Viewing Study NCT03100058


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Ignite Modification Date: 2026-06-17 @ 7:47 PM
Study NCT ID: NCT03100058
Status: COMPLETED
Last Update Posted: 2020-02-06
First Post: 2017-03-03
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000709456', 'term': 'licogliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to maximum duration of approximately 15 months.', 'description': 'Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'LIK066 2.5 mg qd (Epoch 3)/25 mg qd (Epoch 4)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks (Epoch3), then LIK066 25 mg qd for 24 weeks (Epoch 4)', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 33, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'LIK066 10 mg qd/25 mg qd', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 24, 'seriousNumAtRisk': 38, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'LIK066 50 mg qd/25 mg qd', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 24, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'LIK066 150 mg qd/25 mg qd', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 55, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'LIK066 2.5 mg Bid/35 mg qd', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 31, 'seriousNumAtRisk': 38, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'LIK066 5 mg Bid/35 mg qd', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 32, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG006', 'title': 'LIK066 25 mg Bid/35 mg qd', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 26, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'LIK066 50 mg Bid/35 mg qd', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 47, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Placebo/LIK066 25 mg qd (Epoch 4)', 'description': 'Matching placebo tablets for 24 weeks', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 32, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Placebo/Placebo', 'description': 'Matching placebo tablets', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 32, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Microvascular coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Porokeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Type IIa hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Inner ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 38, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 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'groupDescription': '\\>=5%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '<.001', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.57', 'ciLowerLimit': '2.41', 'ciUpperLimit': '12.88', 'groupDescription': '\\>=5%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.812', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.36', 'ciUpperLimit': '3.74', 'groupDescription': '\\>=5%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.229', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.94', 'ciLowerLimit': '0.66', 'ciUpperLimit': '5.69', 'groupDescription': '\\>=5%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.004', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.29', 'ciLowerLimit': '1.61', 'ciUpperLimit': '11.46', 'groupDescription': '\\>=5%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '<.001', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.37', 'ciLowerLimit': '2.72', 'ciUpperLimit': '14.93', 'groupDescription': '\\>=5%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.943', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.10', 'ciUpperLimit': '12.41', 'groupDescription': '\\>=10%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.465', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.11', 'ciLowerLimit': '0.28', 'ciUpperLimit': '15.77', 'groupDescription': '\\>=10%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.696', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '0.15', 'ciUpperLimit': '17.15', 'groupDescription': '\\>=10%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.389', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.14', 'ciLowerLimit': '0.38', 'ciUpperLimit': '12.10', 'groupDescription': '\\>=10%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.976', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.09', 'ciUpperLimit': '11.87', 'groupDescription': '\\>=10%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.986', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.09', 'ciUpperLimit': '11.70', 'groupDescription': '\\>=10%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.181', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.51', 'ciLowerLimit': '0.56', 'ciUpperLimit': '22.18', 'groupDescription': '\\>=10%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.100', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.97', 'ciLowerLimit': '0.77', 'ciUpperLimit': '20.54', 'groupDescription': '\\>=10%', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}], 'classes': [{'title': 'Dysglycemic (>=5%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '31', 'groupId': 'OG007'}, {'value': '31', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '40.0', 'groupId': 'OG002'}, {'value': '48.4', 'groupId': 'OG003'}, {'value': '6.7', 'groupId': 'OG004'}, {'value': '37.5', 'groupId': 'OG005'}, {'value': '40.0', 'groupId': 'OG006'}, {'value': '41.9', 'groupId': 'OG007'}, {'value': '9.7', 'groupId': 'OG008'}]}]}, {'title': 'Normoglycemic (>=5%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '17', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}, {'value': '44.4', 'groupId': 'OG002'}, {'value': '47.4', 'groupId': 'OG003'}, {'value': '11.1', 'groupId': 'OG004'}, {'value': '11.1', 'groupId': 'OG005'}, {'value': '55.6', 'groupId': 'OG006'}, {'value': '52.9', 'groupId': 'OG007'}, {'value': '20.0', 'groupId': 'OG008'}]}]}, {'title': 'Type 2 Diabetes Mellitus (T2DM) (>=5%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '27', 'groupId': 'OG007'}, {'value': '27', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '15.4', 'groupId': 'OG001'}, {'value': '28.6', 'groupId': 'OG002'}, {'value': '37.0', 'groupId': 'OG003'}, {'value': '28.6', 'groupId': 'OG004'}, {'value': '14.3', 'groupId': 'OG005'}, {'value': '30.8', 'groupId': 'OG006'}, {'value': '44.4', 'groupId': 'OG007'}, {'value': '14.8', 'groupId': 'OG008'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.29', 'ciLowerLimit': '1.02', 'ciUpperLimit': '38.76', 'groupDescription': '\\>=5% (Dysglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.171', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Odds Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.94', 'ciLowerLimit': '0.55', 'ciUpperLimit': '28.03', 'groupDescription': '\\>=5% (Dsyglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.041', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.17', 'ciLowerLimit': '1.09', 'ciUpperLimit': '47.27', 'groupDescription': '\\>=5% (Dysglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.003', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.89', 'ciLowerLimit': '2.32', 'ciUpperLimit': '60.93', 'groupDescription': '\\>=5% (Dysglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.976', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.08', 'ciUpperLimit': '11.72', 'groupDescription': '\\>=5% (Dysglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.022', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.78', 'ciLowerLimit': '1.37', 'ciUpperLimit': '56.44', 'groupDescription': '\\>=5% (Dysglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.032', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.50', 'ciLowerLimit': '1.20', 'ciUpperLimit': '46.99', 'groupDescription': '\\>=5% (Dysglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.005', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.28', 'ciLowerLimit': '2.11', 'ciUpperLimit': '60.46', 'groupDescription': '\\>=5% (Dysglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.227', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.21', 'ciLowerLimit': '0.48', 'ciUpperLimit': '21.28', 'groupDescription': '\\>=5% (Normoglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.763', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.06', 'ciUpperLimit': '7.85', 'groupDescription': '\\>=5% (Normoglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.095', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.68', 'ciLowerLimit': '0.76', 'ciUpperLimit': '28.70', 'groupDescription': '\\>=5% (Normoglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.033', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.33', 'ciLowerLimit': '1.14', 'ciUpperLimit': '24.83', 'groupDescription': '\\>=5% (Normoglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.788', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.06', 'ciUpperLimit': '8.10', 'groupDescription': '\\>=5% (Normoglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.751', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.68', 'ciLowerLimit': '0.06', 'ciUpperLimit': '7.62', 'groupDescription': '\\>=5% (Normoglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.027', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.05', 'ciLowerLimit': '1.27', 'ciUpperLimit': '51.09', 'groupDescription': '\\>=5% (Normoglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.023', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.64', 'ciLowerLimit': '1.30', 'ciUpperLimit': '34.00', 'groupDescription': '\\>=5% (Normoglycemic)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.528', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.05', 'ciUpperLimit': '4.78', 'groupDescription': '\\>=5% (T2DM)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.958', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.17', 'ciUpperLimit': '6.68', 'groupDescription': '\\>=5% (T2DM)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.546', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.70', 'ciLowerLimit': '0.30', 'ciUpperLimit': '9.49', 'groupDescription': '\\>=5% (T2DM)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.098', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.09', 'ciLowerLimit': '0.81', 'ciUpperLimit': '11.75', 'groupDescription': '\\>=5% (T2DM)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding test'}, {'pValue': '0.563', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.64', 'ciLowerLimit': '0.31', 'ciUpperLimit': '8.70', 'groupDescription': '\\>=5% (T2DM)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.610', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.06', 'ciUpperLimit': '5.38', 'groupDescription': '\\>=5% (T2DM)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.528', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.71', 'ciLowerLimit': '0.32', 'ciUpperLimit': '9.16', 'groupDescription': '\\>=5% (T2DM)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.023', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.55', 'ciLowerLimit': '1.23', 'ciUpperLimit': '16.90', 'groupDescription': '\\>=5% (T2DM)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 24', 'description': 'Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline on Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '163', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'OG009', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG010', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG011', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG012', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-3.87', 'upperLimit': '-0.31'}, {'value': '-2.7', 'groupId': 'OG001', 'lowerLimit': '-4.55', 'upperLimit': '-0.92'}, {'value': '-3.7', 'groupId': 'OG002', 'lowerLimit': '-5.55', 'upperLimit': '-1.82'}, {'value': '-5.6', 'groupId': 'OG003', 'lowerLimit': '-6.84', 'upperLimit': '-4.35'}, {'value': '-2.7', 'groupId': 'OG004', 'lowerLimit': '-4.47', 'upperLimit': '-0.91'}, {'value': '-4.3', 'groupId': 'OG005', 'lowerLimit': '-6.07', 'upperLimit': '-2.57'}, {'value': '-4.8', 'groupId': 'OG006', 'lowerLimit': '-6.61', 'upperLimit': '-2.98'}, {'value': '-4.6', 'groupId': 'OG007', 'lowerLimit': '-5.89', 'upperLimit': '-3.31'}, {'value': '-1.3', 'groupId': 'OG008', 'lowerLimit': '-2.54', 'upperLimit': '-0.05'}, {'value': '-0.4', 'groupId': 'OG009', 'lowerLimit': '-1.25', 'upperLimit': '0.36'}, {'value': '-0.7', 'groupId': 'OG010', 'lowerLimit': '-1.53', 'upperLimit': '0.10'}, {'value': '-2.1', 'groupId': 'OG011', 'lowerLimit': '-3.73', 'upperLimit': '-0.38'}, {'value': '0.4', 'groupId': 'OG012', 'lowerLimit': '-1.37', 'upperLimit': '2.20'}]}]}], 'analyses': [{'pValue': '0.470', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-2.96', 'ciUpperLimit': '1.37', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.199', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.64', 'ciUpperLimit': '0.76', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '<0.001', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.64', 'ciUpperLimit': '0.76', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.206', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.56', 'ciUpperLimit': '0.77', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.006', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-5.18', 'ciUpperLimit': '-0.88', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.002', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5', 'ciLowerLimit': '-5.70', 'ciUpperLimit': '-1.30', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '<0.001', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.3', 'ciLowerLimit': '-5.10', 'ciUpperLimit': '-1.51', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.391', 'groupIds': ['OG009', 'OG012'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.82', 'ciUpperLimit': '1.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.259', 'groupIds': ['OG010', 'OG012'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-3.10', 'ciUpperLimit': '0.84', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.048', 'groupIds': ['OG011', 'OG012'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-4.91', 'ciUpperLimit': '-0.02', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)', 'description': 'Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.', 'unitOfMeasure': 'Percentage Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '163', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'OG009', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG010', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG011', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG012', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '3.19'}, {'value': '-0.1', 'groupId': 'OG001', 'lowerLimit': '-1.46', 'upperLimit': '1.27'}, {'value': '-1.2', 'groupId': 'OG002', 'lowerLimit': '-2.60', 'upperLimit': '0.26'}, {'value': '-0.8', 'groupId': 'OG003', 'lowerLimit': '-1.70', 'upperLimit': '0.16'}, {'value': '-0.5', 'groupId': 'OG004', 'lowerLimit': '-1.80', 'upperLimit': '0.86'}, {'value': '-1.1', 'groupId': 'OG005', 'lowerLimit': '-2.37', 'upperLimit': '0.27'}, {'value': '-0.9', 'groupId': 'OG006', 'lowerLimit': '-2.28', 'upperLimit': '0.46'}, {'value': '-1.0', 'groupId': 'OG007', 'lowerLimit': '-1.96', 'upperLimit': '-0.13'}, {'value': '0.9', 'groupId': 'OG008', 'lowerLimit': '-0.06', 'upperLimit': '1.81'}, {'value': '-0.1', 'groupId': 'OG009', 'lowerLimit': '-0.64', 'upperLimit': '0.35'}, {'value': '-0.3', 'groupId': 'OG010', 'lowerLimit': '-0.79', 'upperLimit': '0.22'}, {'value': '-0.1', 'groupId': 'OG011', 'lowerLimit': '-1.14', 'upperLimit': '0.84'}, {'value': '0.6', 'groupId': 'OG012', 'lowerLimit': '-0.54', 'upperLimit': '1.73'}]}]}], 'analyses': [{'pValue': '0.225', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '2.61', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.247', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.62', 'ciUpperLimit': '0.68', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.019', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-3.75', 'ciUpperLimit': '-0.34', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.015', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-2.96', 'ciUpperLimit': '-0.33', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.106', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.97', 'ciUpperLimit': '0.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.020', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.54', 'ciUpperLimit': '-0.31', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.035', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-3.44', 'ciUpperLimit': '-0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.004', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-3.22', 'ciUpperLimit': '-0.61', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)', 'description': 'FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '163', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'OG009', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG010', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG011', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG012', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-0.23', 'upperLimit': '0.45'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '-0.13'}, {'value': '-0.9', 'groupId': 'OG002', 'lowerLimit': '-1.24', 'upperLimit': '-0.50'}, {'value': '-0.7', 'groupId': 'OG003', 'lowerLimit': '-0.92', 'upperLimit': '-0.44'}, {'value': '-0.3', 'groupId': 'OG004', 'lowerLimit': '-0.68', 'upperLimit': '0.00'}, {'value': '-0.5', 'groupId': 'OG005', 'lowerLimit': '-0.83', 'upperLimit': '-0.15'}, {'value': '-0.6', 'groupId': 'OG006', 'lowerLimit': '-0.98', 'upperLimit': '-0.28'}, {'value': '-0.6', 'groupId': 'OG007', 'lowerLimit': '-0.87', 'upperLimit': '-0.40'}, {'value': '-0.3', 'groupId': 'OG008', 'lowerLimit': '-0.50', 'upperLimit': '-0.02'}, {'value': '0.2', 'groupId': 'OG009', 'lowerLimit': '0.03', 'upperLimit': '0.38'}, {'value': '0.0', 'groupId': 'OG010', 'lowerLimit': '-0.13', 'upperLimit': '0.22'}, {'value': '-0.1', 'groupId': 'OG011', 'lowerLimit': '-0.49', 'upperLimit': '0.24'}, {'value': '0.3', 'groupId': 'OG012', 'lowerLimit': '-0.07', 'upperLimit': '0.71'}]}]}], 'analyses': [{'pValue': '0.082', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.79', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.319', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '0.21', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.008', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '-0.16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.015', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '-0.08', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.707', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.50', 'ciUpperLimit': '0.34', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.280', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.19', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.086', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.030', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '-0.04', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)', 'description': 'HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '163', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'OG009', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG010', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG011', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG012', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'title': 'systolic blood pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '58', 'groupId': 'OG009'}, {'value': '162', 'groupId': 'OG010'}, {'value': '37', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-4.38', 'upperLimit': '1.93'}, {'value': '-1.5', 'groupId': 'OG001', 'lowerLimit': '-4.38', 'upperLimit': '1.93'}, {'value': '-4.9', 'groupId': 'OG002', 'lowerLimit': '-8.30', 'upperLimit': '-1.52'}, {'value': '-1.2', 'groupId': 'OG003', 'lowerLimit': '-3.38', 'upperLimit': '1.06'}, {'value': '-0.7', 'groupId': 'OG004', 'lowerLimit': '-3.86', 'upperLimit': '2.43'}, {'value': '0.8', 'groupId': 'OG005', 'lowerLimit': '-2.38', 'upperLimit': '3.88'}, {'value': '-2.6', 'groupId': 'OG006', 'lowerLimit': '-5.82', 'upperLimit': '0.69'}, {'value': '-1.8', 'groupId': 'OG007', 'lowerLimit': '-4.15', 'upperLimit': '0.48'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '-0.67', 'upperLimit': '3.80'}, {'value': '-0.9', 'groupId': 'OG009', 'lowerLimit': '-2.66', 'upperLimit': '0.79'}, {'value': '-1.6', 'groupId': 'OG010', 'lowerLimit': '-3.39', 'upperLimit': '0.10'}, {'value': '-5.6', 'groupId': 'OG011', 'lowerLimit': '-9.22', 'upperLimit': '-2.06'}, {'value': '0.8', 'groupId': 'OG012', 'lowerLimit': '-2.97', 'upperLimit': '4.65'}]}]}, {'title': 'diastolic blood pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '162', 'groupId': 'OG010'}, {'value': '37', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-2.37', 'upperLimit': '2.00'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-2.21', 'upperLimit': '2.40'}, {'value': '-2.3', 'groupId': 'OG002', 'lowerLimit': '-4.62', 'upperLimit': '0.07'}, {'value': '-1.3', 'groupId': 'OG003', 'lowerLimit': '-2.82', 'upperLimit': '0.26'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '-1.35', 'upperLimit': '3.02'}, {'value': '-1.4', 'groupId': 'OG005', 'lowerLimit': '-3.57', 'upperLimit': '0.78'}, {'value': '0.3', 'groupId': 'OG006', 'lowerLimit': '-1.99', 'upperLimit': '2.54'}, {'value': '-1.7', 'groupId': 'OG007', 'lowerLimit': '-3.26', 'upperLimit': '-0.06'}, {'value': '0.5', 'groupId': 'OG008', 'lowerLimit': '-1.03', 'upperLimit': '2.08'}, {'value': '-0.6', 'groupId': 'OG009', 'lowerLimit': '-1.69', 'upperLimit': '0.56'}, {'value': '-1.2', 'groupId': 'OG010', 'lowerLimit': '-2.30', 'upperLimit': '-0.04'}, {'value': '-2.0', 'groupId': 'OG011', 'lowerLimit': '-4.33', 'upperLimit': '0.34'}, {'value': '0.6', 'groupId': 'OG012', 'lowerLimit': '-1.89', 'upperLimit': '3.06'}]}]}], 'analyses': [{'pValue': '0.156', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-6.64', 'ciUpperLimit': '1.07', 'groupDescription': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.127', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-7.11', 'ciUpperLimit': '0.89', 'groupDescription': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.002', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.5', 'ciLowerLimit': '-10.52', 'ciUpperLimit': '-2.42', 'groupDescription': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.089', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-5.86', 'ciUpperLimit': '0.42', 'groupDescription': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.245', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-6.12', 'ciUpperLimit': '1.57', 'groupDescription': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.678', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-4.65', 'ciUpperLimit': '3.02', 'groupDescription': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.040', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.1', 'ciLowerLimit': '-8.07', 'ciUpperLimit': '-0.19', 'groupDescription': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.038', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-6.61', 'ciUpperLimit': '-0.19', 'groupDescription': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.601', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-3.38', 'ciUpperLimit': '1.96', 'groupDescription': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.760', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-3.20', 'ciUpperLimit': '2.34', 'groupDescription': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.051', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-5.60', 'ciUpperLimit': '0.01', 'groupDescription': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.105', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-3.98', 'ciUpperLimit': '0.38', 'groupDescription': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.820', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-2.36', 'ciUpperLimit': '2.98', 'groupDescription': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.157', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.9', 'ciLowerLimit': '-4.58', 'ciUpperLimit': '0.74', 'groupDescription': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.859', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-2.99', 'ciUpperLimit': '2.49', 'groupDescription': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.054', 'groupIds': ['OG007', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-4.41', 'ciUpperLimit': '0.04', 'groupDescription': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)', 'description': 'At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-hour Urinary Glucose Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '163', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'OG009', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG010', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG011', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG012', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '208.6', 'groupId': 'OG000', 'lowerLimit': '101.85', 'upperLimit': '315.40'}, {'value': '134.6', 'groupId': 'OG001', 'lowerLimit': '-8.69', 'upperLimit': '277.85'}, {'value': '377.0', 'groupId': 'OG002', 'lowerLimit': '206.19', 'upperLimit': '547.90'}, {'value': '306.1', 'groupId': 'OG003', 'lowerLimit': '199.59', 'upperLimit': '412.62'}, {'value': '183.0', 'groupId': 'OG004', 'lowerLimit': '32.37', 'upperLimit': '333.70'}, {'value': '193.8', 'groupId': 'OG005', 'lowerLimit': '82.22', 'upperLimit': '305.31'}, {'value': '241.3', 'groupId': 'OG006', 'lowerLimit': '135.13', 'upperLimit': '347.30'}, {'value': '308.9', 'groupId': 'OG007', 'lowerLimit': '198.27', 'upperLimit': '419.53'}, {'value': '-17.8', 'groupId': 'OG008', 'lowerLimit': '-94.20', 'upperLimit': '58.61'}, {'value': '26.8', 'groupId': 'OG009', 'lowerLimit': '-30.03', 'upperLimit': '83.70'}, {'value': '122.5', 'groupId': 'OG010', 'lowerLimit': '69.82', 'upperLimit': '175.26'}, {'value': '248.0', 'groupId': 'OG011', 'lowerLimit': '137.72', 'upperLimit': '358.33'}, {'value': '-148.9', 'groupId': 'OG012', 'lowerLimit': '-269.62', 'upperLimit': '-28.10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)', 'description': 'Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.', 'unitOfMeasure': 'mmol/24hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG001', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG002', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG003', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-0.70', 'upperLimit': '0.33'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.68', 'upperLimit': '0.35'}, {'value': '-2.4', 'groupId': 'OG002', 'lowerLimit': '-3.47', 'upperLimit': '-1.33'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '-0.74', 'upperLimit': '1.55'}]}]}], 'analyses': [{'pValue': '0.355', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.84', 'ciUpperLimit': '0.66', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.373', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.83', 'ciUpperLimit': '0.69', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-4.36', 'ciUpperLimit': '-1.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}], 'paramType': 'MEAN', 'timeFrame': 'Between Week 24 and Week 48 (Epoch 4)', 'description': 'Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)', 'unitOfMeasure': 'Percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '49.6', 'spread': '25.08', 'groupId': 'OG000'}, {'value': '33.1', 'spread': '29.65', 'groupId': 'OG001'}, {'value': '40.2', 'spread': '21.55', 'groupId': 'OG002'}, {'value': '34.6', 'spread': '17.56', 'groupId': 'OG003'}, {'value': '44.7', 'spread': '26.83', 'groupId': 'OG004'}, {'value': '43.6', 'spread': '16.91', 'groupId': 'OG005'}, {'value': '38.0', 'spread': '22.13', 'groupId': 'OG006'}, {'value': '47.9', 'spread': '23.64', 'groupId': 'OG007'}, {'value': '43.0', 'spread': '22.63', 'groupId': 'OG008'}]}]}, {'title': 'Week 24 (Timepoint 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '48.8', 'spread': '26.59', 'groupId': 'OG000'}, {'value': '38.1', 'spread': '32.20', 'groupId': 'OG001'}, {'value': '39.8', 'spread': '22.48', 'groupId': 'OG002'}, {'value': '40.1', 'spread': '18.20', 'groupId': 'OG003'}, {'value': '52.4', 'spread': '32.78', 'groupId': 'OG004'}, {'value': '45.9', 'spread': '15.41', 'groupId': 'OG005'}, {'value': '38.0', 'spread': '22.13', 'groupId': 'OG006'}, {'value': '48.1', 'spread': '21.93', 'groupId': 'OG007'}, {'value': '44.7', 'spread': '23.0', 'groupId': 'OG008'}]}]}, {'title': 'Week 24 (Timepoint 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '54.2', 'spread': '29.34', 'groupId': 'OG000'}, {'value': '42.0', 'spread': '29.99', 'groupId': 'OG001'}, {'value': '39.2', 'spread': '20.24', 'groupId': 'OG002'}, {'value': '62.8', 'spread': '34.26', 'groupId': 'OG003'}, {'value': '51.2', 'spread': '35.32', 'groupId': 'OG004'}, {'value': '54.6', 'spread': '23.77', 'groupId': 'OG005'}, {'value': '37.9', 'spread': '32.33', 'groupId': 'OG006'}, {'value': '53.0', 'spread': '26.95', 'groupId': 'OG007'}, {'value': '52.2', 'spread': '30.75', 'groupId': 'OG008'}]}]}, {'title': 'Week 24 (Timepoint 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '22.74', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '19.56', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '12.07', 'groupId': 'OG002'}, {'value': '22.8', 'spread': '28.42', 'groupId': 'OG003'}, {'value': '-1.2', 'spread': '7.77', 'groupId': 'OG004'}, {'value': '8.7', 'spread': '18.21', 'groupId': 'OG005'}, {'value': '-0.1', 'spread': '14.39', 'groupId': 'OG006'}, {'value': '4.9', 'spread': '26.20', 'groupId': 'OG007'}, {'value': '7.5', 'spread': '32.91', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.', 'unitOfMeasure': 'mmol/24hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG001', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG002', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG003', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.84', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '4.07', 'groupId': 'OG003'}]}]}, {'title': 'Week 48(Timepoint 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '307', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.95', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '6.6', 'spread': '4.55', 'groupId': 'OG003'}]}]}, {'title': 'Week 48(Timepoint 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '4.55', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '3.65', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '2.10', 'groupId': 'OG003'}]}]}, {'title': 'Week 48(Timepoint 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.81', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '4.10', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '3.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': 'Evaluation of 24-hour urinary calcium after 48 weeks of treatment', 'unitOfMeasure': 'mmol/24hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '26', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '282.1', 'spread': '128.10', 'groupId': 'OG000'}, {'value': '240.5', 'spread': '74.64', 'groupId': 'OG001'}, {'value': '254.5', 'spread': '105.70', 'groupId': 'OG002'}, {'value': '291.5', 'spread': '175.10', 'groupId': 'OG003'}, {'value': '284.0', 'spread': '117.60', 'groupId': 'OG004'}, {'value': '241.8', 'spread': '82.75', 'groupId': 'OG005'}, {'value': '277.0', 'spread': '99.67', 'groupId': 'OG006'}, {'value': '293.7', 'spread': '120.70', 'groupId': 'OG007'}, {'value': '297.0', 'spread': '145.10', 'groupId': 'OG008'}]}]}, {'title': 'Week 24 (Timepoint 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '284.0', 'spread': '140.10', 'groupId': 'OG000'}, {'value': '239.7', 'spread': '80.40', 'groupId': 'OG001'}, {'value': '260.9', 'spread': '111.10', 'groupId': 'OG002'}, {'value': '275.0', 'spread': '101.30', 'groupId': 'OG003'}, {'value': '319.9', 'spread': '32.78', 'groupId': 'OG004'}, {'value': '246.5', 'spread': '84.19', 'groupId': 'OG005'}, {'value': '299.3', 'spread': '79.06', 'groupId': 'OG006'}, {'value': '302.5', 'spread': '121.30', 'groupId': 'OG007'}, {'value': '307.9', 'spread': '145.90', 'groupId': 'OG008'}]}]}, {'title': 'Week 24 (Timepoint 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '297.7', 'spread': '117.40', 'groupId': 'OG000'}, {'value': '295.3', 'spread': '95.60', 'groupId': 'OG001'}, {'value': '299.2', 'spread': '145.50', 'groupId': 'OG002'}, {'value': '264.7', 'spread': '74.84', 'groupId': 'OG003'}, {'value': '317.8', 'spread': '205.10', 'groupId': 'OG004'}, {'value': '341.6', 'spread': '109.20', 'groupId': 'OG005'}, {'value': '260.5', 'spread': '124.80', 'groupId': 'OG006'}, {'value': '289.3', 'spread': '83.62', 'groupId': 'OG007'}, {'value': '352.8', 'spread': '159.30', 'groupId': 'OG008'}]}]}, {'title': 'Week 24 (Timepoint 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '13', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}, {'value': '24', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '13.0', 'spread': '132.00', 'groupId': 'OG000'}, {'value': '55.6', 'spread': '89.81', 'groupId': 'OG001'}, {'value': '38.3', 'spread': '70.00', 'groupId': 'OG002'}, {'value': '-10.2', 'spread': '103.60', 'groupId': 'OG003'}, {'value': '-2.1', 'spread': '159.60', 'groupId': 'OG004'}, {'value': '95.1', 'spread': '67.36', 'groupId': 'OG005'}, {'value': '-38.7', 'spread': '107.80', 'groupId': 'OG006'}, {'value': '-13.2', 'spread': '153.80', 'groupId': 'OG007'}, {'value': '44.9', 'spread': '177.60', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24, Week 48', 'description': 'Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment', 'unitOfMeasure': 'mmol/24hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG001', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG002', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG003', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.6', 'spread': '11.46', 'groupId': 'OG000'}, {'value': '30.5', 'spread': '11.63', 'groupId': 'OG001'}, {'value': '28.6', 'spread': '14.11', 'groupId': 'OG002'}, {'value': '40.2', 'spread': '15.96', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 (Timepoint 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.5', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '30.2', 'spread': '11.85', 'groupId': 'OG001'}, {'value': '28.6', 'spread': '14.11', 'groupId': 'OG002'}, {'value': '44.4', 'spread': '17.60', 'groupId': 'OG003'}]}]}, {'title': 'Week 48 (Timepoint 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.7', 'spread': '12.74', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '16.21', 'groupId': 'OG001'}, {'value': '31.0', 'spread': '14.67', 'groupId': 'OG002'}, {'value': '29.0', 'spread': '15.42', 'groupId': 'OG003'}]}]}, {'title': 'Week 48(Timepoint 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '11.44', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '14.52', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '17.33', 'groupId': 'OG002'}, {'value': '-15.5', 'spread': '18.92', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24, Week 48', 'description': 'Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment', 'unitOfMeasure': 'mmol/24hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Lipid Profile (Lipoproteins)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '163', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'OG009', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG010', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG011', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG012', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'title': 'Apoliprotein A1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '151', 'groupId': 'OG009'}, {'value': '152', 'groupId': 'OG010'}, {'value': '36', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000', 'lowerLimit': '4.26', 'upperLimit': '13.61'}, {'value': '8.13', 'groupId': 'OG001', 'lowerLimit': '3.27', 'upperLimit': '13.30'}, {'value': '10.7', 'groupId': 'OG002', 'lowerLimit': '5.38', 'upperLimit': '15.97'}, {'value': '8.9', 'groupId': 'OG003', 'lowerLimit': '5.55', 'upperLimit': '12.21'}, {'value': '5.3', 'groupId': 'OG004', 'lowerLimit': '0.487', 'upperLimit': '10.17'}, {'value': '8.1', 'groupId': 'OG005', 'lowerLimit': '3.44', 'upperLimit': '12.86'}, {'value': '6.7', 'groupId': 'OG006', 'lowerLimit': '1.75', 'upperLimit': '11.59'}, {'value': '11.0', 'groupId': 'OG007', 'lowerLimit': '7.47', 'upperLimit': '14.44'}, {'value': '6.7', 'groupId': 'OG008', 'lowerLimit': '3.41', 'upperLimit': '10.06'}, {'value': '3.0', 'groupId': 'OG009', 'lowerLimit': '0.92', 'upperLimit': '5.10'}, {'value': '3.4', 'groupId': 'OG010', 'lowerLimit': '1.22', 'upperLimit': '5.51'}, {'value': '5.6', 'groupId': 'OG011', 'lowerLimit': '1.35', 'upperLimit': '9.89'}, {'value': '-0.7', 'groupId': 'OG012', 'lowerLimit': '-5.27', 'upperLimit': '3.87'}]}]}, {'title': 'Apoliprotein B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '151', 'groupId': 'OG009'}, {'value': '152', 'groupId': 'OG010'}, {'value': '36', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '-5.32', 'upperLimit': '11.08'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '-1.23', 'upperLimit': '16.61'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '-6.06', 'upperLimit': '12.72'}, {'value': '12.4', 'groupId': 'OG003', 'lowerLimit': '6.57', 'upperLimit': '18.32'}, {'value': '-0.4', 'groupId': 'OG004', 'lowerLimit': '-8.91', 'upperLimit': '8.18'}, {'value': '4.5', 'groupId': 'OG005', 'lowerLimit': '-3.84', 'upperLimit': '12.74'}, {'value': '2.3', 'groupId': 'OG006', 'lowerLimit': '-6.36', 'upperLimit': '10.98'}, {'value': '3.9', 'groupId': 'OG007', 'lowerLimit': '-2.29', 'upperLimit': '10.01'}, {'value': '5.8', 'groupId': 'OG008', 'lowerLimit': '-0.03', 'upperLimit': '11.69'}, {'value': '-1.7', 'groupId': 'OG009', 'lowerLimit': '-4.39', 'upperLimit': '1.08'}, {'value': '-2.4', 'groupId': 'OG010', 'lowerLimit': '-5.23', 'upperLimit': '0.38'}, {'value': '-2.3', 'groupId': 'OG011', 'lowerLimit': '-7.85', 'upperLimit': '3.31'}, {'value': '-2.0', 'groupId': 'OG012', 'lowerLimit': '-8.00', 'upperLimit': '3.96'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, Week 24 to Week 48 (Epoch 4)', 'description': 'Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48', 'unitOfMeasure': 'g/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Sensitive C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '163', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'OG009', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG010', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG011', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG012', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.78', 'upperLimit': '1.25'}, {'value': '1.06', 'groupId': 'OG001', 'lowerLimit': '0.83', 'upperLimit': '1.36'}, {'value': '1.31', 'groupId': 'OG002', 'lowerLimit': '1.01', 'upperLimit': '1.69'}, {'value': '0.98', 'groupId': 'OG003', 'lowerLimit': '0.83', 'upperLimit': '1.16'}, {'value': '1.02', 'groupId': 'OG004', 'lowerLimit': '0.80', 'upperLimit': '1.30'}, {'value': '0.93', 'groupId': 'OG005', 'lowerLimit': '0.74', 'upperLimit': '118'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '0.78', 'upperLimit': '1.27'}, {'value': '0.98', 'groupId': 'OG007', 'lowerLimit': '0.83', 'upperLimit': '1.17'}, {'value': '0.92', 'groupId': 'OG008', 'lowerLimit': '0.78', 'upperLimit': '1.09'}, {'value': '0.95', 'groupId': 'OG009', 'lowerLimit': '0.85', 'upperLimit': '1.06'}, {'value': '0.93', 'groupId': 'OG010', 'lowerLimit': '0.83', 'upperLimit': '1.04'}, {'value': '0.96', 'groupId': 'OG011', 'lowerLimit': '0.77', 'upperLimit': '1.20'}, {'value': '1.07', 'groupId': 'OG012', 'lowerLimit': '0.84', 'upperLimit': '1.36'}]}]}], 'analyses': [{'pValue': '0.632', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.352', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.55', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.027', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.41', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.92', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.587', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.35', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.508', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.47', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.945', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.34', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.602', 'groupIds': ['OG006', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.45', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.612', 'groupIds': ['OG007'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.35', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.382', 'groupIds': ['OG009', 'OG012'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.310', 'groupIds': ['OG010', 'OG012'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.14', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.525', 'groupIds': ['OG011', 'OG012'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Week 24, Week 24 to Week 48 (Epoch 4)', 'description': 'Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48', 'unitOfMeasure': 'mg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '158', 'groupId': 'OG009'}, {'value': '163', 'groupId': 'OG010'}, {'value': '39', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'OG009', 'title': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG010', 'title': 'LIK066 Bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG011', 'title': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}, {'id': 'OG012', 'title': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily'}], 'classes': [{'title': 'Triglycerides (TG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '150', 'groupId': 'OG009'}, {'value': '149', 'groupId': 'OG010'}, {'value': '36', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'groupId': 'OG000', 'lowerLimit': '-14.91', 'upperLimit': '7.26'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '-11.19', 'upperLimit': '13.80'}, {'value': '-11.5', 'groupId': 'OG002', 'lowerLimit': '-24.03', 'upperLimit': '.093'}, {'value': '-3.0', 'groupId': 'OG003', 'lowerLimit': '-10.94', 'upperLimit': '4.91'}, {'value': '2.3', 'groupId': 'OG004', 'lowerLimit': '-8.94', 'upperLimit': '13.57'}, {'value': '1.7', 'groupId': 'OG005', 'lowerLimit': '-9.30', 'upperLimit': '12.77'}, {'value': '5.5', 'groupId': 'OG006', 'lowerLimit': '-5.94', 'upperLimit': '16.89'}, {'value': '-7.4', 'groupId': 'OG007', 'lowerLimit': '-15.60', 'upperLimit': '0.87'}, {'value': '4.0', 'groupId': 'OG008', 'lowerLimit': '-3.82', 'upperLimit': '11.87'}, {'value': '6.7', 'groupId': 'OG009', 'lowerLimit': '0.18', 'upperLimit': '13.13'}, {'value': '12.4', 'groupId': 'OG010', 'lowerLimit': '5.75', 'upperLimit': '19.13'}, {'value': '-0.9', 'groupId': 'OG011', 'lowerLimit': '-14.48', 'upperLimit': '12.59'}, {'value': '4.8', 'groupId': 'OG012', 'lowerLimit': '-9.57', 'upperLimit': '19.16'}]}]}, {'title': 'Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '151', 'groupId': 'OG009'}, {'value': '152', 'groupId': 'OG010'}, {'value': '36', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '-0.92', 'upperLimit': '12.99'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '-0.23', 'upperLimit': '14.92'}, {'value': '4.8', 'groupId': 'OG002', 'lowerLimit': '-3.15', 'upperLimit': '12.78'}, {'value': '14.6', 'groupId': 'OG003', 'lowerLimit': '9.61', 'upperLimit': '19.58'}, {'value': '1.5', 'groupId': 'OG004', 'lowerLimit': '-5.79', 'upperLimit': '8.71'}, {'value': '5.1', 'groupId': 'OG005', 'lowerLimit': '-1.89', 'upperLimit': '12.19'}, {'value': '6.4', 'groupId': 'OG006', 'lowerLimit': '-0.94', 'upperLimit': '13.75'}, {'value': '8.8', 'groupId': 'OG007', 'lowerLimit': '-0.23', 'upperLimit': '9.70'}, {'value': '4.7', 'groupId': 'OG008', 'lowerLimit': '-0.23', 'upperLimit': '9.70'}, {'value': '0.8', 'groupId': 'OG009', 'lowerLimit': '-1.65', 'upperLimit': '3.27'}, {'value': '0.3', 'groupId': 'OG010', 'lowerLimit': '-2.22', 'upperLimit': '2.81'}, {'value': '0.8', 'groupId': 'OG011', 'lowerLimit': '-4.22', 'upperLimit': '5.81'}, {'value': '-1.7', 'groupId': 'OG012', 'lowerLimit': '-7.04', 'upperLimit': '3.68'}]}]}, {'title': 'HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '151', 'groupId': 'OG009'}, {'value': '152', 'groupId': 'OG010'}, {'value': '36', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '-5.25', 'upperLimit': '6.76'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '-1.52', 'upperLimit': '11.28'}, {'value': '5.2', 'groupId': 'OG002', 'lowerLimit': '-1.55', 'upperLimit': '12.01'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '3.71', 'upperLimit': '12.25'}, {'value': '2.9', 'groupId': 'OG004', 'lowerLimit': '-3.29', 'upperLimit': '9.16'}, {'value': '2.4', 'groupId': 'OG005', 'lowerLimit': '-3.60', 'upperLimit': '8.48'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '-4.86', 'upperLimit': '7.81'}, {'value': '8.0', 'groupId': 'OG007', 'lowerLimit': '3.56', 'upperLimit': '12.47'}, {'value': '0.7', 'groupId': 'OG008', 'lowerLimit': '-3.54', 'upperLimit': '5.00'}, {'value': '3.9', 'groupId': 'OG009', 'lowerLimit': '0.84', 'upperLimit': '7.03'}, {'value': '3.7', 'groupId': 'OG010', 'lowerLimit': '0.54', 'upperLimit': '6.90'}, {'value': '9.2', 'groupId': 'OG011', 'lowerLimit': '2.88', 'upperLimit': '15.57'}, {'value': '0.7', 'groupId': 'OG012', 'lowerLimit': '-6.11', 'upperLimit': '7.48'}]}]}, {'title': 'LDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}, {'value': '78', 'groupId': 'OG008'}, {'value': '151', 'groupId': 'OG009'}, {'value': '152', 'groupId': 'OG010'}, {'value': '36', 'groupId': 'OG011'}, {'value': '34', 'groupId': 'OG012'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '-2.14', 'upperLimit': '19.61'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '5.73', 'upperLimit': '29.20'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '-4.21', 'upperLimit': '20.25'}, {'value': '21.8', 'groupId': 'OG003', 'lowerLimit': '14.08', 'upperLimit': '29.55'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '-7.22', 'upperLimit': '15.38'}, {'value': '8.7', 'groupId': 'OG005', 'lowerLimit': '-2.26', 'upperLimit': '19.68'}, {'value': '7.7', 'groupId': 'OG006', 'lowerLimit': '-3.77', 'upperLimit': '19.13'}, {'value': '10.9', 'groupId': 'OG007', 'lowerLimit': '2.80', 'upperLimit': '19.04'}, {'value': '12.5', 'groupId': 'OG008', 'lowerLimit': '4.70', 'upperLimit': '20.30'}, {'value': '-0.6', 'groupId': 'OG009', 'lowerLimit': '-4.14', 'upperLimit': '2.96'}, {'value': '-1.2', 'groupId': 'OG010', 'lowerLimit': '-4.79', 'upperLimit': '2.49'}, {'value': '-1.4', 'groupId': 'OG011', 'lowerLimit': '-8.66', 'upperLimit': '5.83'}, {'value': '-3.5', 'groupId': 'OG012', 'lowerLimit': '-11.28', 'upperLimit': '4.24'}]}]}], 'analyses': [{'pValue': '0.254', 'groupIds': ['OG000', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.9', 'ciLowerLimit': '-21.37', 'ciUpperLimit': '5.65', 'groupDescription': 'Triglycerides (TG)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.716', 'groupIds': ['OG001', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-17.44', 'ciUpperLimit': '11.99', 'groupDescription': 'Triglycerides (TG)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.038', 'groupIds': ['OG002', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.6', 'ciLowerLimit': '-30.30', 'ciUpperLimit': '-0.86', 'groupDescription': 'Triglycerides (TG)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.213', 'groupIds': ['OG003', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.0', 'ciLowerLimit': '-18.15', 'ciUpperLimit': '4.06', 'groupDescription': 'Triglycerides (TG)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.806', 'groupIds': ['OG004', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-15.38', 'ciUpperLimit': '11.96', 'groupDescription': 'Triglycerides (TG)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.739', 'groupIds': ['OG005', 'OG008'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-15.80', 'ciUpperLimit': '11.21', 'groupDescription': 'Triglycerides (TG)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Dose finding study'}, {'pValue': '0.837', 'groupIds': ['OG006', 'OG008'], 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'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '196', 'spread': '186', 'groupId': 'OG000'}, {'value': '275', 'spread': '000', 'groupId': 'OG001'}, {'value': '2280', 'spread': '522', 'groupId': 'OG002'}, {'value': '5700', 'spread': '1490', 'groupId': 'OG003'}, {'value': '105', 'spread': '17.1', 'groupId': 'OG004'}, {'value': '273', 'spread': '69.3', 'groupId': 'OG005'}, {'value': '1520', 'spread': '277', 'groupId': 'OG006'}, {'value': '2190', 'spread': '841', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Summary at Week 24 from qd or bid regimens (0-6h)', 'description': "Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)", 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Population'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}, {'value': '38', 'groupId': 'OG004'}, {'value': '39', 'groupId': 'OG005'}, {'value': '37', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'OG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'OG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '196', 'spread': '186', 'groupId': 'OG000'}, {'value': '275', 'spread': '000', 'groupId': 'OG001'}, {'value': '2290', 'spread': '526', 'groupId': 'OG002'}, {'value': '5690', 'spread': '1480', 'groupId': 'OG003'}, {'value': '105', 'spread': '17.2', 'groupId': 'OG004'}, {'value': '273', 'spread': '70.2', 'groupId': 'OG005'}, {'value': '1520', 'spread': '271', 'groupId': 'OG006'}, {'value': '2190', 'spread': '843', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Summary at Week 24 from qd or bid regimens', 'description': 'Last non-zero concentration area under the curve (AUClast)', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'FG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'FG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'FG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'FG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'FG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'FG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'FG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'FG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'FG009', 'title': 'LIK066 qd/LIK066 25 mg qd (Epoch 4)', 'description': 'LIK066 qd (once daily) patients who entered Epoch 4 and received LIK066 25 mg qd'}, {'id': 'FG010', 'title': 'LIK066 Bid/LIK066 35 mg qd (Epoch 4)', 'description': 'LIK066 bid patients who entered Epoch 4 and received LIK066 35 mg qd'}, {'id': 'FG011', 'title': 'Placebo/LIK066 25 mg qd (Epoch 4)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'FG012', 'title': 'Placebo qd (Epoch 4)', 'description': 'Placebo patients who entered Epoch 4 and received matching Placebo tablets qd'}], 'periods': [{'title': 'Epoch 3 (24 Weeks of Treatment)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '77'}, {'groupId': 'FG004', 'numSubjects': '38'}, {'groupId': 'FG005', 'numSubjects': '39'}, {'groupId': 'FG006', 'numSubjects': '38'}, {'groupId': 'FG007', 'numSubjects': '76'}, {'groupId': 'FG008', 'numSubjects': '78'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '36'}, {'groupId': 'FG005', 'numSubjects': '37'}, {'groupId': 'FG006', 'numSubjects': '30'}, {'groupId': 'FG007', 'numSubjects': '60'}, {'groupId': 'FG008', 'numSubjects': '73'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '16'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}, {'title': 'Epoch 4 (Last 24 Weeks of the Study)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '158'}, {'groupId': 'FG010', 'numSubjects': '163'}, {'groupId': 'FG011', 'numSubjects': '39'}, {'groupId': 'FG012', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '153'}, {'groupId': 'FG010', 'numSubjects': '148'}, {'groupId': 'FG011', 'numSubjects': '36'}, {'groupId': 'FG012', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '15'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}]}, {'type': 'non-compliance with study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.', 'preAssignmentDetails': 'Overall, 674 patients were screened. Of the 460 patients who were randomized to the study, the majority (85.7%) completed Epoch 3. Of the 394 patients who completed Epoch 3 and entered Epoch 4, the majority (93.1%) completed the Epoch 4 study period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}, {'value': '39', 'groupId': 'BG005'}, {'value': '38', 'groupId': 'BG006'}, {'value': '76', 'groupId': 'BG007'}, {'value': '78', 'groupId': 'BG008'}, {'value': '460', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'BG001', 'title': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'BG002', 'title': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'BG003', 'title': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks'}, {'id': 'BG004', 'title': 'LIK066 2.5mg Bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'BG005', 'title': 'LIK066 5mg Bid (Epoch 3)', 'description': 'LIK066 5mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'BG006', 'title': 'LIK066 25mg Bid (Epoch 3)', 'description': 'LIK066 25mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'BG007', 'title': 'LIK066 50mg Bid (Epoch 3)', 'description': 'LIK066 50mg bid (twice daily) dosing frequency for 24 weeks'}, {'id': 'BG008', 'title': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '12.20', 'groupId': 'BG000'}, {'value': '53.2', 'spread': '10.08', 'groupId': 'BG001'}, {'value': '52.9', 'spread': '13.60', 'groupId': 'BG002'}, {'value': '51.1', 'spread': '12.94', 'groupId': 'BG003'}, {'value': '53.4', 'spread': '12.28', 'groupId': 'BG004'}, {'value': '49.8', 'spread': '11.50', 'groupId': 'BG005'}, {'value': '49.7', 'spread': '11.93', 'groupId': 'BG006'}, {'value': '52.9', 'spread': '11.87', 'groupId': 'BG007'}, {'value': '51.1', 'spread': '13.27', 'groupId': 'BG008'}, {'value': '51.7', 'spread': '12.31', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '49', 'groupId': 'BG007'}, {'value': '45', 'groupId': 'BG008'}, {'value': '283', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '27', 'groupId': 'BG007'}, {'value': '33', 'groupId': 'BG008'}, {'value': '177', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '10', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}, {'value': '42', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}, {'value': '63', 'groupId': 'BG007'}, {'value': '64', 'groupId': 'BG008'}, {'value': '392', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-19', 'size': 738387, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-07-30T14:25', 'hasProtocol': True}, {'date': '2018-08-15', 'size': 540963, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-07-30T14:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'dispFirstSubmitDate': '2019-01-16', 'completionDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2017-03-03', 'dispFirstSubmitQcDate': '2019-01-16', 'resultsFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2017-03-28', 'dispFirstPostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-27', 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Body Weight at 24 Weeks', 'timeFrame': 'Baseline, Week 24 (Epoch 3)', 'description': 'Dose-response relationship of two dose regimens of LIK066 as measured by the percent change from baseline in body weight relative to placebo after 24 weeks of treatment'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Overall Study', 'timeFrame': 'Baseline, Week 24', 'description': 'Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline'}, {'measure': 'Number of Subjects With Response Rate According to Percent Decrease in Body Weight for Subgroups', 'timeFrame': 'Baseline, Week 24', 'description': 'Responder rates according to percentage decrease in body weight either ≥ 5 % or ≥ 10 % from baseline for dysglycemic, normoglycemic, Type 2 Diabetes Mellitus (T2DM)'}, {'measure': 'Percentage Change From Baseline on Waist Circumference', 'timeFrame': 'Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)', 'description': 'Waist circumference will be measured to the nearest 0.1cm in a standing position, at the end of a normal expiration, using a tape at the level of the iliac crest.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose (FPG) in Type 2 Diabetes Mellitus Patients (T2DM)', 'timeFrame': 'Baseline, Week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)', 'description': 'FPG will be measured from a blood sample obtained after an overnight fast (at least 8h after last evening food intake).'}, {'measure': 'Change From Baseline in Glycated Hemoglobin A1c (HbA1c) in Type 2 Diabetes Mellitus Patients (T2DM)', 'timeFrame': 'Baseline, Week 24 (Epoch 3), Week 24 to week 48 (Epoch 4)', 'description': 'HbA1c will be measured from a blood sample obtained at indicated visits and will be analyzed at a central laboratory.'}, {'measure': 'Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)', 'timeFrame': 'Baseline, Week 24 (Epoch 3) Week 24 to Week 48 (Epoch 4)', 'description': 'At each study visit (baseline, week 24, Week 48), after the subject has been sitting for 5 minutes with the back supported and both feet placed on the floor, SBP and DBP will be measured'}, {'measure': 'Change From Baseline in 24-hour Urinary Glucose Excretion', 'timeFrame': 'Baseline, week 24 (Epoch 3), Week 24 to Week 48 (Epoch 4)', 'description': 'Urinary glucose excretion will be measured from 24-hour urinary collection at indicated visits and will be analyzed at a central laboratory.'}, {'measure': 'Percentage Change in Weight in the Overall Population and by Subgroups (Epoch 4)', 'timeFrame': 'Between Week 24 and Week 48 (Epoch 4)', 'description': 'Between -treatment analysis of percentage change from Week 24 in body weight (kg) at Week 48 (Epoch 4)'}, {'measure': 'Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Calcium Excretion', 'timeFrame': 'Baseline, Week 24', 'description': 'Evaluation of 24-hour urinary calcium excretion after 24 week of treatment.'}, {'measure': 'Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Calcium Excretion', 'timeFrame': 'Baseline, Week 24, Week 48', 'description': 'Evaluation of 24-hour urinary calcium after 48 weeks of treatment'}, {'measure': 'Change From Baseline to Week 24 (Epoch 3) in the 24-hour Urinary Phosphorus Excretion', 'timeFrame': 'Week 24, Week 48', 'description': 'Evaluation of 24-hour urinary phosphorus excretion after 24 weeks of treatment'}, {'measure': 'Change From Baseline Week 24 to Week 48 (Epoch 4) in the 24-hour Urinary Phosphorus Excretion', 'timeFrame': 'Week 24, Week 48', 'description': 'Evaluation of 24-hour urinary phosphorus excretion after 48 weeks of treatment'}, {'measure': 'Change From Baseline in Fasting Lipid Profile (Lipoproteins)', 'timeFrame': 'Baseline, Week 24, Week 24 to Week 48 (Epoch 4)', 'description': 'Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48'}, {'measure': 'Change From Baseline in High Sensitive C-reactive Protein (hsCRP)', 'timeFrame': 'Baseline to Week 24, Week 24 to Week 48 (Epoch 4)', 'description': 'Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48'}, {'measure': 'Change From Baseline in Fasting Lipid Profile (Triglycerides/Cholesterol)', 'timeFrame': 'Baseline to Week 24, Week 24 to Week 48 (Epoch 4)', 'description': 'Between-treatment analysis of change after 24 weeks of treatment and between Week 24 and Week 48'}, {'measure': 'Pharmacokinetics of LIK066: Observe Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Summary at Week 24 from qd or bid regimens', 'description': 'Observe maximum plasma concentration following administration of LIK066 (Cmax)'}, {'measure': 'Pharmacokinetics of LIK066: Time to Reach the Maximum Concentration (Tmax)', 'timeFrame': 'Summary at Week 24 for qd or bid regimens', 'description': 'Time to reach the maximum concentration after administration of LIK066 (Tmax)'}, {'measure': "Pharmacokinetics of LIK066: Area Under the Plasma Concentration-time Curve From Time Zero Time 't' (AUC0-t)", 'timeFrame': 'Summary at Week 24 from qd or bid regimens (0-6h)', 'description': "Area under the plasma concentration-time curve from time zero time 't' where t is a defined time point after administration (AUC0-t)"}, {'measure': 'Pharmacokinetics of LIK066: Last Non-zero Concentration Area Under the Curve (AUClast)', 'timeFrame': 'Summary at Week 24 from qd or bid regimens', 'description': 'Last non-zero concentration area under the curve (AUClast)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'Overweight'], 'conditions': ['Obesity', 'Overweight']}, 'descriptionModule': {'briefSummary': 'This was a dose-finding study that evaluated the change in weight after 24 weeks treatment with 8 different doses of LIK066 compared to placebo in obese or overweight adults, followed by 24 weeks treatment with 2 doses of LIK066 and placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. informed consent\n2. (BMI\\>=30) or (BMI\\>=27 with history of CV disease, hypertension, dyslipidemia, pre-diabetes or type 2 diabetes mellitus, sleep-apnea syndrome)\n3. willing to comply with life-style intervention and treatment during the full duration of the study (approximately 54 weeks)\n\nExclusion Criteria:\n\n* Hypersensitivity to any of the study medications\n* Pregnancy or lactating women\n* History of malignancies\n* Use of pharmacologically active weight loss products\n* Bariatric surgery\n* Ketoacidosis, lactic acidosis, hyperosmolar coma in the 6 months before the screening visit.\n* HbA1c \\>10% at the screening visit.'}, 'identificationModule': {'nctId': 'NCT03100058', 'briefTitle': 'A Study to Evaluate the Change in Weight After 24 Weeks Treatment With LIK066 in Obese or Overweight Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Dose-finding Study to Evaluate the Change in Weight After 24 Weeks Treatment With 8 Doses of LIK066 Compared to Placebo in Obese or Overweight Adults, Followed by 24 Weeks Treatment With 2 Doses of LIK066 and Placebo', 'orgStudyIdInfo': {'id': 'CLIK066B2201'}, 'secondaryIdInfos': [{'id': '2016-002868-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LIK066 2.5mg qd (Epoch 3)', 'description': 'LIK066 2.5mg qd (once daily) dosing frequency for 24 weeks.', 'interventionNames': ['Drug: LIK066']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Epoch 3)', 'description': 'Matching placebo tablets for 24 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 10mg qd (Epoch 3)', 'description': 'LIK066 10mg qd (once daily) dosing frequency for 24 weeks', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 50mg qd (Epoch 3)', 'description': 'LIK066 50mg qd (once daily) dosing frequency for 24 weeks', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 150mg qd (Epoch 3)', 'description': 'LIK066 150mg qd (once daily) dosing frequency for 24 weeks', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 2.5mg bid (Epoch 3)', 'description': 'LIK066 2.5mg bid (once daily) dosing frequency for 24 weeks', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 5mg bid (Epoch 3)', 'description': 'LIK066 5mg bid (once daily) dosing frequency for 24 weeks', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 25mg bid (Epoch 3)', 'description': 'LIK066 25mg bid (once daily) dosing frequency for 24 weeks', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 50mg bid (Epoch 3)', 'description': 'LIK066 50mg bid dosing frequency for 24 weeks', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'LIK066 bid/LIK066 35mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily', 'interventionNames': ['Drug: LIK066']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo/LIK066 25mg qd (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily', 'interventionNames': ['Drug: LIK066']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Placebo (Epoch 4)', 'description': 'Between week 24 to week 48, the patients who received a once daily regimen in the first 24 weeks will receive Dose A of LIK066 once daily and patients who received a twice daily regimen in the first 24 weeks will receive Dose B LIK066 once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LIK066', 'type': 'DRUG', 'description': 'LIK066 will be supplied in different doses as tablets to be taken orally.', 'armGroupLabels': ['LIK066 10mg qd (Epoch 3)', 'LIK066 150mg qd (Epoch 3)', 'LIK066 2.5mg bid (Epoch 3)', 'LIK066 2.5mg qd (Epoch 3)', 'LIK066 25mg bid (Epoch 3)', 'LIK066 50mg bid (Epoch 3)', 'LIK066 50mg qd (Epoch 3)', 'LIK066 5mg bid (Epoch 3)', 'LIK066 bid/LIK066 35mg qd (Epoch 4)', 'LIK066 qd/LIK066 25mg qd (Epoch 4)', 'Placebo/LIK066 25mg qd (Epoch 4)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo (Epoch 3)', 'Placebo/Placebo (Epoch 4)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.61713, 'lon': -121.32828}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '90017', 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