Viewing Study NCT01026818

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Ignite Creation Date: 2025-12-25 @ 4:40 AM
Ignite Modification Date: 2025-12-26 @ 3:42 AM
Study NCT ID: NCT01026818
Status: COMPLETED
Last Update Posted: 2014-01-14
First Post: 2009-12-03
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Study of Tadalafil After Radical Prostatectomy
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Portugal']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, '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': 'Screen - BNSRP', 'description': 'Had bilateral nerve-sparing radical prostatectomy (BNSRP) surgery during Screening Period.', 'otherNumAtRisk': 583, 'otherNumAffected': 114, 'seriousNumAtRisk': 583, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.', 'otherNumAtRisk': 139, 'otherNumAffected': 50, 'seriousNumAtRisk': 139, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.', 'otherNumAtRisk': 143, 'otherNumAffected': 52, 'seriousNumAtRisk': 143, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo (Double-Blind Period/Washout Period)', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.', 'otherNumAtRisk': 141, 'otherNumAffected': 40, 'seriousNumAtRisk': 141, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Tadalafil 5 mg OaD (Open-Label Period)', 'description': 'Tadalafil 5 mg OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.', 'otherNumAtRisk': 139, 'otherNumAffected': 11, 'seriousNumAtRisk': 139, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Tadalfil 20 mg PRN (Open-Label Period)', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.', 'otherNumAtRisk': 143, 'otherNumAffected': 18, 'seriousNumAtRisk': 143, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Placebo (Open-Label Period)', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.', 'otherNumAtRisk': 141, 'otherNumAffected': 9, 'seriousNumAtRisk': 141, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Androgen deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Autoimmune thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Hypoprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Eyelid pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Ocular discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Posterior capsule opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 583, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 141, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA(15.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}, {'value': '19.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.675', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.14', 'ciLowerLimit': '0.63', 'ciUpperLimit': '2.06', 'pValueComment': 'The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.', 'groupDescription': 'A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The logistic regression model included terms for treatment group, country, and age group.', 'testedNonInferiority': False}, {'pValue': '0.704', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.48', 'ciUpperLimit': '1.65', 'pValueComment': 'The Type I error was controlled for multiplicity using a Bonferroni-Hommel procedure. First the largest p-value for the odds ratio to placebo was tested at the 5% level and in case of no rejection the second p-value was tested at the 2.5% level.', 'groupDescription': 'A sample size of 412 randomized participants provided 84% power to detect a 20% difference in the proportions for the 3 treatment groups. The sample size allowed for a 20% withdrawal during the study.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The logistic regression model included terms for treatment group, country, and age group.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 10.5', 'description': 'Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurement at Month 10.5.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Month 9', 'categories': [{'measurements': [{'value': '25.2', 'groupId': 'OG000'}, {'value': '19.7', 'groupId': 'OG001'}, {'value': '14.2', 'groupId': 'OG002'}]}]}, {'title': 'Month 13.5', 'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000'}, {'value': '33.1', 'groupId': 'OG001'}, {'value': '27.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.15', 'ciLowerLimit': '1.16', 'ciUpperLimit': '3.99', 'pValueComment': 'P-value is for Month 9.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The logistic regression model included terms for treatment group, country, and age group.', 'testedNonInferiority': False}, {'pValue': '0.210', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.85', 'pValueComment': 'P-value is for Month 9.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The logistic regression model included terms for treatment group, country, and age group.', 'testedNonInferiority': False}, {'pValue': '0.273', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.28', 'pValueComment': 'P-value is for Month 13.5.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The logistic regression model included terms for treatment group, country, and age group.', 'testedNonInferiority': False}, {'pValue': '0.259', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '0.80', 'ciUpperLimit': '2.29', 'pValueComment': 'P-value is for Month 13.5.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The logistic regression model included terms for treatment group, country, and age group.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9 and Month 13.5', 'description': 'Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had IIEF-EF Total Scores measurements at Months 9 and 13.5.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Month 9', 'categories': [{'measurements': [{'value': '7.73', 'groupId': 'OG000', 'lowerLimit': '5.73', 'upperLimit': '9.73'}, {'value': '6.53', 'groupId': 'OG001', 'lowerLimit': '4.56', 'upperLimit': '8.50'}, {'value': '4.93', 'groupId': 'OG002', 'lowerLimit': '2.88', 'upperLimit': '6.98'}]}]}, {'title': 'Month 10.5', 'categories': [{'measurements': [{'value': '6.24', 'groupId': 'OG000', 'lowerLimit': '4.22', 'upperLimit': '8.25'}, {'value': '5.76', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': '7.73'}, {'value': '5.98', 'groupId': 'OG002', 'lowerLimit': '3.92', 'upperLimit': '8.03'}]}]}, {'title': 'Month 13.5', 'categories': [{'measurements': [{'value': '10.60', 'groupId': 'OG000', 'lowerLimit': '8.39', 'upperLimit': '12.80'}, {'value': '9.78', 'groupId': 'OG001', 'lowerLimit': '7.63', 'upperLimit': '11.92'}, {'value': '8.97', 'groupId': 'OG002', 'lowerLimit': '6.74', 'upperLimit': '11.21'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.80', 'ciLowerLimit': '0.76', 'ciUpperLimit': '4.83', 'pValueComment': 'P-value is for Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.118', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '3.60', 'pValueComment': 'P-value is for Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.802', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-1.79', 'ciUpperLimit': '2.31', 'pValueComment': 'P-value is for Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.04', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.830', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-2.23', 'ciUpperLimit': '1.79', 'pValueComment': 'P-value is for Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.184', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '4.03', 'pValueComment': 'P-value is for Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.22', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.500', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '-1.54', 'ciUpperLimit': '3.16', 'pValueComment': 'P-value is for Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.20', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Baseline), Months 9 and 10.5 and 13.5', 'description': 'Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF-EF Total Scores measurement at Months 9, 10.5 and 13.5.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Orgasmic function - Month 9', 'categories': [{'measurements': [{'value': '2.76', 'groupId': 'OG000', 'lowerLimit': '1.98', 'upperLimit': '3.55'}, {'value': '2.48', 'groupId': 'OG001', 'lowerLimit': '1.70', 'upperLimit': '3.26'}, {'value': '2.39', 'groupId': 'OG002', 'lowerLimit': '1.59', 'upperLimit': '3.19'}]}]}, {'title': 'Orgasmic function - Month 10.5', 'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000', 'lowerLimit': '2.13', 'upperLimit': '3.76'}, {'value': '2.48', 'groupId': 'OG001', 'lowerLimit': '1.68', 'upperLimit': '3.28'}, {'value': '2.48', 'groupId': 'OG002', 'lowerLimit': '1.66', 'upperLimit': '3.31'}]}]}, {'title': 'Orgasmic function - Month 13.5', 'categories': [{'measurements': [{'value': '3.57', 'groupId': 'OG000', 'lowerLimit': '2.75', 'upperLimit': '4.39'}, {'value': '2.90', 'groupId': 'OG001', 'lowerLimit': '2.10', 'upperLimit': '3.70'}, {'value': '3.42', 'groupId': 'OG002', 'lowerLimit': '2.59', 'upperLimit': '4.25'}]}]}, {'title': 'Sexual desire - Month 9', 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '1.12'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.18', 'upperLimit': '1.11'}, {'value': '0.63', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '1.11'}]}]}, {'title': 'Sexual desire - Month 10.5', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '1.07'}, {'value': '0.65', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '1.11'}, {'value': '0.55', 'groupId': 'OG002', 'lowerLimit': '0.08', 'upperLimit': '1.01'}]}]}, {'title': 'Sexual desire - Month 13.5', 'categories': [{'measurements': [{'value': '1.04', 'groupId': 'OG000', 'lowerLimit': '0.56', 'upperLimit': '1.52'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.42', 'upperLimit': '1.35'}, {'value': '0.95', 'groupId': 'OG002', 'lowerLimit': '0.46', 'upperLimit': '1.43'}]}]}, {'title': 'Intercourse satisfaction - Month 9', 'categories': [{'measurements': [{'value': '3.89', 'groupId': 'OG000', 'lowerLimit': '2.90', 'upperLimit': '4.88'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '2.52', 'upperLimit': '4.48'}, {'value': '2.96', 'groupId': 'OG002', 'lowerLimit': '1.95', 'upperLimit': '3.96'}]}]}, {'title': 'Intercourse satisfaction - Month 10.5', 'categories': [{'measurements': [{'value': '3.21', 'groupId': 'OG000', 'lowerLimit': '2.19', 'upperLimit': '4.22'}, {'value': '2.81', 'groupId': 'OG001', 'lowerLimit': '1.81', 'upperLimit': '3.81'}, {'value': '2.72', 'groupId': 'OG002', 'lowerLimit': '1.69', 'upperLimit': '3.75'}]}]}, {'title': 'Intercourse satisfaction - Month 13.5', 'categories': [{'measurements': [{'value': '4.70', 'groupId': 'OG000', 'lowerLimit': '3.65', 'upperLimit': '5.75'}, {'value': '4.08', 'groupId': 'OG001', 'lowerLimit': '3.05', 'upperLimit': '5.10'}, {'value': '4.14', 'groupId': 'OG002', 'lowerLimit': '3.08', 'upperLimit': '5.20'}]}]}, {'title': 'Overall satisfaction - Month 9', 'categories': [{'measurements': [{'value': '0.97', 'groupId': 'OG000', 'lowerLimit': '0.38', 'upperLimit': '1.56'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.35', 'upperLimit': '1.51'}, {'value': '0.78', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '1.38'}]}]}, {'title': 'Overall satisfaction - Month 10.5', 'categories': [{'measurements': [{'value': '0.64', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '1.23'}, {'value': '0.48', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '1.06'}, {'value': '0.72', 'groupId': 'OG002', 'lowerLimit': '0.12', 'upperLimit': '1.32'}]}]}, {'title': 'Overall satisfaction - Month 13.5', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '2.13'}, {'value': '1.57', 'groupId': 'OG001', 'lowerLimit': '0.96', 'upperLimit': '2.19'}, {'value': '1.52', 'groupId': 'OG002', 'lowerLimit': '0.88', 'upperLimit': '2.15'}]}]}], 'analyses': [{'pValue': '0.340', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '1.14', 'pValueComment': 'P-value is for orgasmic function - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.39', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.821', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.84', 'pValueComment': 'P-value is for orgasmic function - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.38', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.268', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '1.28', 'pValueComment': 'P-value is for orgasmic function - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.998', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.80', 'pValueComment': 'P-value is for orgasmic function - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.728', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.97', 'pValueComment': 'P-value is for orgasmic function - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.42', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.203', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.33', 'ciUpperLimit': '0.28', 'pValueComment': 'P-value is for orgasmic function - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.41', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.950', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.49', 'pValueComment': 'P-value is for sexual desire - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.950', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.48', 'pValueComment': 'P-value is for sexual desire - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.792', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.51', 'pValueComment': 'P-value is for sexual desire - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.631', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.55', 'pValueComment': 'P-value is for sexual desire - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.23', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.691', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.58', 'pValueComment': 'P-value is for sexual desire - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.801', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.41', 'pValueComment': 'P-value is for sexual desire - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.065', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '1.92', 'pValueComment': 'P-value is for intercourse satisfaction - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.50', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.274', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '1.51', 'pValueComment': 'P-value is for intercourse satisfaction - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.49', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.359', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '1.52', 'pValueComment': 'P-value is for intercourse satisfaction - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.53', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.863', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.93', 'ciUpperLimit': '1.11', 'pValueComment': 'P-value is for intercourse satisfaction - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.314', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '1.66', 'pValueComment': 'P-value is for intercourse satisfaction - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.56', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.910', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-1.13', 'ciUpperLimit': '1.01', 'pValueComment': 'P-value is for intercourse satisfaction - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.532', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.78', 'pValueComment': 'P-value is for overall satisfaction - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.620', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.73', 'pValueComment': 'P-value is for overall satisfaction - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.792', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.51', 'pValueComment': 'P-value is for overall satisfaction - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.30', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.410', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.34', 'pValueComment': 'P-value is for overall satisfaction - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.955', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.65', 'pValueComment': 'P-value is for overall satisfaction - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.868', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.70', 'pValueComment': 'P-value is for overall satisfaction - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.33', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Baseline), Months 9 and 10.5 and 13.5', 'description': 'Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had baseline and at least one post-baseline IIEF domain scores measurements at Months 9, 10.5 and 13.5.'}, {'type': 'SECONDARY', 'title': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Month 9', 'categories': [{'measurements': [{'value': '2.21', 'spread': '0.11', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '2.42'}, {'value': '2.11', 'groupId': 'OG001', 'lowerLimit': '1.92', 'upperLimit': '2.30'}, {'value': '1.88', 'groupId': 'OG002', 'lowerLimit': '1.67', 'upperLimit': '2.09'}]}]}, {'title': 'Month 13.5', 'categories': [{'measurements': [{'value': '2.54', 'groupId': 'OG000', 'lowerLimit': '2.31', 'upperLimit': '2.77'}, {'value': '2.38', 'groupId': 'OG001', 'lowerLimit': '2.17', 'upperLimit': '2.59'}, {'value': '2.25', 'groupId': 'OG002', 'lowerLimit': '2.03', 'upperLimit': '2.48'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.56', 'pValueComment': 'P-value is for Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.45', 'pValueComment': 'P-value is for Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.54', 'pValueComment': 'P-value is for Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.316', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.38', 'pValueComment': 'P-value is for Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Months 9 and 13.5', 'description': 'The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had EDITS mean scores measurements at Months 9 and 13.5.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Sexual relationship - Month 9', 'categories': [{'measurements': [{'value': '4.78', 'groupId': 'OG000', 'lowerLimit': '2.87', 'upperLimit': '6.68'}, {'value': '3.50', 'groupId': 'OG001', 'lowerLimit': '1.61', 'upperLimit': '5.38'}, {'value': '3.02', 'groupId': 'OG002', 'lowerLimit': '1.09', 'upperLimit': '4.95'}]}]}, {'title': 'Sexual relationship - Month 13.5', 'categories': [{'measurements': [{'value': '6.90', 'groupId': 'OG000', 'lowerLimit': '4.79', 'upperLimit': '9.00'}, {'value': '6.68', 'groupId': 'OG001', 'lowerLimit': '4.62', 'upperLimit': '8.74'}, {'value': '6.72', 'groupId': 'OG002', 'lowerLimit': '4.62', 'upperLimit': '8.83'}]}]}, {'title': 'Self-esteem - Month 9', 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '1.87'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '-0.29', 'upperLimit': '1.87'}, {'value': '0.51', 'groupId': 'OG002', 'lowerLimit': '-0.61', 'upperLimit': '1.62'}]}]}, {'title': 'Self-esteem - Month 13.5', 'categories': [{'measurements': [{'value': '1.67', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '2.81'}, {'value': '1.72', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '2.83'}, {'value': '1.62', 'groupId': 'OG002', 'lowerLimit': '0.47', 'upperLimit': '2.77'}]}]}], 'analyses': [{'pValue': '0.086', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '-0.25', 'ciUpperLimit': '3.76', 'pValueComment': 'P-value is for sexual relationship - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.637', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '-1.50', 'ciUpperLimit': '2.45', 'pValueComment': 'P-value is for sexual relationship - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.00', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.885', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '2.53', 'pValueComment': 'P-value is for sexual relationship - Month 13.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.20', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.972', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-2.34', 'ciUpperLimit': '2.25', 'pValueComment': 'P-value is for sexual relationship - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.17', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.621', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '1.36', 'pValueComment': 'P-value is for self-esteem - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.598', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.78', 'ciUpperLimit': '1.35', 'pValueComment': 'P-value is for self-esteem - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.54', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.923', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-1.10', 'ciUpperLimit': '1.21', 'pValueComment': 'P-value is for self-esteem - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.59', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.857', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '1.24', 'pValueComment': 'P-value is for self-esteem - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Baseline), Months 9 and 13.5', 'description': 'The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEAR scores measurement at Months 9 and 13.5.'}, {'type': 'SECONDARY', 'title': 'Global Assessment Questions (GAQ) Question 1 at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Very much better', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Much better', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'A little better', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}]}, {'title': 'A little worse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 9.'}, {'type': 'SECONDARY', 'title': 'Global Assessment Question (GAQ) Question 1 at Month 13.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Very much better', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'Much better', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'A little Better', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'A little worse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 13.5', 'description': 'GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had GAQ Q1 assessed at Month 13.5.'}, {'type': 'SECONDARY', 'title': 'Global Assessment Question (GAQ) Question 2 at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Very much better', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Much better', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'A little better', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'A little worse', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 9.'}, {'type': 'SECONDARY', 'title': 'Global Assessment Question (GAQ) Question 2 at Month 13.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Very much better', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}, {'title': 'Much better', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'A little better', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'A little worse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 13.5', 'description': 'GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had GAQ Q2 assessed at Month 13.5.'}, {'type': 'SECONDARY', 'title': 'Residual Erectile Function (REF) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'REF = 0', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}]}, {'title': 'REF = 1', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'REF = 2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'REF = 3', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'REF = 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had REF assessed at baseline.'}, {'type': 'SECONDARY', 'title': 'Residual Erectile Function (REF) at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 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[{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 2', 'description': 'The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had REF assessed at Month 2.'}, {'type': 'SECONDARY', 'title': 'Residual Erectile Function (REF) at Month 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}, {'value': '123', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 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{'title': 'Q5 - Month 10.5', 'categories': [{'measurements': [{'value': '16.26', 'groupId': 'OG000', 'lowerLimit': '9.21', 'upperLimit': '23.31'}, {'value': '10.52', 'groupId': 'OG001', 'lowerLimit': '3.85', 'upperLimit': '17.19'}, {'value': '19.11', 'groupId': 'OG002', 'lowerLimit': '12.00', 'upperLimit': '26.23'}]}]}, {'title': 'Q5 - Month 13.5', 'categories': [{'measurements': [{'value': '40.81', 'groupId': 'OG000', 'lowerLimit': '31.82', 'upperLimit': '49.81'}, {'value': '34.96', 'groupId': 'OG001', 'lowerLimit': '26.31', 'upperLimit': '43.62'}, {'value': '29.38', 'groupId': 'OG002', 'lowerLimit': '20.39', 'upperLimit': '38.37'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.87', 'ciLowerLimit': '3.92', 'ciUpperLimit': '25.83', 'pValueComment': 'P-value is for Q1 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.57', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.038', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.34', 'ciLowerLimit': '0.63', 'ciUpperLimit': '22.04', 'pValueComment': 'P-value is for Q1 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.45', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.148', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.91', 'ciLowerLimit': '-3.18', 'ciUpperLimit': '21.00', 'pValueComment': 'P-value is for Q1 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.15', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.373', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.37', 'ciLowerLimit': '-6.48', 'ciUpperLimit': '17.23', 'pValueComment': 'P-value is for Q1 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.03', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.90', 'ciLowerLimit': '1.14', 'ciUpperLimit': '20.66', 'pValueComment': 'P-value is for Q1 - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.96', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.357', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.53', 'ciLowerLimit': '-5.12', 'ciUpperLimit': '14.17', 'pValueComment': 'P-value is for Q1 - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.91', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.33', 'ciLowerLimit': '5.68', 'ciUpperLimit': '26.98', 'pValueComment': 'P-value is for Q2 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.42', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.212', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.62', 'ciLowerLimit': '-3.80', 'ciUpperLimit': '17.04', 'pValueComment': 'P-value is for Q2 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.30', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.461', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.55', 'ciLowerLimit': '-7.58', 'ciUpperLimit': '16.68', 'pValueComment': 'P-value is for Q2 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.17', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.835', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.26', 'ciLowerLimit': '-13.16', 'ciUpperLimit': '10.63', 'pValueComment': 'P-value is for Q2 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.030', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.36', 'ciLowerLimit': '1.27', 'ciUpperLimit': '25.46', 'pValueComment': 'P-value is for Q2 - Month13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.15', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.326', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.96', 'ciLowerLimit': '-5.97', 'ciUpperLimit': '17.89', 'pValueComment': 'P-value is for Q2 - Month13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.07', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '12.06', 'ciLowerLimit': '1.98', 'ciUpperLimit': '22.15', 'pValueComment': 'P-value is for Q3 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.621', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.48', 'ciLowerLimit': '-7.38', 'ciUpperLimit': '12.35', 'pValueComment': 'P-value is for Q3 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.02', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.968', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-11.03', 'ciUpperLimit': '11.49', 'pValueComment': 'P-value is for Q3 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.73', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.327', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.51', 'ciLowerLimit': '-16.55', 'ciUpperLimit': '5.54', 'pValueComment': 'P-value is for Q3 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.62', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.066', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.67', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '24.09', 'pValueComment': 'P-value is for Q3 - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.32', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.415', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.09', 'ciLowerLimit': '-7.17', 'ciUpperLimit': '17.34', 'pValueComment': 'P-value is for Q3 - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.23', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.011', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.87', 'ciLowerLimit': '2.79', 'ciUpperLimit': '20.94', 'pValueComment': 'P-value is for Q4 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.61', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.394', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.85', 'ciLowerLimit': '-5.03', 'ciUpperLimit': '12.72', 'pValueComment': 'P-value is for Q4 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.51', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.684', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.94', 'ciLowerLimit': '-11.28', 'ciUpperLimit': '7.41', 'pValueComment': 'P-value is for Q4 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.75', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.126', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.14', 'ciLowerLimit': '-16.30', 'ciUpperLimit': '2.02', 'pValueComment': 'P-value is for Q4 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.66', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.061', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.52', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '23.57', 'pValueComment': 'P-value is for Q4 - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.13', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.403', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.06', 'ciLowerLimit': '-6.83', 'ciUpperLimit': '16.95', 'pValueComment': 'P-value is for Q4 - Month13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '11.38', 'ciLowerLimit': '2.38', 'ciUpperLimit': '20.38', 'pValueComment': 'P-value is for Q5 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.58', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.410', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.69', 'ciLowerLimit': '-5.11', 'ciUpperLimit': '12.49', 'pValueComment': 'P-value is for Q5 - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.47', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.537', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.85', 'ciLowerLimit': '-11.92', 'ciUpperLimit': '6.22', 'pValueComment': 'P-value is for Q5 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.61', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.058', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.59', 'ciLowerLimit': '-17.48', 'ciUpperLimit': '0.30', 'pValueComment': 'P-value is for Q5 - Month 10.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.52', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.061', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.44', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '23.41', 'pValueComment': 'P-value is for Q5 - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.09', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.353', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.59', 'ciLowerLimit': '-6.23', 'ciUpperLimit': '17.40', 'pValueComment': 'P-value is for Q5 - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.01', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included terms for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Baseline), Months 9 and 10.5 and 13.5', 'description': "Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).", 'unitOfMeasure': 'percentage of "yes" responses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline SEP questions answered at Months 9, 10.5 and 13.5.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in 'Yes' Answers to Morning Erections", 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.92', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '16.39'}, {'value': '12.16', 'groupId': 'OG001', 'lowerLimit': '5.16', 'upperLimit': '19.16'}, {'value': '14.04', 'groupId': 'OG002', 'lowerLimit': '6.74', 'upperLimit': '21.35'}]}]}], 'analyses': [{'pValue': '0.162', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.12', 'ciLowerLimit': '-12.32', 'ciUpperLimit': '2.08', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.66', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included treatment, baseline, age group, and country.', 'testedNonInferiority': False}, {'pValue': '0.603', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciPctValue': '95', 'paramValue': '-1.88', 'ciLowerLimit': '-8.99', 'ciUpperLimit': '5.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.61', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included treatment, baseline, age group, and country.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Baseline), Month 10.5', 'description': 'The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant\'s percentage of "yes" responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.', 'unitOfMeasure': 'percentage of "yes" response', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had morning erection question answered at Baseline and Month 10.5.'}, {'type': 'SECONDARY', 'title': 'Standardized Morning Erections Question (SMEQ) Score at Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Yes, regularly', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Less frequently than in the past', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Only occasionally', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 2', 'description': 'Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 2'}, {'type': 'SECONDARY', 'title': 'Standardized Morning Erections Question (SMEQ) Score at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Yes, regularly', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Less frequently than in the past', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Only occasionally', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 9', 'description': 'Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 9.'}, {'type': 'SECONDARY', 'title': 'Standardized Morning Erections Question (SMEQ) Score at Month 13.5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Yes, regularly', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Less frequently than in the past', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Only occasionally', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Never', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 13.5', 'description': 'Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had SMEQ measurement at Month 13.5.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Urinary Incontinence - Month 9', 'categories': [{'measurements': [{'value': '34.08', 'groupId': 'OG000', 'lowerLimit': '29.31', 'upperLimit': '38.86'}, {'value': '31.12', 'groupId': 'OG001', 'lowerLimit': '26.74', 'upperLimit': '35.51'}, {'value': '30.59', 'groupId': 'OG002', 'lowerLimit': '25.85', 'upperLimit': '35.33'}]}]}, {'title': 'Urinary Incontinence - Month 13.5', 'categories': [{'measurements': [{'value': '37.41', 'groupId': 'OG000', 'lowerLimit': '32.56', 'upperLimit': '42.26'}, {'value': '35.54', 'groupId': 'OG001', 'lowerLimit': '31.10', 'upperLimit': '39.97'}, {'value': '35.44', 'groupId': 'OG002', 'lowerLimit': '30.65', 'upperLimit': '40.23'}]}]}, {'title': 'Urinary Irritative/Obstructive - Month 9', 'categories': [{'measurements': [{'value': '13.83', 'groupId': 'OG000', 'lowerLimit': '11.54', 'upperLimit': '16.12'}, {'value': '13.28', 'groupId': 'OG001', 'lowerLimit': '11.19', 'upperLimit': '15.37'}, {'value': '12.26', 'groupId': 'OG002', 'lowerLimit': '10.01', 'upperLimit': '14.51'}]}]}, {'title': 'Urinary Irritative/Obstructive - Month 13.5', 'categories': [{'measurements': [{'value': '13.86', 'groupId': 'OG000', 'lowerLimit': '11.53', 'upperLimit': '16.20'}, {'value': '13.82', 'groupId': 'OG001', 'lowerLimit': '11.70', 'upperLimit': '15.94'}, {'value': '12.30', 'groupId': 'OG002', 'lowerLimit': '0.01', 'upperLimit': '14.60'}]}]}, {'title': 'Bowel - Month 9', 'categories': [{'measurements': [{'value': '5.94', 'groupId': 'OG000', 'lowerLimit': '3.71', 'upperLimit': '8.17'}, {'value': '6.27', 'groupId': 'OG001', 'lowerLimit': '4.22', 'upperLimit': '8.33'}, {'value': '6.48', 'groupId': 'OG002', 'lowerLimit': '4.31', 'upperLimit': '8.65'}]}]}, {'title': 'Bowel - Month 13.5', 'categories': [{'measurements': [{'value': '6.87', 'groupId': 'OG000', 'lowerLimit': '4.67', 'upperLimit': '9.08'}, {'value': '6.49', 'groupId': 'OG001', 'lowerLimit': '4.46', 'upperLimit': '8.52'}, {'value': '6.78', 'groupId': 'OG002', 'lowerLimit': '4.61', 'upperLimit': '8.94'}]}]}, {'title': 'Sexual - Month 9', 'categories': [{'measurements': [{'value': '27.53', 'groupId': 'OG000', 'lowerLimit': '21.64', 'upperLimit': '33.42'}, {'value': '20.66', 'groupId': 'OG001', 'lowerLimit': '15.27', 'upperLimit': '26.06'}, {'value': '17.98', 'groupId': 'OG002', 'lowerLimit': '12.14', 'upperLimit': '23.81'}]}]}, {'title': 'Sexual - Month 13.5', 'categories': [{'measurements': [{'value': '36.55', 'groupId': 'OG000', 'lowerLimit': '30.03', 'upperLimit': '43.06'}, {'value': '32.58', 'groupId': 'OG001', 'lowerLimit': '26.60', 'upperLimit': '38.56'}, {'value': '33.37', 'groupId': 'OG002', 'lowerLimit': '26.95', 'upperLimit': '39.79'}]}]}, {'title': 'Hormonal - Month 9', 'categories': [{'measurements': [{'value': '1.72', 'groupId': 'OG000', 'lowerLimit': '-0.81', 'upperLimit': '4.26'}, {'value': '2.72', 'groupId': 'OG001', 'lowerLimit': '0.36', 'upperLimit': '5.08'}, {'value': '-0.18', 'groupId': 'OG002', 'lowerLimit': '-2.67', 'upperLimit': '2.31'}]}]}, {'title': 'Hormonal - Month 13.5', 'categories': [{'measurements': [{'value': '2.48', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '4.87'}, {'value': '2.92', 'groupId': 'OG001', 'lowerLimit': '0.76', 'upperLimit': '5.08'}, {'value': '3.01', 'groupId': 'OG002', 'lowerLimit': '0.67', 'upperLimit': '5.36'}]}]}], 'analyses': [{'pValue': '0.196', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.49', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '8.80', 'pValueComment': 'P-value is for Urinary Incontinence - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.70', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, 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'pValueComment': 'P-value is for Urinary Incontinence - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.76', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.971', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-5.21', 'ciUpperLimit': '5.41', 'pValueComment': 'P-value is for Urinary Incontinence - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.70', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.236', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.57', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '4.17', 'pValueComment': 'P-value is for Urinary Irritative/Obstructive - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.32', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.429', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '3.56', 'pValueComment': 'P-value is for Urinary Irritative/Obstructive - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.252', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '4.24', 'pValueComment': 'P-value is for Urinary Irritative/Obstructive - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.36', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.251', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '4.11', 'pValueComment': 'P-value is for Urinary Irritative/Obstructive - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.32', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.671', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-3.03', 'ciUpperLimit': '1.95', 'pValueComment': 'P-value is for Bowel - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.27', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.868', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-2.64', 'ciUpperLimit': '2.23', 'pValueComment': 'P-value is for Bowel - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.24', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.938', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '2.57', 'pValueComment': 'P-value is for Bowel - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.25', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.813', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-2.69', 'ciUpperLimit': '2.12', 'pValueComment': 'P-value is for Bowel - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.22', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.55', 'ciLowerLimit': '3.10', 'ciUpperLimit': '15.99', 'pValueComment': 'P-value is for Sexual - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.28', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.403', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.69', 'ciLowerLimit': '-3.63', 'ciUpperLimit': '9.00', 'pValueComment': 'P-value is for Sexual - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.21', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.406', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.18', 'ciLowerLimit': '-4.34', 'ciUpperLimit': '10.69', 'pValueComment': 'P-value is for Sexual - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.82', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.832', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.79', 'ciLowerLimit': '-8.11', 'ciUpperLimit': '6.53', 'pValueComment': 'P-value is for Sexual - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.72', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.197', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.90', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '4.79', 'pValueComment': 'P-value is for Hormonal - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.47', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.045', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.89', 'ciLowerLimit': '0.06', 'ciUpperLimit': '5.72', 'pValueComment': 'P-value is for Hormonal - Month 9.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.44', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.692', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.53', 'ciLowerLimit': '-3.16', 'ciUpperLimit': '2.10', 'pValueComment': 'P-value is for Hormonal - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.34', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}, {'pValue': '0.943', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-2.65', 'ciUpperLimit': '2.46', 'pValueComment': 'P-value is for Hormonal - Month 13.5.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.30', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The MMRM model included baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Baseline), Months 9 and 13.5', 'description': 'EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug, had baseline and at least 1 post-baseline EPIC-26 scores measurement at Month 9 and Month 13.5.'}, {'type': 'SECONDARY', 'title': 'Change in Penile Length and Girth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'classes': [{'title': 'Length', 'categories': [{'measurements': [{'value': '-1.53', 'groupId': 'OG000', 'lowerLimit': '-5.54', 'upperLimit': '2.47'}, {'value': '-7.26', 'groupId': 'OG001', 'lowerLimit': '-11.04', 'upperLimit': '-3.49'}, {'value': '-5.73', 'groupId': 'OG002', 'lowerLimit': '-9.68', 'upperLimit': '-1.78'}]}]}, {'title': 'Girth', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-3.09', 'upperLimit': '3.15'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '-2.11', 'upperLimit': '3.75'}, {'value': '-2.34', 'groupId': 'OG002', 'lowerLimit': '-5.43', 'upperLimit': '0.75'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.20', 'ciLowerLimit': '0.47', 'ciUpperLimit': '7.93', 'pValueComment': 'P-value is for length.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.89', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline, age group and country.', 'testedNonInferiority': False}, {'pValue': '0.413', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.53', 'ciLowerLimit': '-5.20', 'ciUpperLimit': '2.14', 'pValueComment': 'P-value is for length.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.87', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline, age group and country.', 'testedNonInferiority': False}, {'pValue': '0.112', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.37', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '5.30', 'pValueComment': 'P-value is for girth.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline, age group and country.', 'testedNonInferiority': False}, {'pValue': '0.031', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Differences', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.16', 'ciLowerLimit': '0.29', 'ciUpperLimit': '6.03', 'pValueComment': 'P-value is for girth.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.46', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA model included terms for treatment, baseline, age group and country.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Randomization (Baseline), Month 9', 'description': 'Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.', 'unitOfMeasure': 'millimeter (mm)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study drug and had penile measurements at Baseline and Month 9.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Screen - BNSRP', 'description': 'BNSRP surgery during Screening Period.'}, {'id': 'FG001', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'FG002', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}], 'periods': [{'title': 'Screening Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '583'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '423'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'DB Treatment Period (Month 0 - 9)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '143'}, {'groupId': 'FG003', 'numSubjects': '141'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '143'}, {'groupId': 'FG003', 'numSubjects': '141'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '122'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}, {'title': 'Drug-Free Washout Period (Month 9-10.5)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '122'}, {'groupId': 'FG003', 'numSubjects': '115'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'OL Period (Month 10.5 - 13.5)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '117'}, {'groupId': 'FG003', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '112'}, {'groupId': 'FG003', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study consisted of a 6-week screening period including the time of bilateral nerve-sparing radical prostatectomy (BNSRP) surgery, a 9-month, randomized Double-Blind (DB), Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label (OL) Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '423', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tadalafil 5 mg OaD', 'description': 'Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'BG001', 'title': 'Tadalafil 20 mg PRN', 'description': 'Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'spread': '5.07', 'groupId': 'BG000'}, {'value': '57.5', 'spread': '5.91', 'groupId': 'BG001'}, {'value': '57.6', 'spread': '5.69', 'groupId': 'BG002'}, {'value': '57.9', 'spread': '5.58', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '423', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '416', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized participants who received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 583}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-12', 'studyFirstSubmitDate': '2009-12-03', 'resultsFirstSubmitDate': '2013-09-10', 'studyFirstSubmitQcDate': '2009-12-03', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-10', 'studyFirstPostDateStruct': {'date': '2009-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire', 'timeFrame': 'Month 10.5', 'description': 'Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain', 'timeFrame': 'Month 9 and Month 13.5', 'description': 'Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants with an IIEF-EF Total Score greater than or equal to (≥) 22.'}, {'measure': 'Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score', 'timeFrame': 'Randomization (Baseline), Months 9 and 10.5 and 13.5', 'description': 'Self-reported erectile function during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).'}, {'measure': 'Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)', 'timeFrame': 'Randomization (Baseline), Months 9 and 10.5 and 13.5', 'description': 'Self-reported overall satisfaction during past 4 weeks. Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF. Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF. Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF. Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function. MMRM analysis was used to calculate LS mean and 95% CI. LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).'}, {'measure': 'Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score', 'timeFrame': 'Months 9 and 13.5', 'description': 'The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment. Responses were based on the experiences during the previous 4 weeks. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered. The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction). The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).'}, {'measure': 'Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score', 'timeFrame': 'Randomization (Baseline), Months 9 and 13.5', 'description': 'The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED). It consists of 14 items. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship. Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem). Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).'}, {'measure': 'Global Assessment Questions (GAQ) Question 1 at Month 9', 'timeFrame': 'Month 9', 'description': 'GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).'}, {'measure': 'Global Assessment Question (GAQ) Question 1 at Month 13.5', 'timeFrame': 'Month 13.5', 'description': 'GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).'}, {'measure': 'Global Assessment Question (GAQ) Question 2 at Month 9', 'timeFrame': 'Month 9', 'description': 'GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).'}, {'measure': 'Global Assessment Question (GAQ) Question 2 at Month 13.5', 'timeFrame': 'Month 13.5', 'description': 'GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from very much better (1) to very much worse (7).'}, {'measure': 'Residual Erectile Function (REF) at Baseline', 'timeFrame': 'Baseline', 'description': 'The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)'}, {'measure': 'Residual Erectile Function (REF) at Month 2', 'timeFrame': 'Month 2', 'description': 'The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)'}, {'measure': 'Residual Erectile Function (REF) at Month 5', 'timeFrame': 'Month 5', 'description': 'The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)'}, {'measure': 'Residual Erectile Function (REF) at Month 9', 'timeFrame': 'Month 9', 'description': 'The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)'}, {'measure': 'Residual Erectile Function (REF) at Month 10.5', 'timeFrame': 'Month 10.5', 'description': 'The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)'}, {'measure': 'Residual Erectile Function (REF) at Month 13.5', 'timeFrame': 'Month 13.5', 'description': 'The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)'}, {'measure': "Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)", 'timeFrame': 'Randomization (Baseline), Months 9 and 10.5 and 13.5', 'description': "Participant-assessed diary has 5 questions: Question (Q)1: erection achievement, Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10)."}, {'measure': "Change From Baseline in 'Yes' Answers to Morning Erections", 'timeFrame': 'Randomization (Baseline), Month 10.5', 'description': 'The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period. Data presented are the changes in the participant\'s percentage of "yes" responses relative to the number of days the question was answered during treatment. The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.'}, {'measure': 'Standardized Morning Erections Question (SMEQ) Score at Month 2', 'timeFrame': 'Month 2', 'description': 'Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).'}, {'measure': 'Standardized Morning Erections Question (SMEQ) Score at Month 9', 'timeFrame': 'Month 9', 'description': 'Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).'}, {'measure': 'Standardized Morning Erections Question (SMEQ) Score at Month 13.5', 'timeFrame': 'Month 13.5', 'description': 'Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).'}, {'measure': 'Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score', 'timeFrame': 'Randomization (Baseline), Months 9 and 13.5', 'description': 'EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life. Responses are based on experiences during the previous 4 weeks. The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p\\<0.10).'}, {'measure': 'Change in Penile Length and Girth', 'timeFrame': 'Randomization (Baseline), Month 9', 'description': 'Measurements were performed with the penis in the flaccid state. The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis. The penile circumference at midshaft was measured. All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm). The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI). LS mean values are adjusted for treatment, baseline, age group and country.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Erectile Dysfunction', 'Radical Prostatectomy'], 'conditions': ['Erectile Dysfunction']}, 'referencesModule': {'references': [{'pmid': '26947602', 'type': 'DERIVED', 'citation': "Montorsi F, Oelke M, Henneges C, Brock G, Salonia A, d'Anzeo G, Rossi A, Mulhall JP, Buttner H. Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy. Eur Urol. 2016 Sep;70(3):529-37. doi: 10.1016/j.eururo.2016.02.036. Epub 2016 Mar 3."}, {'pmid': '25879460', 'type': 'DERIVED', 'citation': 'Patel HR, Ilo D, Shah N, Cuzin B, Chadwick D, Andrianne R, Henneges C, Barry J, Hell-Momeni K, Branicka J, Buttner H. Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study. BMC Urol. 2015 Apr 12;15:31. doi: 10.1186/s12894-015-0022-9.'}, {'pmid': '24169081', 'type': 'DERIVED', 'citation': 'Montorsi F, Brock G, Stolzenburg JU, Mulhall J, Moncada I, Patel HR, Chevallier D, Krajka K, Henneges C, Dickson R, Buttner H. Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Eur Urol. 2014 Mar;65(3):587-96. doi: 10.1016/j.eururo.2013.09.051. Epub 2013 Oct 13.'}]}, 'descriptionModule': {'briefSummary': 'The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy. Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo. Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication). An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day. Further objectives are to evaluate the treatment satisfaction of the respective therapies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer\n* have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF))\n* develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery\n* have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study\n* agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study\n* does not require the initiation of adjuvant therapy for prostate cancer\n\nExclusion Criteria:\n\n* history of ED\n* have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor\n* have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer\n* have a history of prostatic surgery or prostatic physical treatments\n* have a history of diabetes mellitus\n* have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption\n* have clinically significant renal insufficiency as determined by the investigator'}, 'identificationModule': {'nctId': 'NCT01026818', 'acronym': 'REACTT', 'briefTitle': 'A Study of Tadalafil After Radical Prostatectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy', 'orgStudyIdInfo': {'id': '13086'}, 'secondaryIdInfos': [{'id': 'H6D-EW-LVIK', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tadalafil daily [5 milligrams (mg)]', 'description': 'After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'EXPERIMENTAL', 'label': 'Tadalafil on demand (20 mg)', 'description': 'After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.', 'interventionNames': ['Drug: Tadalafil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tadalafil', 'type': 'DRUG', 'otherNames': ['Cialis', 'LY450190'], 'description': 'Administered by mouth for 9 months', 'armGroupLabels': ['Tadalafil daily [5 milligrams (mg)]', 'Tadalafil on demand (20 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered by mouth, daily or on demand for 9 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8500', 'city': 'Kortrijk', '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': 50.82803, 'lon': 3.26487}}, {'zip': '3000', 'city': 'Leuven', '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': 50.87959, 'lon': 4.70093}}, {'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': 'T2W 1P9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V8T 5G1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '94010', 'city': 'Créteil', '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': 48.79266, 'lon': 2.46569}}, {'zip': '38043', 'city': 'Grenoble', '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': 45.17869, 'lon': 5.71479}}, {'zip': '69437', 'city': 'Lyon', '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': 45.74906, 'lon': 4.84789}}, {'zip': '06002', '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': '30029', 'city': 'Nîmes', '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': 43.83665, 'lon': 4.35788}}, {'zip': '69495', 'city': 'Pierre-Bénite', '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': 45.70359, 'lon': 4.82424}}, {'zip': '12203', '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': '38126', 'city': 'Braunschweig', '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': 52.26594, 'lon': 10.52673}}, {'zip': '01307', 'city': 'Dresden', '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': 51.05089, 'lon': 13.73832}}, {'zip': '45122', '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': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', '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': 52.37052, 'lon': 9.73322}}, {'zip': '44627', 'city': 'Herne', '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': 51.5388, 'lon': 7.22572}}, {'zip': '04103', 'city': 'Leipzig', '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': 51.33962, 'lon': 12.37129}}, {'zip': '51375', 'city': 'Leverkusen', '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': 51.0303, 'lon': 6.98432}}, {'zip': '70021', 'city': 'Acquavivadellefonti', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '24128', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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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': 52.22977, 'lon': 21.01178}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', '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': 50.32492, 'lon': 18.78576}}, {'zip': '28023', 'city': 'Aravaca', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.45772, 'lon': -3.78282}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.71667, 'lon': -2.6}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}