Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-30 @ 12:43 AM
Study NCT ID:
NCT01218204
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2010-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'C587902', 'term': '(1-(3-isopropyl-1,2,4-oxadiazol-5-yl)piperidin-4-yl)methyl methanesulfonate'}, {'id': 'D000069438', 'term': 'Ezetimibe'}, {'id': 'C573645', 'term': 'WASH protein, Drosophila'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D001384', 'term': 'Azetidines'}, {'id': 'D001385', 'term': 'Azetines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs and SAEs were collected up to follow-up visit. For Part A- up to Day 26, for Part B (washout)- up to Day 28, for Part B (run-in)- up to day up to day 28 and Part B (treatment)- up to Day 26', 'description': 'All AEs and SAEs for Part A were collected using Safety Population and for Part B using All Subjects Population.', 'eventGroups': [{'id': 'EG000', 'title': '80 mg Atorvastatin + 800 mg GSK1292263 (Part A)', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '800 mg GSK1292263 (Part A)', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Pre-treatment (Part B)', 'description': 'This was the time period prior to Day 1 of Washout Phase.', 'otherNumAtRisk': 281, 'deathsNumAtRisk': 281, 'otherNumAffected': 14, 'seriousNumAtRisk': 281, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Washout (Part B)', 'description': 'During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.', 'otherNumAtRisk': 281, 'deathsNumAtRisk': 281, 'otherNumAffected': 37, 'seriousNumAtRisk': 281, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Atorvastatin 10 mg (Part B Run-in)', 'description': 'After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 19, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Atorvastatin 80 mg (Part B Run-in)', 'description': 'After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 8, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg (Part B Treatment)', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg (Part B Treatment)', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg (Part B Treatment)', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Atorvastatin 10 mg + Placebo (Part B Treatment)', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg (Part B Treatment)', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg (Part B Treatment)', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Atorvastatin 80 mg + Placebo (Part B Treatment)', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 4, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'GSK1292263 100 mg (Part B Treatment)', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 5, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'GSK1292263 300 mg (Part B Treatment)', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'GSK1292263 800 mg (Part B Treatment)', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 8, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'Placebo (Part B Treatment)', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 4, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Breast abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 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{'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Personality change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 1}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 281, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 13, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '80 mg Atorvastatin + 800 mg GSK1292263', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': '800 mg GSK1292263', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population consisted of all participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any AEs and SAEs- Part B (Washout)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-treatment', 'description': 'This was the time period prior to Day 1 of Washout Phase.'}, {'id': 'OG001', 'title': 'Washout', 'description': 'During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject Population consisted of all participants who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any AEs and SAEs- Part B (Run-in)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.'}, {'id': 'OG001', 'title': 'Atorvastatin 80 mg', 'description': 'After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '8', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject Population'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': 'GSK1292263 800 mg', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'Single ECGs were taken after admission on Day -1 and at Follow-up (up to Day 26). On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No value found to be abnormal clinically significant in Part A of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Washout', 'description': 'During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'ECGs were taken at Screening, and on Day1 and Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.'}, {'id': 'OG001', 'title': 'Atorvastatin 80 mg', 'description': 'After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'ECGs were taken on Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No data found to be abnormal clinically significant in run-in phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population. Only those participants present during Run in/Day 28 were evaluated/included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'Single ECGs were taken after admission on Day -2, and pre-breakfast on Days -1, 4, 10, and at Follow-up. On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. The data was found to be abnormal clinically significant in treatment phase.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Signs of Potential Clinical Importance (PCI)- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': 'GSK1292263 800 mg', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'DBP, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'DBP, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'Assessment of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate was performed after admission on Day -1 and at Follow-up. On Days 1, 7 and 14, they were taken at pre-dose, 1, 3, 6, 8, 14 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Signs of PCI- Part B (Washout)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Washout', 'description': 'During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.'}], 'classes': [{'title': 'SBP, high', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Heart rate, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 28', 'description': 'Assessment of vital signs including SBP, DBP heart rate was performed at Screening, on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Run-in)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.'}, {'id': 'OG001', 'title': 'Atorvastatin 80 mg', 'description': 'After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.'}], 'classes': [{'title': 'SBP, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 28', 'description': 'Assessment of vital signs including SBP, DBP and heart rate was performed on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'SBP, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'DBP, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'DBP, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Heart rate, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'Assessment of vital signs including SBP, DBP and heart rate was performed after admission on Day-2, and pre-breakfast on Days -1, 4, and 10 in a fasting state early in the morning (prior to dosing), and at Follow-up. On Days 1, 7 and 14, they were also be taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Hematology Value of PCI- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': 'GSK1292263 800 mg', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Hematocrit, high', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, high', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophil, low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'Blood samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Data for only those parameters (Hematocrit, Hemoglobin and Total neutrophils) are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Washout', 'description': 'During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.'}], 'classes': [{'title': 'WBC, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'WBC, low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Total neutrophil, low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit, high', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes, low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Blood samples were collected at screening, and on Days 1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (White blood cells \\[WBC\\], Total neutrophils, Hematocrit and Lymphocytes) are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Hematology Value of PCI- Part B (Run-in)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.'}, {'id': 'OG001', 'title': 'Atorvastatin 80 mg', 'description': 'After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.'}], 'classes': [{'title': 'Lymphocytes, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 14 and 28', 'description': 'Blood samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Lymphocytes) are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Hematology Value of PCI- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Platelet count, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Total neutrophils, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}]}, {'title': 'Lymphocytes, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'Blood samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24hrs post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24hrs post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Platelet count, Total neutrophils and Lymphocytes) are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': 'GSK1292263 800 mg', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'Samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). No parameter was found to have any value of PCI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Washout', 'description': 'During the 4 weeks washout period, participants were asked to stop their lipid-modifying drugs.'}], 'classes': [{'title': 'Inorganic phosphorus, high', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Inorganic phosphorus, low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ALT, high', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, high', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, high', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Magnesium, high', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, high', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Total bilirubin, high', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'CO2/bicarbonate, low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'AST, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 28', 'description': 'Samples were collected at screening, and on Days1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Inorganic phosphorus, Sodium, Alanine aminotransferase \\[ALT\\], Potassium, Creatinine, Calcium, magnesium, Glucose, Total Bilirubin, Carbon dioxide/bicarbonate \\[CO2/HCO3\\] and Aspartate aminotransferase \\[AST\\]) are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg', 'description': 'After washout participants received atorvastatin 10 mg for a 4-week stabilization Run-in Period.'}, {'id': 'OG001', 'title': 'Atorvastatin 80 mg', 'description': 'After washout participants received atorvastatin 80 mg for a 4-week stabilization Run-in Period.'}], 'classes': [{'title': 'Glucose, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium, high', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'ALT, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AST, high', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Calcium, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inorganic phosphorus, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total bilirubin, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Days 14 and 28', 'description': 'Samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Glucose, Magnesium, ALT, AST, Calcium, Inorganic phosphorus and Total bilirubin) are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Glucose, high', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Glucose, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Total bilirubin, high', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}]}, {'title': 'Albumin, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Magnesium, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}]}, {'title': 'CO2/HCO3, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}]}, {'title': 'CO2/HCO3, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Calcium, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Calcium, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'ALT, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'AST, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Inorganic phosphorus, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Potassium, low', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}, {'title': 'Sodium, high', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 26', 'description': 'Samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24 hours post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Glucose, Total bilirubin, Albumin, Magnesium, CO2/HCO3, Calcium, ALT, AST, Inorganic phosphorus, Potassium and Sodium) are presented for which findings are of PCI either high or low.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) of GSK1292263- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': 'GSK1292263 800 mg', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '976.335', 'spread': '16.6353', 'groupId': 'OG000'}, {'value': '986.811', 'spread': '46.4825', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1118.344', 'spread': '20.6141', 'groupId': 'OG000'}, {'value': '948.764', 'spread': '6.5356', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Serial blood samples for the determination of the PK for GSK1292263 on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) Parameter Population was defined as participants in the 'PK Concentration' population for whom PK parameters were derived. The 'PK Concentration Population' was defined as participants in the 'All Subjects' Population for whom a PK sample was obtained and analyzed."}, {'type': 'PRIMARY', 'title': 'Cmax of GSK1292263- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '281.321', 'spread': '35.9671', 'groupId': 'OG000'}, {'value': '475.297', 'spread': '36.5131', 'groupId': 'OG001'}, {'value': '808.278', 'spread': '20.0646', 'groupId': 'OG002'}, {'value': '790.315', 'spread': '32.5080', 'groupId': 'OG003'}, {'value': '263.279', 'spread': '43.0140', 'groupId': 'OG004'}, {'value': '478.676', 'spread': '21.2079', 'groupId': 'OG005'}, {'value': '787.922', 'spread': '36.7864', 'groupId': 'OG006'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '361.595', 'spread': '25.9981', 'groupId': 'OG000'}, {'value': '639.687', 'spread': '33.6608', 'groupId': 'OG001'}, {'value': '886.418', 'spread': '31.3931', 'groupId': 'OG002'}, {'value': '848.082', 'spread': '25.1892', 'groupId': 'OG003'}, {'value': '364.936', 'spread': '39.1918', 'groupId': 'OG004'}, {'value': '590.949', 'spread': '20.7601', 'groupId': 'OG005'}, {'value': '782.914', 'spread': '81.2992', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time of Occurrence of Cmax (Tmax) and Terminal Phase Half-life (t1/2) GSK1292263- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': 'GSK1292263 800 mg', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'tmax, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '8.00'}, {'value': '5.000', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '6.00'}]}]}, {'title': 'tmax, Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '4.00'}, {'value': '5.067', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '6.13'}]}]}, {'title': 't1/2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.185', 'groupId': 'OG000', 'lowerLimit': '8.81', 'upperLimit': '11.61'}, {'value': '16.164', 'groupId': 'OG001', 'lowerLimit': '16.164', 'upperLimit': '16.164'}]}]}, {'title': 't1/2, Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.629', 'groupId': 'OG000', 'lowerLimit': '13.76', 'upperLimit': '28.80'}, {'value': '19.395', 'groupId': 'OG001', 'lowerLimit': '16.54', 'upperLimit': '22.25'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of GSK1292263- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': 'GSK1292263 800 mg', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Serial blood samples for the determination of the PK for GSK1292263 on Days 1 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48h sample on Day 1).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population'}, {'type': 'PRIMARY', 'title': 'Tmax and t1/2 of GSK1292263- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}], 'classes': [{'title': 'tmax, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '3.983', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '6.00'}, {'value': '5.008', 'groupId': 'OG001', 'lowerLimit': '3.98', 'upperLimit': '8.00'}, {'value': '4.000', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '8.33'}, {'value': '4.000', 'groupId': 'OG003', 'lowerLimit': '3.98', 'upperLimit': '8.08'}, {'value': '4.000', 'groupId': 'OG004', 'lowerLimit': '1.50', 'upperLimit': '8.00'}, {'value': '4.000', 'groupId': 'OG005', 'lowerLimit': '2.00', 'upperLimit': '8.00'}, {'value': '3.475', 'groupId': 'OG006', 'lowerLimit': '1.98', 'upperLimit': '7.97'}]}]}, {'title': 'tmax, Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '5.000', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '8.00'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '2.08', 'upperLimit': '4.02'}, {'value': '4.000', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '4.05'}, {'value': '4.000', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '4.00'}, {'value': '4.000', 'groupId': 'OG004', 'lowerLimit': '3.98', 'upperLimit': '6.00'}, {'value': '3.983', 'groupId': 'OG005', 'lowerLimit': '1.98', 'upperLimit': '6.00'}, {'value': '4.000', 'groupId': 'OG006', 'lowerLimit': '0.43', 'upperLimit': '5.98'}]}]}, {'title': 't1/2, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '12.630', 'groupId': 'OG000', 'lowerLimit': '12.63', 'upperLimit': '12.63'}, {'value': '10.270', 'groupId': 'OG001', 'lowerLimit': '6.07', 'upperLimit': '10.55'}, {'value': '10.416', 'groupId': 'OG002', 'lowerLimit': '9.29', 'upperLimit': '26.11'}, {'value': '12.372', 'groupId': 'OG003', 'lowerLimit': '6.72', 'upperLimit': '23.08'}, {'value': '15.305', 'groupId': 'OG004', 'lowerLimit': '12.25', 'upperLimit': '21.78'}, {'value': '14.342', 'groupId': 'OG005', 'lowerLimit': '13.38', 'upperLimit': '20.30'}, {'value': '14.464', 'groupId': 'OG006', 'lowerLimit': '14.464', 'upperLimit': '14.464'}]}]}, {'title': 't1/2, Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '26.453', 'groupId': 'OG000', 'lowerLimit': '17.02', 'upperLimit': '163.25'}, {'value': '21.569', 'groupId': 'OG001', 'lowerLimit': '15.73', 'upperLimit': '37.15'}, {'value': '21.846', 'groupId': 'OG002', 'lowerLimit': '10.52', 'upperLimit': '36.52'}, {'value': '24.225', 'groupId': 'OG003', 'lowerLimit': '16.86', 'upperLimit': '34.21'}, {'value': '23.893', 'groupId': 'OG004', 'lowerLimit': '17.43', 'upperLimit': '43.62'}, {'value': '25.203', 'groupId': 'OG005', 'lowerLimit': '10.67', 'upperLimit': '62.63'}, {'value': '19.478', 'groupId': 'OG006', 'lowerLimit': '12.40', 'upperLimit': '67.78'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tlag of GSK1292263- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.000', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '1.03'}, {'value': '0.000', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.000', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '1.03'}, {'value': '0.000', 'groupId': 'OG005', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '0.000', 'groupId': 'OG006', 'lowerLimit': '0.00', 'upperLimit': '0.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.', 'description': 'Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours [AUC(0-24)] of GSK1292263- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}, {'id': 'OG001', 'title': 'GSK1292263 800 mg', 'description': 'Participants not on lipid-modifying treatment received GSK1282263 alone for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12953.89', 'spread': '16.976', 'groupId': 'OG000'}, {'value': '12032.21', 'spread': 'NA', 'comment': 'Only one participant was analyzed.', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13206.52', 'spread': '15.070', 'groupId': 'OG000'}, {'value': '11890.40', 'spread': '5.730', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).', 'unitOfMeasure': 'nanograms hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC(0-24) of GSK1292263- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4218.02', 'spread': '54.264', 'groupId': 'OG000'}, {'value': '5373.78', 'spread': '64.021', 'groupId': 'OG001'}, {'value': '10384.24', 'spread': '15.165', 'groupId': 'OG002'}, {'value': '9812.21', 'spread': '25.708', 'groupId': 'OG003'}, {'value': '2753.61', 'spread': '48.535', 'groupId': 'OG004'}, {'value': '5342.77', 'spread': '18.108', 'groupId': 'OG005'}, {'value': '8937.99', 'spread': '21.080', 'groupId': 'OG006'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4968.29', 'spread': '24.683', 'groupId': 'OG000'}, {'value': '7484.67', 'spread': '51.772', 'groupId': 'OG001'}, {'value': '11224.58', 'spread': '44.087', 'groupId': 'OG002'}, {'value': '10760.74', 'spread': '22.081', 'groupId': 'OG003'}, {'value': '4061.78', 'spread': '35.242', 'groupId': 'OG004'}, {'value': '6737.82', 'spread': '28.082', 'groupId': 'OG005'}, {'value': '8837.31', 'spread': '79.003', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).', 'unitOfMeasure': 'nanograms hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Trough Concentration of GSK1292263', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}], 'timeFrame': 'On Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Trough samples for GSK1292263 PK (all treatment arms) were planned to be collected early in the morning on Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48h PK sample was collected on Day 16). (pre-dose for Days 13 and 14; trough Day 15 = 24h post last dose; trough Day 16 = 48h post last dose).', 'reportingStatus': 'POSTED', 'populationDescription': 'PK concentration Population. Data was not collected for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Cmax of Atorvastatin- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Day -1', 'categories': [{'measurements': [{'value': '45.587', 'spread': '130.4168', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '25.867', 'spread': '88.8156', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '38.443', 'spread': '71.1418', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population.'}, {'type': 'PRIMARY', 'title': 'Cmax of Atorvastatin- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.045', 'spread': '41.3980', 'groupId': 'OG000'}, {'value': '2.454', 'spread': '34.6820', 'groupId': 'OG001'}, {'value': '1.683', 'spread': '54.1388', 'groupId': 'OG002'}, {'value': '1.816', 'spread': '54.6608', 'groupId': 'OG003'}, {'value': '2.003', 'spread': '73.2912', 'groupId': 'OG004'}, {'value': '42.376', 'spread': '113.1276', 'groupId': 'OG005'}, {'value': '37.058', 'spread': '47.5590', 'groupId': 'OG006'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.292', 'spread': '26.6345', 'groupId': 'OG000'}, {'value': '2.195', 'spread': '47.6989', 'groupId': 'OG001'}, {'value': '1.926', 'spread': '47.0899', 'groupId': 'OG002'}, {'value': '1.852', 'spread': '57.6472', 'groupId': 'OG003'}, {'value': '1.872', 'spread': '64.1762', 'groupId': 'OG004'}, {'value': '31.018', 'spread': '81.5136', 'groupId': 'OG005'}, {'value': '45.781', 'spread': '38.4790', 'groupId': 'OG006'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.453', 'spread': '14.5258', 'groupId': 'OG000'}, {'value': '2.154', 'spread': '69.0856', 'groupId': 'OG001'}, {'value': '2.139', 'spread': '74.2524', 'groupId': 'OG002'}, {'value': '1.640', 'spread': '68.6754', 'groupId': 'OG003'}, {'value': '1.949', 'spread': '56.7747', 'groupId': 'OG004'}, {'value': '38.419', 'spread': '71.2059', 'groupId': 'OG005'}, {'value': '41.092', 'spread': '73.0152', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Tmax of Atorvastatin- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Day -1', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '4.00'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.000', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '6.00'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2.250', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population.'}, {'type': 'PRIMARY', 'title': 'Tmax of Atorvastatin- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '2.500', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '6.08'}, {'value': '3.000', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '6.00'}, {'value': '3.983', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '5.97'}, {'value': '3.017', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '6.08'}, {'value': '4.000', 'groupId': 'OG004', 'lowerLimit': '3.00', 'upperLimit': '4.00'}, {'value': '2.508', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '6.00'}, {'value': '1.517', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '4.00'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.992', 'groupId': 'OG000', 'lowerLimit': '3.98', 'upperLimit': '6.00'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '3.95', 'upperLimit': '6.00'}, {'value': '3.000', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '8.33'}, {'value': '3.992', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '6.08'}, {'value': '4.000', 'groupId': 'OG004', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.492', 'groupId': 'OG005', 'lowerLimit': '1.03', 'upperLimit': '6.03'}, {'value': '2.000', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '4.00'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.000', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '6.00'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '6.00'}, {'value': '3.500', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '6.08'}, {'value': '3.525', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '6.00'}, {'value': '2.000', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '3.00'}, {'value': '2.067', 'groupId': 'OG005', 'lowerLimit': '0.50', 'upperLimit': '5.93'}, {'value': '3.000', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '6.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'AUC (0-24) of Atorvastatin- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Day -1', 'categories': [{'measurements': [{'value': '219.27', 'spread': '77.893', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '199.15', 'spread': '73.974', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '187.25', 'spread': '52.566', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).', 'unitOfMeasure': 'nanograms hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population.'}, {'type': 'PRIMARY', 'title': 'AUC (0-24) of Atorvastatin- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '23.16', 'spread': '18.115', 'groupId': 'OG000'}, {'value': '28.78', 'spread': '26.611', 'groupId': 'OG001'}, {'value': '19.26', 'spread': '54.767', 'groupId': 'OG002'}, {'value': '18.77', 'spread': '51.122', 'groupId': 'OG003'}, {'value': '19.59', 'spread': '47.952', 'groupId': 'OG004'}, {'value': '188.88', 'spread': '70.744', 'groupId': 'OG005'}, {'value': '173.62', 'spread': '31.333', 'groupId': 'OG006'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '17.84', 'spread': '35.028', 'groupId': 'OG000'}, {'value': '26.19', 'spread': '30.561', 'groupId': 'OG001'}, {'value': '20.83', 'spread': '50.427', 'groupId': 'OG002'}, {'value': '19.33', 'spread': '55.620', 'groupId': 'OG003'}, {'value': '19.05', 'spread': '48.448', 'groupId': 'OG004'}, {'value': '174.13', 'spread': '55.829', 'groupId': 'OG005'}, {'value': '186.73', 'spread': '35.837', 'groupId': 'OG006'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '15.58', 'spread': '14.934', 'groupId': 'OG000'}, {'value': '23.77', 'spread': '38.501', 'groupId': 'OG001'}, {'value': '20.41', 'spread': '70.602', 'groupId': 'OG002'}, {'value': '18.60', 'spread': '56.102', 'groupId': 'OG003'}, {'value': '20.24', 'spread': '41.371', 'groupId': 'OG004'}, {'value': '174.93', 'spread': '59.199', 'groupId': 'OG005'}, {'value': '188.31', 'spread': '54.020', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).', 'unitOfMeasure': 'nanograms hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Trough Concentration of Atorvastatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}], 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were planned to be collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were planned to be collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were planned to be collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was planned to be collected on Day 16).', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Data was not collected for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline for Lipid Metabolism: Apolipoprotein A1 and Apolipoprotein B100 at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Apolipoprotein A1, 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '-1.93', 'spread': '27.152', 'groupId': 'OG000'}, {'value': '-8.72', 'spread': '31.791', 'groupId': 'OG001'}, {'value': '4.17', 'spread': '38.410', 'groupId': 'OG002'}, {'value': '-7.19', 'spread': '27.383', 'groupId': 'OG003'}, {'value': '-3.88', 'spread': '26.818', 'groupId': 'OG004'}, {'value': '-1.00', 'spread': '35.805', 'groupId': 'OG005'}, {'value': '-5.81', 'spread': '47.800', 'groupId': 'OG006'}, {'value': '3.76', 'spread': '41.281', 'groupId': 'OG007'}, {'value': '29.90', 'spread': '99.331', 'groupId': 'OG008'}, {'value': '-0.15', 'spread': '39.226', 'groupId': 'OG009'}, {'value': '-0.18', 'spread': '49.478', 'groupId': 'OG010'}]}]}, {'title': 'Apolipoprotein B100, 24 hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '2.85', 'spread': '31.217', 'groupId': 'OG000'}, {'value': '-17.93', 'spread': '19.839', 'groupId': 'OG001'}, {'value': '-22.22', 'spread': '20.393', 'groupId': 'OG002'}, {'value': '-5.03', 'spread': '19.932', 'groupId': 'OG003'}, {'value': '-15.49', 'spread': '13.681', 'groupId': 'OG004'}, {'value': '-27.08', 'spread': '14.132', 'groupId': 'OG005'}, {'value': '4.25', 'spread': '27.890', 'groupId': 'OG006'}, {'value': '-10.21', 'spread': '22.072', 'groupId': 'OG007'}, {'value': '-7.62', 'spread': '23.573', 'groupId': 'OG008'}, {'value': '-10.95', 'spread': '23.811', 'groupId': 'OG009'}, {'value': '-2.39', 'spread': '15.932', 'groupId': 'OG010'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.473', 'ciLowerLimit': '-15.7096', 'ciUpperLimit': '26.6553', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein A1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.598', 'ciLowerLimit': '-21.7840', 'ciUpperLimit': '20.5888', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein A1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.906', 'ciLowerLimit': '-9.3489', 'ciUpperLimit': '33.1602', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.671', 'ciLowerLimit': '-16.9957', 'ciUpperLimit': '24.3384', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein A1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.618', 'ciLowerLimit': '-28.2069', 'ciUpperLimit': '37.4425', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein A1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.713', 'ciLowerLimit': '-17.0405', 'ciUpperLimit': '39.8527', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'GSK1292263 100 mg vs Placebo: Apolipoprotein A1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.934', 'ciLowerLimit': '-21.0153', 'ciUpperLimit': '31.5504', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'GSK1292263 300 mg vs Placebo: Apolipoprotein A1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.466', 'ciLowerLimit': '-23.7517', 'ciUpperLimit': '24.7608', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'GSK1292263 800 mg vs Placebo: Apolipoprotein A1', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.743', 'ciLowerLimit': '-3.2460', 'ciUpperLimit': '33.7161', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'Atorvastatin 10 mg + GSK1292263 100 mg vs Placebo: Apolipoprotein B100', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.428', 'ciLowerLimit': '-21.3243', 'ciUpperLimit': '8.9224', 'estimateComment': 'Statistical analysis was performed using LS mean value Atorvastatin', 'groupDescription': 'Atorvastatin 10 mg + GSK1292263 300 mg vs Placebo: Apolipoprotein B100', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.960', 'ciLowerLimit': '-26.8137', 'ciUpperLimit': '1.1513', 'estimateComment': 'Statistical analysis was performed using LS mean value Atorvastatin', 'groupDescription': 'Atorvastatin 10 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.903', 'ciLowerLimit': '-16.6557', 'ciUpperLimit': '13.1191', 'estimateComment': 'Statistical analysis was performed using LS mean value Atorvastatin', 'groupDescription': 'Atorvastatin 10 mg + Ezetimibe 10 mg vs Placebo: Apolipoprotein B100', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.231', 'ciLowerLimit': '-45.1045', 'ciUpperLimit': '-11.3579', 'estimateComment': 'Statistical analysis was performed using LS mean value Atorvastatin', 'groupDescription': 'Atorvastatin 80 mg + GSK1292263 800 mg vs Placebo: Apolipoprotein B100', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.100', 'ciLowerLimit': '-23.5021', 'ciUpperLimit': '11.3014', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'GSK1292263 100 mg vs Placebo: Apolipoprotein B100', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.490', 'ciLowerLimit': '-25.2721', 'ciUpperLimit': '8.2918', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'GSK1292263 300 mg vs Placebo: Apolipoprotein B100', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.687', 'ciLowerLimit': '-26.0247', 'ciUpperLimit': '6.6498', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'GSK1292263 800 mg vs Placebo: Apolipoprotein B100', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Lipid Metabolism: Apolipoprotein E at Day 14 (24 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.97', 'spread': '16.373', 'groupId': 'OG000'}, {'value': '-3.92', 'spread': '29.382', 'groupId': 'OG001'}, {'value': '-31.41', 'spread': '17.369', 'groupId': 'OG002'}, {'value': '34.28', 'spread': '141.042', 'groupId': 'OG003'}, {'value': '-12.27', 'spread': '42.191', 'groupId': 'OG004'}, {'value': '-13.19', 'spread': '19.202', 'groupId': 'OG005'}, {'value': '-13.41', 'spread': '30.613', 'groupId': 'OG006'}, {'value': '1.35', 'spread': '46.155', 'groupId': 'OG007'}, {'value': '-21.98', 'spread': '37.910', 'groupId': 'OG008'}, {'value': '-33.75', 'spread': '16.915', 'groupId': 'OG009'}, {'value': '-1.58', 'spread': '36.044', 'groupId': 'OG010'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.471', 'ciLowerLimit': '-47.9323', 'ciUpperLimit': '3.2020', 'estimateComment': 'Statistical analysis was performed using LS mean value Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.910', 'ciLowerLimit': '-38.1027', 'ciUpperLimit': '25.3126', 'estimateComment': 'Statistical analysis was performed using LS mean value Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.985', 'ciLowerLimit': '-45.5492', 'ciUpperLimit': '1.8605', 'estimateComment': 'Statistical analysis was performed using LS mean value Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.697', 'ciLowerLimit': '-45.0846', 'ciUpperLimit': '13.3024', 'estimateComment': 'Statistical analysis was performed using LS mean value Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.036', 'ciLowerLimit': '-27.2281', 'ciUpperLimit': '15.1569', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.198', 'ciLowerLimit': '-24.2901', 'ciUpperLimit': '32.6057', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.117', 'ciLowerLimit': '-40.4767', 'ciUpperLimit': '1.9060', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.798', 'ciLowerLimit': '-48.3842', 'ciUpperLimit': '-12.5064', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.', 'unitOfMeasure': 'Perecent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'HDLc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '7.50', 'spread': '13.639', 'groupId': 'OG000'}, {'value': '14.97', 'spread': '7.700', 'groupId': 'OG001'}, {'value': '31.09', 'spread': '11.966', 'groupId': 'OG002'}, {'value': '-0.03', 'spread': '14.714', 'groupId': 'OG003'}, {'value': '6.03', 'spread': '11.850', 'groupId': 'OG004'}, {'value': '26.22', 'spread': '15.840', 'groupId': 'OG005'}, {'value': '4.50', 'spread': '10.936', 'groupId': 'OG006'}, {'value': '9.17', 'spread': '10.277', 'groupId': 'OG007'}, {'value': '9.76', 'spread': '17.160', 'groupId': 'OG008'}, {'value': '18.95', 'spread': '12.847', 'groupId': 'OG009'}, {'value': '-1.37', 'spread': '7.140', 'groupId': 'OG010'}]}]}, {'title': 'LDLc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '-6.80', 'spread': '14.522', 'groupId': 'OG000'}, {'value': '-10.01', 'spread': '21.231', 'groupId': 'OG001'}, {'value': '-24.09', 'spread': '18.017', 'groupId': 'OG002'}, {'value': '-0.37', 'spread': '19.794', 'groupId': 'OG003'}, {'value': '-24.81', 'spread': '12.317', 'groupId': 'OG004'}, {'value': '-18.63', 'spread': '16.534', 'groupId': 'OG005'}, {'value': '15.01', 'spread': '59.194', 'groupId': 'OG006'}, {'value': '-10.24', 'spread': '11.438', 'groupId': 'OG007'}, {'value': '-11.86', 'spread': '16.873', 'groupId': 'OG008'}, {'value': '-19.94', 'spread': '10.688', 'groupId': 'OG009'}, {'value': '0.77', 'spread': '11.347', 'groupId': 'OG010'}]}]}, {'title': 'Triglyceides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '-18.67', 'spread': '16.693', 'groupId': 'OG000'}, {'value': '-15.98', 'spread': '24.307', 'groupId': 'OG001'}, {'value': '-32.81', 'spread': '21.249', 'groupId': 'OG002'}, {'value': '10.70', 'spread': '32.177', 'groupId': 'OG003'}, {'value': '-10.44', 'spread': '21.628', 'groupId': 'OG004'}, {'value': '-21.39', 'spread': '28.190', 'groupId': 'OG005'}, {'value': '2.27', 'spread': '17.025', 'groupId': 'OG006'}, {'value': '-3.95', 'spread': '23.855', 'groupId': 'OG007'}, {'value': '-30.84', 'spread': '11.753', 'groupId': 'OG008'}, {'value': '-34.66', 'spread': '21.197', 'groupId': 'OG009'}, {'value': '18.90', 'spread': '18.225', 'groupId': 'OG010'}]}]}, {'title': 'Non-HDLc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '-9.53', 'spread': '8.502', 'groupId': 'OG000'}, {'value': '-11.67', 'spread': '18.562', 'groupId': 'OG001'}, {'value': '-26.59', 'spread': '13.742', 'groupId': 'OG002'}, {'value': '2.08', 'spread': '16.176', 'groupId': 'OG003'}, {'value': '-21.19', 'spread': '11.920', 'groupId': 'OG004'}, {'value': '-21.88', 'spread': '11.157', 'groupId': 'OG005'}, {'value': '-0.94', 'spread': '8.977', 'groupId': 'OG006'}, {'value': '-9.32', 'spread': '13.107', 'groupId': 'OG007'}, {'value': '-17.02', 'spread': '12.376', 'groupId': 'OG008'}, {'value': '-22.62', 'spread': '10.290', 'groupId': 'OG009'}, {'value': '3.17', 'spread': '9.283', 'groupId': 'OG010'}]}]}, {'title': 'Total cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}]}], 'categories': [{'measurements': [{'value': '-5.17', 'spread': '9.210', 'groupId': 'OG000'}, {'value': '-3.61', 'spread': '12.355', 'groupId': 'OG001'}, {'value': '-10.31', 'spread': '8.912', 'groupId': 'OG002'}, {'value': '0.89', 'spread': '12.671', 'groupId': 'OG003'}, {'value': '-14.23', 'spread': '9.640', 'groupId': 'OG004'}, {'value': '-5.52', 'spread': '7.721', 'groupId': 'OG005'}, {'value': '1.09', 'spread': '6.724', 'groupId': 'OG006'}, {'value': '-5.81', 'spread': '10.091', 'groupId': 'OG007'}, {'value': '-12.06', 'spread': '9.650', 'groupId': 'OG008'}, {'value': '-14.05', 'spread': '7.614', 'groupId': 'OG009'}, {'value': '2.18', 'spread': '7.900', 'groupId': 'OG010'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.101', 'ciLowerLimit': '-4.5469', 'ciUpperLimit': '14.7495', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.273', 'ciLowerLimit': '2.5937', 'ciUpperLimit': '21.9532', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'Fo HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.833', 'ciLowerLimit': '18.9550', 'ciUpperLimit': '38.7102', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.701', 'ciLowerLimit': '-5.5562', 'ciUpperLimit': '12.9578', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.946', 'ciLowerLimit': '8.6120', 'ciUpperLimit': '33.2810', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.561', 'ciLowerLimit': '-0.9675', 'ciUpperLimit': '22.0898', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.122', 'ciLowerLimit': '-0.2902', 'ciUpperLimit': '22.5351', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.689', 'ciLowerLimit': '9.7527', 'ciUpperLimit': '31.6262', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.549', 'ciLowerLimit': '-18.7750', 'ciUpperLimit': '9.6768', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For LDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.337', 'ciLowerLimit': '-24.4549', 'ciUpperLimit': '3.7803', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For LDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.317', 'ciLowerLimit': '-36.0144', 'ciUpperLimit': '-6.6190', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For LDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.173', 'ciLowerLimit': '-34.2710', 'ciUpperLimit': '-6.0755', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For LDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.472', 'ciLowerLimit': '-49.3385', 'ciUpperLimit': '-8.1558', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For LDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.128', 'ciLowerLimit': '-23.3049', 'ciUpperLimit': '-0.9514', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For LDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.798', 'ciLowerLimit': '-27.1364', 'ciUpperLimit': '-4.4589', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For LDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.789', 'ciLowerLimit': '-32.3413', 'ciUpperLimit': '-11.2372', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For LDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.498', 'ciLowerLimit': '-38.4460', 'ciUpperLimit': '-2.4169', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.781', 'ciLowerLimit': '-39.1603', 'ciUpperLimit': '-4.5130', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-39.923', 'ciLowerLimit': '-52.3394', 'ciUpperLimit': '-24.2717', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.444', 'ciLowerLimit': '-33.5020', 'ciUpperLimit': '2.4910', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.781', 'ciLowerLimit': '-40.2960', 'ciUpperLimit': '-3.2667', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.421', 'ciLowerLimit': '-38.3519', 'ciUpperLimit': '-4.4911', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-46.361', 'ciLowerLimit': '-63.4650', 'ciUpperLimit': '-29.2561', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.843', 'ciLowerLimit': '-70.7854', 'ciUpperLimit': '-38.9007', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For Triglycerides', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.756', 'ciLowerLimit': '-21.7561', 'ciUpperLimit': '2.2448', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Non-HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.014', 'ciLowerLimit': '-25.7497', 'ciUpperLimit': '-2.2787', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Non-HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-27.675', 'ciLowerLimit': '-39.8454', 'ciUpperLimit': '-15.5045', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Non-HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.937', 'ciLowerLimit': '-32.6057', 'ciUpperLimit': '-9.2690', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Non-HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.702', 'ciLowerLimit': '-29.0346', 'ciUpperLimit': '-14.3696', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Non-HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.180', 'ciLowerLimit': '-23.0636', 'ciUpperLimit': '-3.2961', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For Non-HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.151', 'ciLowerLimit': '-31.9420', 'ciUpperLimit': '-12.3605', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For Non-HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.948', 'ciLowerLimit': '-36.2874', 'ciUpperLimit': '-17.6092', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For Non-HDLc', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.904', 'ciLowerLimit': '-11.8484', 'ciUpperLimit': '4.0400', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.437', 'ciLowerLimit': '-14.3460', 'ciUpperLimit': '1.4722', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.294', 'ciLowerLimit': '-18.3923', 'ciUpperLimit': '-2.1960', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.065', 'ciLowerLimit': '-19.7688', 'ciUpperLimit': '-4.3609', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.941', 'ciLowerLimit': '-13.9778', 'ciUpperLimit': '-1.9039', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'groupDescription': 'For Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.384', 'ciLowerLimit': '-15.9023', 'ciUpperLimit': '-0.8660', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.700', 'ciLowerLimit': '-23.1404', 'ciUpperLimit': '-8.2592', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'groupDescription': 'For Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.728', 'ciLowerLimit': '-23.8395', 'ciUpperLimit': '-9.6161', 'groupDescription': 'For Cholesterol', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Lipid Metabolism: LDL/HDL Ratio at Day 14 (24 Hours)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '10', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.25', 'spread': '14.784', 'groupId': 'OG000'}, {'value': '-21.12', 'spread': '20.549', 'groupId': 'OG001'}, {'value': '-41.61', 'spread': '14.248', 'groupId': 'OG002'}, {'value': '0.94', 'spread': '20.727', 'groupId': 'OG003'}, {'value': '-28.69', 'spread': '11.963', 'groupId': 'OG004'}, {'value': '-34.35', 'spread': '16.047', 'groupId': 'OG005'}, {'value': '10.84', 'spread': '56.487', 'groupId': 'OG006'}, {'value': '-16.78', 'spread': '15.615', 'groupId': 'OG007'}, {'value': '-17.63', 'spread': '23.327', 'groupId': 'OG008'}, {'value': '-32.01', 'spread': '11.287', 'groupId': 'OG009'}, {'value': '2.55', 'spread': '12.789', 'groupId': 'OG010'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.123', 'ciLowerLimit': '-26.6276', 'ciUpperLimit': '2.3814', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.630', 'ciLowerLimit': '-35.9419', 'ciUpperLimit': '-7.3181', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.506', 'ciLowerLimit': '-56.3924', 'ciUpperLimit': '-26.6205', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-28.041', 'ciLowerLimit': '-42.2554', 'ciUpperLimit': '-13.8263', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.293', 'ciLowerLimit': '-51.5654', 'ciUpperLimit': '-12.4042', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.042', 'ciLowerLimit': '-34.8358', 'ciUpperLimit': '-5.2472', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.903', 'ciLowerLimit': '-36.6155', 'ciUpperLimit': '-7.1913', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-35.735', 'ciLowerLimit': '-49.7220', 'ciUpperLimit': '-21.7485', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'PRIMARY', 'title': 'Weighted Mean Area Under Concentration Curve From 0 to 24 Hours (AUC [0-24]) Change From Baseline for Triglycerides at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}, {'value': '12', 'groupId': 'OG008'}, {'value': '13', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG007', 'title': 'GSK1292263 100 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG008', 'title': 'GSK1292263 300 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG009', 'title': 'GSK1292263 800 mg', 'description': 'After washout, participants were randomized to receive monotherapy of GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG010', 'title': 'Placebo', 'description': 'After washout, participants were randomized to receive placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13341', 'spread': '-167.395', 'groupId': 'OG000'}, {'value': '0.30812', 'spread': '-360.966', 'groupId': 'OG001'}, {'value': '0.12845', 'spread': '-68.4294', 'groupId': 'OG002'}, {'value': '0.25228', 'spread': '477.0380', 'groupId': 'OG003'}, {'value': '0.09060', 'spread': '-146.956', 'groupId': 'OG004'}, {'value': '0.04974', 'spread': '-76.1973', 'groupId': 'OG005'}, {'value': '0.20164', 'spread': '-485.961', 'groupId': 'OG006'}, {'value': '0.30543', 'spread': '-159.012', 'groupId': 'OG007'}, {'value': '0.37442', 'spread': '-111.818', 'groupId': 'OG008'}, {'value': '0.13079', 'spread': '-115.210', 'groupId': 'OG009'}, {'value': '0.28863', 'spread': '93.3050', 'groupId': 'OG010'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.409', 'ciLowerLimit': '-1.0123', 'ciUpperLimit': '0.1942', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.296', 'ciLowerLimit': '-0.9063', 'ciUpperLimit': '0.3141', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.811', 'ciLowerLimit': '-1.4125', 'ciUpperLimit': '-0.2098', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG004', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.422', 'ciLowerLimit': '-0.9831', 'ciUpperLimit': '0.1394', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG005', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.384', 'ciLowerLimit': '-0.6009', 'ciUpperLimit': '-0.1669', 'estimateComment': 'Statistical analysis was performed using LS mean value of Atorvastatin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG007', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.648', 'ciLowerLimit': '-1.1657', 'ciUpperLimit': '-0.1302', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG008', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.782', 'ciLowerLimit': '-1.2804', 'ciUpperLimit': '-0.2844', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG009', 'OG010'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.884', 'ciLowerLimit': '-1.3652', 'ciUpperLimit': '-0.4026', 'estimateComment': 'Statistical analysis was performed using LS mean value of GSK1292263', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was Day -1 value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.', 'unitOfMeasure': 'millimoles per liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Day -1', 'categories': [{'measurements': [{'value': '17.521', 'spread': '66.1066', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '15.535', 'spread': '48.2576', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '21.271', 'spread': '30.4382', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population.'}, {'type': 'SECONDARY', 'title': 'Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.298', 'spread': '37.3615', 'groupId': 'OG000'}, {'value': '1.388', 'spread': '42.8163', 'groupId': 'OG001'}, {'value': '0.947', 'spread': '39.3947', 'groupId': 'OG002'}, {'value': '0.952', 'spread': '63.1814', 'groupId': 'OG003'}, {'value': '1.185', 'spread': '119.9675', 'groupId': 'OG004'}, {'value': '26.106', 'spread': '102.2617', 'groupId': 'OG005'}, {'value': '21.149', 'spread': '39.5618', 'groupId': 'OG006'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '1.073', 'spread': '19.3329', 'groupId': 'OG000'}, {'value': '1.217', 'spread': '36.0597', 'groupId': 'OG001'}, {'value': '1.048', 'spread': '33.9165', 'groupId': 'OG002'}, {'value': '1.028', 'spread': '67.0630', 'groupId': 'OG003'}, {'value': '1.234', 'spread': '44.7679', 'groupId': 'OG004'}, {'value': '19.991', 'spread': '71.2442', 'groupId': 'OG005'}, {'value': '26.400', 'spread': '44.9589', 'groupId': 'OG006'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '0.634', 'spread': '12.5545', 'groupId': 'OG000'}, {'value': '1.152', 'spread': '53.4256', 'groupId': 'OG001'}, {'value': '1.084', 'spread': '49.9097', 'groupId': 'OG002'}, {'value': '0.869', 'spread': '62.0112', 'groupId': 'OG003'}, {'value': '1.349', 'spread': '42.0203', 'groupId': 'OG004'}, {'value': '22.645', 'spread': '75.7161', 'groupId': 'OG005'}, {'value': '27.236', 'spread': '68.7891', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Day -1', 'categories': [{'measurements': [{'value': '3.000', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '4.000', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '6.00'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2.500', 'groupId': 'OG000', 'lowerLimit': '2.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population.'}, {'type': 'SECONDARY', 'title': 'Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '4.500', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.08'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '8.00'}, {'value': '5.000', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '8.02'}, {'value': '4.000', 'groupId': 'OG003', 'lowerLimit': '3.00', 'upperLimit': '8.00'}, {'value': '4.000', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '6.00'}, {'value': '3.992', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '3.000', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '6.00'}, {'value': '6.000', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '8.00'}, {'value': '4.000', 'groupId': 'OG002', 'lowerLimit': '2.00', 'upperLimit': '14.10'}, {'value': '4.000', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '10.00'}, {'value': '4.000', 'groupId': 'OG004', 'lowerLimit': '2.00', 'upperLimit': '6.00'}, {'value': '4.000', 'groupId': 'OG005', 'lowerLimit': '1.50', 'upperLimit': '6.08'}, {'value': '3.000', 'groupId': 'OG006', 'lowerLimit': '0.50', 'upperLimit': '6.02'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '6.000', 'groupId': 'OG000', 'lowerLimit': '2.83', 'upperLimit': '8.00'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '14.00'}, {'value': '4.025', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '6.08'}, {'value': '5.000', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '14.02'}, {'value': '6.000', 'groupId': 'OG004', 'lowerLimit': '3.00', 'upperLimit': '6.00'}, {'value': '4.000', 'groupId': 'OG005', 'lowerLimit': '1.50', 'upperLimit': '6.00'}, {'value': '3.983', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '6.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose and on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants on 80 mg atorvastatin (either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg) received 800 mg of GSK1292263 for 2 weeks once daily immediately after eating the breakfast meal.'}], 'classes': [{'title': 'Day -1', 'categories': [{'measurements': [{'value': '119.66', 'spread': '72.635', 'groupId': 'OG000'}]}]}, {'title': 'Day 1', 'categories': [{'measurements': [{'value': '127.70', 'spread': '49.098', 'groupId': 'OG000'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '139.78', 'spread': '47.491', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).', 'unitOfMeasure': 'nanograms hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population.'}, {'type': 'SECONDARY', 'title': 'AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}], 'classes': [{'title': 'Day -1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '12', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '16.72', 'spread': '19.509', 'groupId': 'OG000'}, {'value': '20.25', 'spread': '47.047', 'groupId': 'OG001'}, {'value': '14.37', 'spread': '48.598', 'groupId': 'OG002'}, {'value': '12.38', 'spread': '74.286', 'groupId': 'OG003'}, {'value': '12.41', 'spread': '53.128', 'groupId': 'OG004'}, {'value': '163.16', 'spread': '73.666', 'groupId': 'OG005'}, {'value': '133.96', 'spread': '36.159', 'groupId': 'OG006'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '16.02', 'spread': '9.355', 'groupId': 'OG000'}, {'value': '18.28', 'spread': '40.611', 'groupId': 'OG001'}, {'value': '14.89', 'spread': '33.541', 'groupId': 'OG002'}, {'value': '13.60', 'spread': '78.379', 'groupId': 'OG003'}, {'value': '15.10', 'spread': '26.181', 'groupId': 'OG004'}, {'value': '146.23', 'spread': '55.353', 'groupId': 'OG005'}, {'value': '150.41', 'spread': '37.440', 'groupId': 'OG006'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}, {'value': '13', 'groupId': 'OG006'}]}], 'categories': [{'measurements': [{'value': '10.07', 'spread': '12.346', 'groupId': 'OG000'}, {'value': '16.54', 'spread': '37.123', 'groupId': 'OG001'}, {'value': '13.82', 'spread': '43.131', 'groupId': 'OG002'}, {'value': '12.03', 'spread': '63.145', 'groupId': 'OG003'}, {'value': '18.18', 'spread': '36.758', 'groupId': 'OG004'}, {'value': '144.23', 'spread': '58.954', 'groupId': 'OG005'}, {'value': '156.41', 'spread': '42.286', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).', 'unitOfMeasure': 'nanograms hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter Population. Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Trough Concentration of Atorvastatin Metabolite (2-Hydroxyatorvastatin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Atorvastatin 10 mg + GSK1292263 100 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 100 mg once daily for 2 weeks.'}, {'id': 'OG001', 'title': 'Atorvastatin 10 mg + GSK1292263 300 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 300 mg once daily for 2 weeks.'}, {'id': 'OG002', 'title': 'Atorvastatin 10 mg + GSK1292263 800 mg', 'description': 'Participants received 10 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG003', 'title': 'Atorvastatin 10 mg + Placebo', 'description': 'Participants received 10 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}, {'id': 'OG004', 'title': 'Atorvastatin 10 mg + Ezetimibe 10 mg', 'description': 'Participants received 10 mg atorvastatin along with Ezetimibe 10 mg once daily for 2 weeks.'}, {'id': 'OG005', 'title': 'Atorvastatin 80 mg + GSK1292263 800 mg', 'description': 'Participants received 80 mg atorvastatin along with GSK1292263 800 mg once daily for 2 weeks.'}, {'id': 'OG006', 'title': 'Atorvastatin 80 mg + Placebo', 'description': 'Participants received 80 mg atorvastatin along with placebo matching to GSK1292263 once daily for 2 weeks.'}], 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were supposed to collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were supposed to collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were supposed to collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16). However no data was collected.', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A', 'description': 'Four participants on 80 milligrams (mg) atorvastatin \\[either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40mg\\], received GSK1292263 800 mg for 2 weeks, and 2 participants not on lipid-modifying treatment received GSK1282263 800 mg alone for 2 weeks.'}, {'id': 'FG001', 'title': 'Part B Washout', 'description': 'Participants were washed off their prior lipid-lowering therapy for 4 weeks.'}, {'id': 'FG002', 'title': 'Part B Run-in', 'description': 'Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period.'}, {'id': 'FG003', 'title': 'Part B Pooled Treatment Arm', 'description': 'In this pooled arm, after washout, randomized participants were stratified into 11 arms to receive either atorvastatin 10 mg along with 100 mg or 300 mg or 800 mg of GSK129226 or placebo or ezetimibe 10 mg once daily for 2 weeks; or atorvastatin 80 mg along with 800 mg of GSK129226 or placebo once daily for 2 weeks; or monotherapy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) once daily for 2 weeks.'}], 'periods': [{'title': 'Part A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part B Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '281'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Reached defined stopping criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Did not meet continuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '112'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part B Run-in', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '89'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part B Pooled Treatment Arm', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 21 centers in the United States during the period 14 September 2010 to 29 June 2011. There were 6 total participants in Part A, then Part B started with total of 281 participants which flowed through the rest of the phases of the trial. Part B had washout phase and run-In phase followed by treatment phase.', 'preAssignmentDetails': 'Total 130 participants were randomized and received at least one dose of study drug in the treatment period phase. Part B Run-In excludes those participants randomized to monotherapy arms; that is, these participant counts are only those who were receiving Atorvastatin.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A', 'description': 'Four participants on 80 mg atorvastatin \\[either for \\>=4 weeks prior to screening (80 mg), or for 2 weeks, if the dose was escalated from a stable dose of 40 mg\\], received GSK1292263 800 mg for 2 weeks, and 2 participants not on lipid-modifying treatment received GSK1282263 800 mg alone for 2 weeks.'}, {'id': 'BG001', 'title': 'Part B', 'description': 'Part B included Washout phase (Participants were washed off their prior lipid-lowering therapy for 4 weeks), Run-in phase (Eligible participants were randomized to receive 10 mg open-labeled atorvastatin or 80 mg open-labeled atorvastatin for a 4-week stabilization run-in period) and Treatment phase (Randomized participants after washout received monotherpy (100 mg, 300 mg or 800 mg of GSK1292263 or placebo) for 2 weeks. Participants in the 10mg atorvastatin run-in group received GSK1292263, 300 mg QD GSK1292263, 800 mg QD GSK1292263, placebo for GSK1292263 or 10 mg open-label ezetimibe for 2 weeks. Participants in the 80 mg atorvastatin run-in group received 800 mg QD GSK1292263 and placebo for GSK1292263 for 2 weeks)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.2', 'spread': '5.34', 'groupId': 'BG000'}, {'value': '49.2', 'spread': '5.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Data is presented for Part A', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'N=6'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '281', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.7', 'spread': '9.97', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '9.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Data is presented for Part B', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'N=281'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Japanese Heritage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian - South East Asian Heritage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic/North African Heritage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}, {'title': 'White - Mixed Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '281', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'One participant was withdrawn prior to washout period. 34 participants did not complete washout phase. 111 participants did not qualify to continue in the study after completing the Washout Phase. 6 participants were withdrawn during run-in phase and 3 participants were withdrawn during treatment phase.'}}, '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': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'dispFirstSubmitDate': '2015-04-27', 'completionDateStruct': {'date': '2011-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-05', 'studyFirstSubmitDate': '2010-09-23', 'dispFirstSubmitQcDate': '2015-04-27', 'resultsFirstSubmitDate': '2017-08-31', 'studyFirstSubmitQcDate': '2010-10-07', 'dispFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-09', 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A', 'timeFrame': 'Up to Day 26', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.'}, {'measure': 'Number of Participants With Any AEs and SAEs- Part B (Washout)', 'timeFrame': 'Up to Day 28', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.'}, {'measure': 'Number of Participants With Any AEs and SAEs- Part B (Run-in)', 'timeFrame': 'Up to Day 28', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.'}, {'measure': 'Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm)', 'timeFrame': 'Up to Day 26', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.'}, {'measure': 'Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A', 'timeFrame': 'Up to Day 26', 'description': 'Single ECGs were taken after admission on Day -1 and at Follow-up (up to Day 26). On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No value found to be abnormal clinically significant in Part A of the study.'}, {'measure': 'Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout)', 'timeFrame': 'Up to Day 28', 'description': 'ECGs were taken at Screening, and on Day1 and Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings.'}, {'measure': 'Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in)', 'timeFrame': 'Day 28', 'description': 'ECGs were taken on Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No data found to be abnormal clinically significant in run-in phase.'}, {'measure': 'Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm)', 'timeFrame': 'Up to Day 26', 'description': 'Single ECGs were taken after admission on Day -2, and pre-breakfast on Days -1, 4, 10, and at Follow-up. On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. The data was found to be abnormal clinically significant in treatment phase.'}, {'measure': 'Number of Participants With Vital Signs of Potential Clinical Importance (PCI)- Part A', 'timeFrame': 'Up to Day 26', 'description': 'Assessment of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate was performed after admission on Day -1 and at Follow-up. On Days 1, 7 and 14, they were taken at pre-dose, 1, 3, 6, 8, 14 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Vital Signs of PCI- Part B (Washout)', 'timeFrame': 'Up to day 28', 'description': 'Assessment of vital signs including SBP, DBP heart rate was performed at Screening, on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Run-in)', 'timeFrame': 'Up to day 28', 'description': 'Assessment of vital signs including SBP, DBP and heart rate was performed on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Vital Signs of Potential Clinical Importance- Part B (Pooled Treatment Arm)', 'timeFrame': 'Up to Day 26', 'description': 'Assessment of vital signs including SBP, DBP and heart rate was performed after admission on Day-2, and pre-breakfast on Days -1, 4, and 10 in a fasting state early in the morning (prior to dosing), and at Follow-up. On Days 1, 7 and 14, they were also be taken at 1, 3, 6, 9, 12 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Abnormal Hematology Value of PCI- Part A', 'timeFrame': 'Up to Day 26', 'description': 'Blood samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Data for only those parameters (Hematocrit, Hemoglobin and Total neutrophils) are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Abnormal Hematology Value of PCI- Part B (Washout)', 'timeFrame': 'Up to Day 28', 'description': 'Blood samples were collected at screening, and on Days 1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (White blood cells \\[WBC\\], Total neutrophils, Hematocrit and Lymphocytes) are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Abnormal Hematology Value of PCI- Part B (Run-in)', 'timeFrame': 'Days 14 and 28', 'description': 'Blood samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Lymphocytes) are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Abnormal Hematology Value of PCI- Part B (Pooled Treatment Arm)', 'timeFrame': 'Up to Day 26', 'description': 'Blood samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24hrs post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24hrs post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Platelet count, Total neutrophils and Lymphocytes) are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part A', 'timeFrame': 'Up to Day 26', 'description': 'Samples were collected fasting on Day -1, and prior to breakfast (early in the morning, fasting) on Days 2, 4, 7, 11 and on Day 15 prior to checkout (24 hours post last-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). No parameter was found to have any value of PCI.'}, {'measure': 'Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Washout)', 'timeFrame': 'Up to Day 28', 'description': 'Samples were collected at screening, and on Days1 (first day of washout), 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Inorganic phosphorus, Sodium, Alanine aminotransferase \\[ALT\\], Potassium, Creatinine, Calcium, magnesium, Glucose, Total Bilirubin, Carbon dioxide/bicarbonate \\[CO2/HCO3\\] and Aspartate aminotransferase \\[AST\\]) are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (run-in)', 'timeFrame': 'Days 14 and 28', 'description': 'Samples were collected on Day 14 and 28 prior to breakfast (early in the morning, fasting). Data for only those parameters (Glucose, Magnesium, ALT, AST, Calcium, Inorganic phosphorus and Total bilirubin) are presented for which findings are of PCI either high or low.'}, {'measure': 'Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part B (Pooled Treatment Arm)', 'timeFrame': 'Up to Day 26', 'description': 'Samples were collected fasting on Day -2, and prior to breakfast (early in the morning, fasting) on Days 2 (pre-dose), 4, 7, 10, 13 and on Day 15 prior to checkout (24 hours post-dose), and at Follow-up. When this resulted in multiple samples at the same time point, only one sample was collected (example, when 24 hours post dose = pre-dose (time 0) for the next dose). Data for only those parameters (Glucose, Total bilirubin, Albumin, Magnesium, CO2/HCO3, Calcium, ALT, AST, Inorganic phosphorus, Potassium and Sodium) are presented for which findings are of PCI either high or low.'}, {'measure': 'Maximum Observed Concentration (Cmax) of GSK1292263- Part A', 'timeFrame': 'On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Serial blood samples for the determination of the PK for GSK1292263 on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).'}, {'measure': 'Cmax of GSK1292263- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).'}, {'measure': 'Time of Occurrence of Cmax (Tmax) and Terminal Phase Half-life (t1/2) GSK1292263- Part A', 'timeFrame': 'On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).'}, {'measure': 'Lag Time Before Observation of Drug Concentrations in Sampled Matrix (Tlag) of GSK1292263- Part A', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Serial blood samples for the determination of the PK for GSK1292263 on Days 1 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48h sample on Day 1).'}, {'measure': 'Tmax and t1/2 of GSK1292263- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).'}, {'measure': 'Tlag of GSK1292263- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.', 'description': 'Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero (Pre-dose) to 24 Hours [AUC(0-24)] of GSK1292263- Part A', 'timeFrame': 'On Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Serial blood samples for the determination of the PK for GSK1292263, on Days 1 and 14 were collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (no 48 hour sample on Day 1).'}, {'measure': 'AUC(0-24) of GSK1292263- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. On Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of GSK1292263 were taken on Days 1 and 14. For monotherapy arms, serial blood samples for the determination of the PK of GSK1292263 were collected on Days 1 and 14. Blood samples for PK were collected on Day 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hours PK sample was collected on Day 16).'}, {'measure': 'Trough Concentration of GSK1292263', 'timeFrame': 'On Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'Trough samples for GSK1292263 PK (all treatment arms) were planned to be collected early in the morning on Days 13, 14, 15 and 16 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48h PK sample was collected on Day 16). (pre-dose for Days 13 and 14; trough Day 15 = 24h post last dose; trough Day 16 = 48h post last dose).'}, {'measure': 'Cmax of Atorvastatin- Part A', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).'}, {'measure': 'Cmax of Atorvastatin- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).'}, {'measure': 'Tmax of Atorvastatin- Part A', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).'}, {'measure': 'Tmax of Atorvastatin- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).'}, {'measure': 'AUC (0-24) of Atorvastatin- Part A', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).'}, {'measure': 'AUC (0-24) of Atorvastatin- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).'}, {'measure': 'Trough Concentration of Atorvastatin', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin were planned to be collected on Day -1 and for atorvastatin on Days 1 and 14. Blood samples for PK were planned to be collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were planned to be collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was planned to be collected on Day 16).'}, {'measure': 'Percent Change From Baseline for Lipid Metabolism: Apolipoprotein A1 and Apolipoprotein B100 at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.'}, {'measure': 'Percent Change From Baseline in Lipid Metabolism: Apolipoprotein E at Day 14 (24 Hours)', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.'}, {'measure': 'Percent Change From Baseline in Lipid Metabolism: High Density Lipids Cholesterol (HDLc), Low Density Lipids Cholesterol (LDLc), Tryglycerides, Non-HDLc and Total Cholesterol at Day 14 (24 Hours)', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.'}, {'measure': 'Percent Change From Baseline in Lipid Metabolism: LDL/HDL Ratio at Day 14 (24 Hours)', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was the closest scheduled value prior to dosing. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.'}, {'measure': 'Weighted Mean Area Under Concentration Curve From 0 to 24 Hours (AUC [0-24]) Change From Baseline for Triglycerides at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'Blood samples were collected fasting on Days 1 (pre-dose), 7 and 15 prior to checkout (24 hours post-dose), and at Follow-up. When this results in multiple samples at the same time point, only one sample will be collected (example, when 24 hours post-dose = pre-dose (time 0) for the next dose). Baseline was Day -1 value. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values. If either the Baseline or post-randomization value is missing, the change from Baseline was set to missing as well. Percent change from Baseline was calculated as the change from Baseline divided by the Baseline value then multiplied by 100.'}], 'secondaryOutcomes': [{'measure': 'Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).'}, {'measure': 'Cmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).'}, {'measure': 'Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).'}, {'measure': 'Tmax of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose and on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).'}, {'measure': 'AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part A', 'timeFrame': 'On Day -1 at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose. on Days 1 and 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose.', 'description': 'Serial blood samples for the determination of the PK for atorvastatin metabolites on Day -1 was collected at immediately pre-morning dose=pre-breakfast (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14 and 24 hours post-morning dose (24 hour sample Day -1 = 0 hour sample Day 1). Serial blood samples for the determination of the PK for atorvastatin metabolites on Days 1 and 14 will be collected at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hour post-morning dose (no 48h sample on Day 1).'}, {'measure': 'AUC (0-24) of Atorvastatin Metabolite (2-Hydroxyatorvastatin)- Part B (Pooled Treatment Arm)', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16).'}, {'measure': 'Trough Concentration of Atorvastatin Metabolite (2-Hydroxyatorvastatin)', 'timeFrame': 'On Days -1 and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose', 'description': 'For co-dosing arms, serial blood samples for the determination of the PK of atorvastatin metabolites were supposed to collected on Day -1 and for atorvastatin metabolites on Days 1 and 14. Blood samples for PK were supposed to collected on Days -1 (co-dosing arms only) and 1 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, and 24 hours post-morning dose. Blood samples for PK were supposed to collected on Day 14 at immediately pre-morning dose (time 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 14, 24 and 48 hours post-morning dose (48 hour PK sample was collected on Day 16). However no data was collected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacodynamics', 'Lipids', 'Dyslipidemia', 'Safety', 'GSK1292263', 'Ezetimibe', 'Statin', 'Pharmacokinetics', 'Tolerability', 'Atorvastatin'], 'conditions': ['Dyslipidaemias', 'Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'This study investigates the safety, pharmacokinetics and effects of GSK1292263 when taken alone or when co-dosed with atorvastatin to subjects with dyslipidemia.', 'detailedDescription': 'This compound has been studied in healthy subjects and subjects with type II diabetes and is now being studied in subjects with dyslipidemia. Because many patients with dyslipidemia are on statins, it is important to study how GSK1292263 behaves when taken with a potent statin, atorvastatin. The cholesterol lowering drug, ezetimibe, is included for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult males and females of non-child-bearing-potential, aged 18-75 years who is capable of giving informed consent.\n* A female subject is eligible to participate if she is of:\n\n * Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. In questionable cases, a blood sample with simultaneous follicle stimulating hormone (FSH) \\> 40 MlU/ml and estradiol \\<40 pg/ml (\\<140 pmol/L) is confirmatory in the absence of a clear post-menopausal history.\n * Females on hormone replacement therapy (HRT) must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study.\n* Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until seven days following the last dose.\n* Body weight \\> 50 kg (110 pounds) and body mass index (BMI) between 19.0 and 39.0 (inclusive).\n* Part A: (i) Subjects who are on 80mg or 40mg atorvastatin for \\>= 4 weeks and are tolerating the drug well, or (ii) Subjects not on lipid-modifying therapy who have a fasting low density lipoprotein cholesterol (LDLc) \\>= 130mg/dL.\n* In Part B at Screening: Subjects who are on statins or Vytorin treatment for \\>= 4 weeks.\n* Part B at the end of the 4 week washout: Subjects who have a fasting LDL cholesterol of \\>=120mg/dL and \\<=180mg/dL and fasting triglycerides of \\>=100mg/dL and \\<=400mg/dL.\n* Part B at the end of the 4 week run-in on atorvastatin: Subjects who are tolerating well atorvastatin 10mg or 80mg (as determined by the Investigator).\n* Part B: Subjects must be willing to discontinue statins or Vytorin for the duration of the study.\n* Liver enzymes, AST and ALT \\< 2x upper limit of normal (ULN); alkaline phosphatase and bilirubin =\\< 1.5xULN (isolated bilirubin \\>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\<35%). Subjects with Gilbert's syndrome are allowed to participate in the study.\n* Average QTcB or QTcF \\< 450msec; or QTc \\< 480msec in subjects with right bundle branch block.\n\nExclusion Criteria:\n\n* A medical history of the following:\n\n * Clinical or angiographic cardiovascular disease, including history or current evidence of coronary heart disease, heart failure, cerebrovascular disease (including stroke and transient ischemic attack \\[mini-stroke\\]), peripheral vascular disease. Subjects pending diagnostic procedures for any of those conditions at the time of screening will not be eligible for participation.\n * Homozygous familial hypercholesterolemia or family history of familial hypercholesterolemia (Part B only). Note: Subjects with heterozygous familial hypercholesterolemia on 80mg atorvastatin who are tolerating this drug well and fulfill the other eligibility criteria may participate in Part A only.\n * History of recurrent or unexplained muscle aches (e.g., fibromyalgia), myopathy or myositis, whether or not it is related to treatment with statins or other lipid modifying drugs.\n * Renal impairment as defined by a calculated glomerular filtration rate \\< 60 mL/min\n * History of diabetes mellitus, or history of post-prandial and/or random blood glucose \\> 200 mg/dl or fasting glucose \\> 125 mg/dL or currently taking diabetes medications to manage fasting glucose levels (e.g., thiazolidinediones, sulfonylureas, insulin, metformin).\n * History of pancreatitis within 10 years of screening.\n * Any concurrent serious illness (e.g., severe chronic obstructive pulmonary disease, sleep apnea, history of malignancy other than skin cancer within 5 years of initial diagnosis or with evidence of recurrence) that may interfere with a subject from completing the study.\n * Current or chronic history of liver disease, or known hepatic or biliary abnormalities.\n * Active peptic ulcer disease and/or history of peptic ulcer disease or gastrointestinal bleeding within 12 months prior to screening.\n * History of kidney stones within 10 years of screening.\n * History of uncorrected thyroid dysfunction or an abnormal thyroid function test assessed by thyroid stimulating hormone (TSH) at Screening. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 3 months prior to screening and who have a screening TSH within the normal range may participate.)\n * Symptomatic cholelithiasis or obstructive or inflammatory gallbladder disease within 3 months prior to screening.\n * Gastrointestinal disease that could affect fat or bile acid absorption, or the pharmacokinetics or pharmacodynamics of the study drugs, including inflammatory bowel disease, chronic diarrhea, Crohn's disease or malabsorption syndromes within the past year.\n * Gastrointestinal surgery that may affect the pharmacokinetics or pharmacodynamics of the study drugs.\n\nNote: Subjects may be enrolled in the study if they have had a cholecystectomy three or more months before the time of screening and are stable and asymptomatic.\n\n* Subjects taking ezetimibe monotherapy, fibrates, bile acid binding resins, nicotinic acid or fat absorption inhibitors are not eligible for Parts A and B.\n* For females a hemoglobin \\< 11.5g/dL, and for males a hemoglobin \\< 12.5g/dL.\n* Current inadequately controlled hypertension (blood pressure \\>= 160mmHg systolic or \\>= 100mmHg diastolic at screening). If blood pressure medication is changed as a result of screening, blood pressure will be re-measured after 6 weeks and must again meet these criteria.\n* Significant electrocardiogram (ECG) abnormalities, defined as follows:\n\nHeart Rate \\< 50 and \\>100bpm PR Interval \\<120 and \\> 220ms QRS duration \\< 70 and \\>120ms QTC Interval (Bazett) \\> 450ms Or, has clinically significant rhythm abnormalities identified during 24-hour screening Holter assessment. Subjects with left bundle branch block are excluded from the study. Subjects with partial right bundle branch block may be considered for inclusion following consultation with the GlaxoSmithKline (GSK) Medical Monitor. Subjects with Wolf-Parkinson-White (WPW) syndrome are excluded from the study.\n\n* Creatinine phosphokinase (CPK) \\>= 2x ULN at screening.\n* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.\n* A positive test for HIV antibody.\n* The subject has a positive pre-study drug-of-abuse screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.\n* History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \\>14 drinks/week for men or \\>7 drinks/week for women. One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.\n* Subjects will be excluded if they require treatment with systemic corticosteroids.\n* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to dosing.\n* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.\n* History of sensitivity or untoward reaction to the study medications (GSK1292263, atorvastatin or ezetimibe), or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.\n* History of intolerance to statins.\n* Any change in concomitant medication (including multivitamins, herbal remedies, dietary supplements, and over-the-counter medication) within six weeks prior to screening that is not approved by GSK.\n* On a diet that may affect study outcomes, or any change in diet, exercise habits or smoking status within six weeks prior to screening or planned change during study (e.g., new exercise program) other than that in the dietary instructions in the Study Procedures Manual.\n* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.\n* Where participation in study would result in donation of blood in excess of approximately 500mL within a 56 day period.\n* Subject is mentally or legally incapacitated.\n* Unwillingness or inability to follow the procedures outlined in the protocol.\n* Pregnant females as determined by positive urine hCG test at screening or prior to dosing.\n* Lactating females.\n* History of sensitivity to heparin or heparin-induced thrombocytopenia.\n* Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.\n* Unwilling to abstain from caffeine-or xanthine-containing products from Day -2 until Day 15.\n* Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study."}, 'identificationModule': {'nctId': 'NCT01218204', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin', 'orgStudyIdInfo': {'id': '113779'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Part A Run-in', 'description': 'Subjects on stable 40mg atorvastatin \\> 4 weeks may raise their dose to 80mg for 2 weeks in order to qualify for Part A.', 'interventionNames': ['Drug: 80mg atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Co-Dosing 800mg GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 800mg GSK1292263']}, {'type': 'OTHER', 'label': 'Part B Washout', 'description': 'Washout for 4 weeks', 'interventionNames': ['Other: Washout']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B Run-in 10mg atorvastatin', 'description': 'Dosing for 4 weeks', 'interventionNames': ['Drug: 10mg atorvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Part B Run-in 80mg atorvastatin', 'description': 'Dosing for 4 weeks', 'interventionNames': ['Drug: 80mg atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Co-Dosing 10mg atorvastatin + 100mg GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 10mg atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Co-Dosing 10mg atorvastatin + 300mg GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 300mg GSK1292263']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Co-Dosing 10mg atorvastatin + 800mg GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 10mg atorvastatin', 'Drug: 800mg GSK1292263']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Co-Dosing 10mg atorvastatin + 10mg ezetimibe', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 10mg atorvastatin', 'Drug: 10mg ezetimibe']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dosing 100mg GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 100mg GSK1292263']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dosing 300mg GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 300mg GSK1292263']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dosing 800mg GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 800mg GSK1292263']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dosing Placebo GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: GSK1292263 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Co-Dosing 80mg atorvastatin + 800mg GSK1292263', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 80mg atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Co-dosing 80mg atorvastatin + Placebo (GSK1292263)', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: GSK1292263 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Co-Dosing 10mg atorvastatin + Placebo (GSK1292263)', 'description': 'Dosing for 14 days', 'interventionNames': ['Drug: 10mg atorvastatin']}], 'interventions': [{'name': '10mg atorvastatin', 'type': 'DRUG', 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