Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 8:29 PM
Study NCT ID:
NCT00700427
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2008-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25', 'removedCountries': ['Argentina', 'Canada', 'Denmark', 'Mexico', 'Puerto Rico', 'Russia', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Atomoxetine (Study Periods 2 and 3A)', 'description': '40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).', 'otherNumAtRisk': 2011, 'otherNumAffected': 1611, 'seriousNumAtRisk': 2011, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'Atomoxetine (Study Period 3B)', 'description': '40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).\n\nFollowed by 80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).', 'otherNumAtRisk': 266, 'otherNumAffected': 120, 'seriousNumAtRisk': 266, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'Placebo (Study Period 3B)', 'description': '40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A).\n\nFollowed by Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).', 'otherNumAtRisk': 258, 'otherNumAffected': 96, 'seriousNumAtRisk': 258, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Atomoxetine (Study Period 4; Open-Label Extension)', 'description': '40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2), and 80-100 mg/day for 12 weeks during double-blind maintenance phase of Study Period 3 (Study Period 3A) and for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B), followed by a 2 year open label extension (Study Period 4). The open-label extension was optional and only offered to participants living in countries where atomoxetine for the adult ADHD indication had not been approved who had completed the Study Period 3B and were receiving benefit from the drug.', 'otherNumAtRisk': 180, 'otherNumAffected': 119, 'seriousNumAtRisk': 180, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 90, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 73, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 46, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 32, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 41, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 73, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 99, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 60, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 368, 'numAffected': 342}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 72, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 707, 'numAffected': 552}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 96, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 60, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 292, 'numAffected': 262}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 87, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 57, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 55, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 153, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 39, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 62, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatitis alcoholic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Splenic injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Depressive symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bunion operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin neoplasm excision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2011, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 266, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 258, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 24) up to Week 49', 'description': "Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits.", 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary outcome measure analysis was conducted using all randomized participants in the Double-Blind Maintenance/Randomized Withdrawal Period (Study Period 3B).'}, {'type': 'SECONDARY', 'title': 'Number of Days Until Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'The mean and standard deviation could not be reliably estimated because of low numbers of participants who relapsed.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'The mean and standard deviation could not be reliably estimated because of low numbers of participants who relapsed.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 24) up to Week 49', 'description': "Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.\n\nCAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were conducted using all randomized participants in the Double-Blind Period (Study Period 3B).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': 'The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with a baseline and at least 1 post-baseline AAQoL score were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49", 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}], 'classes': [{'title': 'ADHD Imputed (Attributed) Index Score (N=164, 153)', 'categories': [{'measurements': [{'value': '-2.60', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity/Impulsivity Subscale Imputed Score', 'categories': [{'measurements': [{'value': '-1.90', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Inattention Subscale Imputed Score', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Total ADHD Symptom Imputed Score', 'categories': [{'measurements': [{'value': '-3.50', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '-0.40', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for ADHD Imputed (Attributed) Index Score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Hyperactivity/Impulsivity Subscale Imputed Score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Inattention Subscale Imputed Score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Total ADHD Symptom Imputed Score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': 'The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a non-missing baseline and at least 1 post-baseline CAARS-O:SV result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49", 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}], 'classes': [{'title': 'ADHD Symptom Imputed Index Score', 'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': 'Hyperactivity-Impulsivity Subscale Imputed Score', 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.32', 'groupId': 'OG001'}]}]}, {'title': 'Inattention Subscale Imputed Score', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '1.20', 'spread': '0.37', 'groupId': 'OG001'}]}]}, {'title': 'Total ADHD Symptom Imputed Score', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for ADHD Imputed (Attributed) Index Score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Hyperactivity/Impulsivity Subscale Imputed Score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Inattention Subscale Imputed Score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Total ADHD Symptom Imputed Score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': 'CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a non-missing baseline and at least 1 post-baseline CAARS-S:SV result within each treatment group, Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.70', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': "The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Self Report result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.4', 'spread': '2.16', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': "BRIEF-A:Informant is a 75-item third-party observer's view of the participants' executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a non-missing baseline and at least 1 post-baseline BRIEF-A:Informant result within each group, Last Observation Carried Forward (LOCF) were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atomoxetine', 'description': '80-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}], 'classes': [{'title': 'UK population-based Index Score (n=194, 180)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'US population-based Index Score (n=194, 180)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.01', 'groupId': 'OG001'}]}]}, {'title': 'Health State Score (N=197, 179)', 'categories': [{'measurements': [{'value': '4.60', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': 'The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with \\<0 interpreted as a health state "worse than dead." A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with a non-missing baseline and at least 1 post-baseline EQ-5D Index Score or VAS score within each group, Last Observation Carried Forward (LOCF) were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atomoxetine (Study Period 2)', 'description': '40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment phase (Study Period 2).'}, {'id': 'FG001', 'title': 'Atomoxetine (Study Period 3A)', 'description': '40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during double-blind randomized withdrawal phase (Study Period 3).'}, {'id': 'FG002', 'title': 'Atomoxetine (Study Period 3B)', 'description': '80-100 mg/day atomoxetine orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'FG003', 'title': 'Placebo (Study Period 3B)', 'description': 'Placebo orally, once daily or twice daily for 25 weeks during double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B).'}, {'id': 'FG004', 'title': 'Atomoxetine (Study Period 4)', 'description': 'Participants who received either atomoxetine or placebo and completed the last visit of Study Period 3 who were in countries where the adult ADHD indication for atomoxetine was not approved were allowed to participant in Study Period 4 (Open-label Extension). Participants received 40 mg/day atomoxetine orally for at least 7 days after which it was increased to 80-100 mg/day atomoxetine orally for up to 2.3 years.'}], 'periods': [{'title': 'Study Period 2 (Open-Label Acute Trx)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2017'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2011'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One participant was mistakenly recorded as completed. The reason for discontinuation is unknown.', 'groupId': 'FG000', 'numSubjects': '1006'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1011'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Interim Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Clinical Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Study Period 3A (Blinded Maintenance)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1005'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '524'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '481'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Interim Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Clinical Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '41'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Missing - Not Otherwise Defined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Study Period 3B (Randomized Withdrawal)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '266'}, {'groupId': 'FG003', 'numSubjects': '258'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '184'}, {'groupId': 'FG003', 'numSubjects': '165'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '82'}, {'groupId': 'FG003', 'numSubjects': '93'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Interim Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Clinical Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Study Period 4 (Open-Label Extension)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '180'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '84'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '16'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '38'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '11'}]}, {'type': 'Clinical Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study consisted of 4 treatment periods: 12 weeks open-label, acute-treatment (trx) phase (Study Period 2), 12 weeks double-blind maintenance phase of Study Period 3 (Study Period 3A), 25 weeks double-blind randomized withdrawal phase of Study Period 3 (Study Period 3B) and an Open-Label Extension Period (Study Period 4) lasting up to 2.3 years.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2017', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Atomoxetine (40-100 mg)', 'description': '40-100 milligrams/day (mg/day) atomoxetine orally, once daily or twice daily for 12 weeks during open-label, acute-treatment period (Study Period 2).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.15', 'spread': '9.09', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '833', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1184', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1765', 'groupId': 'BG000'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'West Asian', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '434', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '153', 'groupId': 'BG000'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '602', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2017}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-12', 'studyFirstSubmitDate': '2008-06-16', 'resultsFirstSubmitDate': '2012-08-23', 'studyFirstSubmitQcDate': '2008-06-17', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-18', 'studyFirstPostDateStruct': {'date': '2008-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period', 'timeFrame': 'Baseline (Week 24) up to Week 49', 'description': "Conners' Adult ADHD Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV); 30-item scale (3 subscales): inattention, hyperactivity/impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (not at all/never) to 3 (very much/very frequently). Total ADHD symptoms score (SS)=inattention+hyperactivity/impulsivity (range:0-54). Higher score=more impairment. Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Maintenance of response during the randomized withdrawal phase was a reduction of ≥30% in the baseline CAARS-Inv:SV Total ADHD SS and a CGI-ADHD-S score ≤3. Participants had to continuously meet the response criteria, except for 1 excursion after assessment at Week 24 through Week 37 and 1 other excursion after assessment at Week 37 through Week 49. Excursions were not permitted at 2 consecutive visits."}], 'secondaryOutcomes': [{'measure': 'Number of Days Until Relapse', 'timeFrame': 'Baseline (Week 24) up to Week 49', 'description': "Relapse was defined as 2 consecutive visits with a CGI-ADHD-S score ≥4 points and a return to ≥80% of participant's baseline (Visit 2) CAARS-Inv:SV Total ADHD Symptom Score (SS). If the participant showed evidence of a return of symptoms at a single visit that met severity criteria described above, and because of worsening symptoms, was unwilling to remain in the study or did not return for a second visit, the participant was also considered to have relapsed.\n\nCAARS-Inv:SV is a 30-item scale (3 subscales): Inattention, Hyperactivity/Impulsivity (9 items each), ADHD Index (12 items). Each item is scored 0 (0=not at all/never) to 3 (very much/very frequently). Total ADHD SS=inattention+hyperactivity/impulsivity (range: 0-54). Higher score=more impairment. CGI-ADHD-S measures participant's overall severity of ADHD symptoms and scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants)."}, {'measure': 'Change From Baseline in the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life (AAQoL) Scale From Week 24 to Week 49', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': 'The AAQoL is a self-reported, 29-item scale assessing functional impairments in adults with ADHD. Each item is rated on a 5-point Likert scale; range: 1 (Not at all/ Never) to 5 (Extremely/Very Often). 5-domains of scale include: work functioning, family relationships, social functioning, activities of daily living (driving, managing finances), and psychological adaptation (life satisfaction, self-esteem). These scores are transformed to a 0-100 point scale (1=0; 2=25; 3=50; 4=75; 5=100), and then the item scores are summed and divided by item count to generate overall scores. The overall scores have the same total range of scores of 0-100, with higher scores indicating better quality of life. Least Squares (LS) Mean values were adjusted for baseline AAQoL score and Investigator/site.'}, {'measure': "Change From Baseline in Conner's Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (Observer Rated [CAARS-O:SV]) Total ADHD Symptom Score From Week 24 to Week 49", 'timeFrame': 'Baseline (Week 24), Week 49', 'description': 'The CAARS-O:SV is a 30-item observer (typically a significant other or close friend) completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales, ranging from 0-54, with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.'}, {'measure': "Change From Baseline in Conner's Adult ADHD Rating Scale-Self Rated (CARRS-S:SV) Total ADHD Symptom Score From Week 24 to Week 49", 'timeFrame': 'Baseline (Week 24), Week 49', 'description': 'CAARS-S:SV is a 30-item participant completed scale containing 3 subscales: inattention (9 items), hyperactivity/impulsivity (9 items), ADHD Index (12 items). 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Inattention and hyperactivity subscales range from 0-27; ADHD index subscale range is 0-36 with higher scores indicating more impaired participants. Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales; range: 0-54 with higher scores indicating more impaired participants. Least Squares (LS) Mean values adjusted for treatment, pooled Investigator, and baseline.'}, {'measure': 'Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version: Self Report (BRIEF-A:Self Report) Global Executive Composite (GEC) Index Score From Week 24 to Week 49', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': "The BRIEF-A:Self Report is a 75-item self-reported measure captures adults' views of their own executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline."}, {'measure': 'Change From Baseline in the Behavior Rating Inventory of Executive Function-Adult Version:Informant Report (BRIEF-A:Informant) Global Executive Composite (GEC) Index Score From Week 24 to Week 49', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': "BRIEF-A:Informant is a 75-item third-party observer's view of the participants' executive functions/self-regulation in their everyday environment. Items include: Inhibit, Shift, Emotional Control, Self Monitor, Initiate, Working Memory, Plan/Organize, Task Monitor, and Organization of Materials. Behavior is rated on a 3-point scale: 1 (behavior is never observed) to 3 (behavior is often observed). GEC Index Score is a subscore of the 75-item BRIEF-A score, reflects overall functioning and was calculated based on 70 items. Total scores range: 70-210. Lower scores = less perceived impairment. Least Squares (LS) Mean values were adjusted for treatment, pooled Investigator, and baseline."}, {'measure': 'Change From Baseline in European Quality of Life (EuroQoL) Questionnaire-5 Dimensions (EQ-5D) Index Score From Week 24 to Week 49', 'timeFrame': 'Baseline (Week 24), Week 49', 'description': 'The EQ-5D is a Self-reported, 5-item scale to assess health utility (mobility, self-care, usual activities, pain and discomfort, and depression/anxiety). Scoring is on a 3-point scale (1=no health problems, 2=some or moderate problems, 3=major health problems). A preference value Index score is calculated using societal preference developed from a general population-based valuation studies. Index score ranges: United Kingdom (UK): -0.59 to 1.0, United States (US): -0.11 to 1.0, where 1 represents best possible health and 0 represents dead, with \\<0 interpreted as a health state "worse than dead." A Quality of Life Health State Score visual analog scale (VAS) was assessed, scores range from 0 to 100. Higher scores indicate better health state. Least Square (LS) Mean values were adjusted for treatment, pooled Investigator, baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADHD', 'Adult', 'long term', 'maintenance of response', 'Attention Deficit Hyperactivity Disorder'], 'conditions': ['Attention Deficit Hyperactivity Disorder']}, 'referencesModule': {'references': [{'pmid': '28058589', 'type': 'DERIVED', 'citation': 'Tanaka Y, Escobar R, Upadhyaya HP. Assessment of effects of atomoxetine in adult patients with ADHD: consistency among three geographic regions in a response maintenance study. Atten Defic Hyperact Disord. 2017 Jun;9(2):113-120. doi: 10.1007/s12402-016-0212-7. Epub 2017 Jan 6.'}, {'pmid': '26329980', 'type': 'DERIVED', 'citation': 'Upadhyaya H, Tanaka Y, Lipsius S, Kryzhanovskaya LA, Lane JR, Escobar R, Trzepacz PT, Allen AJ. Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD. Postgrad Med. 2015;127(7):677-85. doi: 10.1080/00325481.2015.1083394. Epub 2015 Sep 2.'}, {'pmid': '23648011', 'type': 'DERIVED', 'citation': 'Upadhyaya H, Adler LA, Casas M, Kutzelnigg A, Williams D, Tanaka Y, Arsenault J, Escobar R, Allen AJ. Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine. Child Adolesc Psychiatry Ment Health. 2013 May 6;7(1):14. doi: 10.1186/1753-2000-7-14.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults\n* Male or female\n* Must meet Attention-Deficit/Hyperactivity Disorder (ADHD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision™ (DSM-IV-TR™) criteria\n\nExclusion Criteria:\n\n* Comorbidity with major psychiatric disorder\n* Clinically significant depression or anxiety\n* Patients with significant medical conditions\n* Current alcohol/drugs abuse/dependence\n* Concomitant excluded medications'}, 'identificationModule': {'nctId': 'NCT00700427', 'briefTitle': 'A Long Term Study of a Medication for Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study', 'orgStudyIdInfo': {'id': '9655'}, 'secondaryIdInfos': [{'id': 'B4Z-MC-LYDO', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atomoxetine', 'description': 'Atomoxetine 40-100 milligrams per day (mg/day) orally, once daily or twice daily for 24 weeks, followed by atomoxetine 80-100 mg/day orally, once daily or twice daily for 25 weeks.', 'interventionNames': ['Drug: atomoxetine hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Atomoxetine 40-100 mg/day orally, once daily or twice daily for 24 weeks, followed by placebo orally, once daily for 25 weeks.', 'interventionNames': ['Drug: atomoxetine hydrochloride', 'Drug: Placebo']}], 'interventions': [{'name': 'atomoxetine hydrochloride', 'type': 'DRUG', 'otherNames': ['Strattera', 'LY139603', 'atomoxetine'], 'description': 'Oral 40-100 mg/day', 'armGroupLabels': ['Atomoxetine', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral delivery of matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A1090', 'city': 'Vienna', 'country': 'Austria', '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': 48.20849, 'lon': 16.37208}}, {'zip': '8310', 'city': 'Bruges', 'country': 'Belgium', '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': 51.20892, 'lon': 3.22424}}, {'zip': '3070', 'city': 'Kortenberg', 'country': 'Belgium', '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': 50.88982, 'lon': 4.54353}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', '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': 50.63373, 'lon': 5.56749}}, {'zip': '2800', 'city': 'Mechelen', 'country': 'Belgium', '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': 51.02574, 'lon': 4.47762}}, {'zip': '1180', 'city': 'Uccle', 'country': 'Belgium', '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': 50.80225, 'lon': 4.33943}}, {'zip': '00029 HUS', 'city': 'Helsinki', 'country': 'Finland', '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': 44.84124, 'lon': -0.58046}}, {'zip': '59500', 'city': 'Douai', 'country': 'France', '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': 50.37069, 'lon': 3.07922}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', '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': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', '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': 43.61093, 'lon': 3.87635}}, {'zip': '06200', 'city': 'Nice', 'country': 'France', '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': 43.70313, 'lon': 7.26608}}, {'zip': '44000', 'city': 'Orvault', 'country': 'France', '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': 47.27117, 'lon': -1.62361}}, {'zip': '22926', 'city': 'Ahrensburg', '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': 53.67661, 'lon': 10.23705}}, {'zip': 'D-14050', '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}}, {'zip': '44791', 'city': 'Bochum', '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': 51.48165, 'lon': 7.21648}}, {'zip': '73479', 'city': 'Ellwangen', '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': 48.96164, 'lon': 10.13173}}, {'zip': 'D-45147', 'city': 'Essen', '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': 51.45657, 'lon': 7.01228}}, {'zip': '79104', 'city': 'Freiburg im Breisgau', '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': 47.9959, 'lon': 7.85222}}, {'zip': '36037', 'city': 'Fulda', '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': 50.55162, 'lon': 9.67518}}, {'zip': '65589', 'city': 'Hadamar', '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': 50.44593, 'lon': 8.04253}}, {'zip': '58093', 'city': 'Hagen', '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': 51.36081, 'lon': 7.47168}}, {'zip': '22527', '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 - 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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': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', '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': 42.81687, 'lon': -1.64323}}, {'zip': '49021', 'city': 'Zamora', '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': 41.50633, 'lon': -5.74456}}, {'zip': 'SE 972 35', 'city': 'Luleå', 'country': 'Sweden', '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': 65.58415, 'lon': 22.15465}}, {'zip': '22361', 'city': 'Lund', 'country': 'Sweden', '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': 55.70584, 'lon': 13.19321}}, {'zip': '21135', 'city': 'Malmo', 'country': 'Sweden', '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': 55.60587, 'lon': 13.00073}}, {'zip': 'SE 351 88', 'city': 'Vaxjo', 'country': 'Sweden', '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': 56.87767, 'lon': 14.80906}}, {'zip': '1005', 'city': 'Lausanne', 'country': 'Switzerland', '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': 46.516, 'lon': 6.63282}}, {'zip': 'BN1 3RJ', 'city': 'Brighton', 'state': 'East Sussex', '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': 50.82838, 'lon': -0.13947}}, {'zip': 'RH20 4NQ', 'city': 'Storrington', 'state': 'West Sussex', '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': 50.91765, 'lon': -0.45473}}, {'zip': 'SE5 8AZ', 'city': '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}}], '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 - 5hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}