Body Mass Index (BMI) \\>37 kilogram per square meter (kg/m\\^2) at screening\n* Severe lower urinary tract symptoms and/or significant prostate enlargement\n* Prolactin lab test result of \\>30 ng/mL at screening\n* Hemoglobin A1c (HbA1c) \\>11% at screening\n* Hematocrit ≥50% (\\>54% at elevated altitude) at screening\n* Current use of any medications, herbal, and/or nutritional supplements that can interfere with testosterone\n* Dermatologic condition in underarm area that might interfere with testosterone absorption (for example, eczema) or be exacerbated by topical testosterone replacement therapy\n* Currently receiving treatment with cancer chemotherapy or antiandrogens\n* Chronic use of systemic glucocorticoids (use for \\>14 days within the 3 months prior to screening); use of non-testosterone anabolic steroids within 12 months prior to screening\n* Competitive athletes involved in a sport in which they may be screened for anabolic steroids\n* History of use of estrogenizing agents within 12 months prior to screening\n* History of luteinizing hormone-releasing hormone antagonist or agonist treatment in the last 6 months prior to screening\n* History of clomiphene or other anti-estrogen treatment in the 3 months prior to screening\n* Use of finasteride within 3 months prior to screening, or use of dutasteride within 6 months prior to screening\n* Current use of warfarin or phenprocoumon\n* History of frequent opioid use: \\>1 time/week during any week within 30 days prior to screening\n* Current use of dopamine receptor agonists (cabergoline, pergolide, bromocriptine)\n* Have a history of significant central nervous system injuries or disease (including stroke, spinal cord injury, or multiple sclerosis) within 6 months prior to screening\n* Systolic blood pressure \\>170 or \\<90 millimeter of mercury (mm Hg) or diastolic blood pressure \\>100 or \\<50 mm Hg at screening or a history of malignant hypertension\n* History of unstable angina as defined by Braunwald Classification of Unstable Angina or angina occurring during sexual intercourse in the last 6 months\n* History of any of the following coronary conditions within 90 days of screening: myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (angioplasty or stent placement)\n* Have any supraventricular arrhythmia with an uncontrolled ventricular response \\[mean heart rate \\>100 beats per minute (bpm)\\] at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate \\>100 bpm for ≥30 seconds), or use of an automatic internal cardioverter-defibrillator\n* Have a history of sudden cardiac arrest\n* Exhibit any evidence of congestive heart failure \\[New York Heart Association (NYHA) Class 2 or above\\], within 6 months prior to screening\n* Have had a new, significant cardiac conduction defect within 90 days prior to screening\n* Clinical suspicion (or history) of prostate cancer during digital rectal examination at screening\n* Known or suspected breast cancer (or history of breast cancer) or other active cancer (with the exception of nonmelanotic skin cancer)\n* Exhibit evidence of severe renal impairment \\[creatinine clearance \\<30 milliliter per minute (mL/min) as determined by the Cockcroft-Gault formula\\] at screening\n* Exhibit a history of severe liver disease or clinical evidence of hepatic impairment at screening\n* Have a history of human immunodeficiency virus (HIV) infection\n* Severe sleep apnea\n* Untreated hypothyroidism, hypercortisolism or other significant endocrinopathy (other than hypogonadism) that contributes to symptoms of low energy or fatigue'}, 'identificationModule': {'nctId': 'NCT01816295', 'briefTitle': 'A Study in Men With Low Testosterone to Measure the Effects of Testosterone Solution on Testosterone Levels, Sex Drive and Energy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Parallel Study With an Open-Label Extension to Assess the Impact of Testosterone Solution on Total Testosterone, Sex Drive and Energy in Hypogonadal Men', 'orgStudyIdInfo': {'id': '14396'}, 'secondaryIdInfos': [{'id': 'I5E-MC-TSAT', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2012-004866-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Solution', 'description': 'Placebo Solution applied topically once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Testosterone Solution', 'description': 'Testosterone Solution 60 milligram (mg) applied topically once daily with possible titration down to 30 milligram per day (mg/day) or up to 120 mg/day for 12 weeks and optional extension for 24 weeks.', 'interventionNames': ['Drug: Testosterone Solution']}], 'interventions': [{'name': 'Testosterone Solution', 'type': 'DRUG', 'otherNames': ['Axiron', 'Testosterone Solution 2%', 'LY900011'], 'description': 'Administered topically to axillae.', 'armGroupLabels': ['Testosterone Solution']}, {'name': 'Placebo Solution', 'type': 'DRUG', 'description': 'Administered topically to axillae.', 'armGroupLabels': ['Placebo Solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Spring Valley', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.74477, 'lon': -116.99892}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Oviedo', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.67, 'lon': -81.20812}}, {'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'city': 'Meridian', 'state': 'Idaho', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.61211, 'lon': -116.39151}}, {'city': 'Crystal Lake', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.24113, 'lon': -88.3162}}, {'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Greenbelt', 'state': 'Maryland', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.00455, 'lon': -76.87553}}, {'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Bala-Cynwyd', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.00761, 'lon': -75.23407}}, {'city': 'Greer', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.93873, 'lon': -82.22706}}, {'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Clinton', 'state': 'Utah', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.13967, 'lon': -112.0505}}, {'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Caba', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'city': 'Burlington', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.38621, 'lon': -79.83713}}, {'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'city': 'Hamburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hettstedt', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.6503, 'lon': 11.51146}}, {'city': 'Holzminden', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.82798, 'lon': 9.4455}}, {'city': 'Marburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bergamo', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Bologna', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rozzano', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Goyang-si', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Kwangju', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'A Coruña', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.42378, 'lon': -3.56129}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Majadahonda', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Hathersage Road', 'state': 'Manchester', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'city': 'Barnsley', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.55, 'lon': -1.48333}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}