Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-04-21 @ 5:22 PM
Study NCT ID:
NCT02634151
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2015-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111024', 'term': 'gemcabene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@neurobopharma.com', 'phone': '+1 (857) 702-9600', 'title': 'Vice President Clinical Operations', 'organization': 'NeuroBo Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to end of study (Up to 113 days)', 'description': 'One participant received both treatments and is summarized under planned treatment (placebo) group for efficacy analysis and active treatment group (Gemcabene 600 mg) for safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 33, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 24, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Retinal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Immunology test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Red blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'White blood cells urine positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Joint crepitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Albuminuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Urine abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Nasal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in LDL-C at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.03', 'spread': '3.234', 'groupId': 'OG000'}, {'value': '-4.98', 'spread': '3.330', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.05', 'ciLowerLimit': '-18.81', 'ciUpperLimit': '-3.29', 'groupDescription': 'A 2-sided test with a significance level of 0.05 was used for the comparison.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by Last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C by Statin Intensity Stratum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Moderate intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.58', 'spread': '4.739', 'groupId': 'OG000'}, {'value': '-8.94', 'spread': '4.766', 'groupId': 'OG001'}]}]}, {'title': 'High intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.05', 'spread': '4.732', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '4.943', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.80', 'ciLowerLimit': '-24.35', 'ciUpperLimit': '0.75', 'groupDescription': 'High-Intensity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0398', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.64', 'ciLowerLimit': '-20.77', 'ciUpperLimit': '-0.51', 'groupDescription': 'Moderate Intensity.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group and baseline diabetes status are included as factors, and the outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The intensity of statin therapy was determined based on the statin dose.Participants were categorized as high intensity \\& moderate intensity based on their statin doses.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, Number analyzed signifies those participants who were evaluable in each category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-25.69', 'spread': '3.731', 'groupId': 'OG000'}, {'value': '-15.60', 'spread': '3.842', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-20.72', 'spread': '3.958', 'groupId': 'OG000'}, {'value': '-11.32', 'spread': '4.076', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-17.97', 'spread': '4.172', 'groupId': 'OG000'}, {'value': '-18.86', 'spread': '4.296', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-20.40', 'spread': '4.059', 'groupId': 'OG000'}, {'value': '-7.77', 'spread': '4.180', 'groupId': 'OG001'}]}]}, {'title': 'Average of week 8 and 12', 'categories': [{'measurements': [{'value': '-19.19', 'spread': '3.717', 'groupId': 'OG000'}, {'value': '-13.32', 'spread': '3.827', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0275', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.09', 'ciLowerLimit': '-19.04', 'ciUpperLimit': '-1.14', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0524', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.40', 'ciLowerLimit': '-18.90', 'ciUpperLimit': '0.10', 'groupDescription': 'Week 4.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.8602', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '-9.12', 'ciUpperLimit': '10.90', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0115', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.63', 'ciLowerLimit': '-22.37', 'ciUpperLimit': '-2.89', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.1945', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.87', 'ciLowerLimit': '-14.79', 'ciUpperLimit': '3.05', 'groupDescription': 'Average of week 8 and 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.15', 'spread': '2.921', 'groupId': 'OG000'}, {'value': '-9.27', 'spread': '3.008', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0991', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.88', 'ciLowerLimit': '-12.89', 'ciUpperLimit': '1.13', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, average of weeks 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-17.60', 'spread': '2.397', 'groupId': 'OG000'}, {'value': '-10.01', 'spread': '2.461', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-13.27', 'spread': '2.664', 'groupId': 'OG000'}, {'value': '-3.71', 'spread': '2.735', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-12.35', 'spread': '2.831', 'groupId': 'OG000'}, {'value': '-11.41', 'spread': '2.907', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-14.48', 'spread': '2.860', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '2.936', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.58', 'ciLowerLimit': '-13.32', 'ciUpperLimit': '-1.84', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0037', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.56', 'ciLowerLimit': '-15.94', 'ciUpperLimit': '-3.18', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.7839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-7.72', 'ciUpperLimit': '5.84', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.69', 'ciLowerLimit': '-17.53', 'ciUpperLimit': '-3.84', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-29.21', 'spread': '4.088', 'groupId': 'OG000'}, {'value': '-16.55', 'spread': '4.197', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-21.88', 'spread': '4.318', 'groupId': 'OG000'}, {'value': '-6.33', 'spread': '4.433', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-19.45', 'spread': '4.551', 'groupId': 'OG000'}, {'value': '-18.86', 'spread': '4.673', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-23.21', 'spread': '4.451', 'groupId': 'OG000'}, {'value': '-6.62', 'spread': '4.570', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.66', 'ciLowerLimit': '-22.45', 'ciUpperLimit': '-2.88', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.55', 'ciLowerLimit': '-25.88', 'ciUpperLimit': '-5.21', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.9147', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-11.48', 'ciUpperLimit': '10.31', 'pValueComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.59', 'ciLowerLimit': '-27.24', 'ciUpperLimit': '-5.93', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-14.10', 'spread': '1.923', 'groupId': 'OG000'}, {'value': '-7.97', 'spread': '1.989', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-10.35', 'spread': '2.136', 'groupId': 'OG000'}, {'value': '-2.62', 'spread': '2.209', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-8.77', 'spread': '2.236', 'groupId': 'OG000'}, {'value': '-8.88', 'spread': '2.313', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-9.79', 'spread': '2.161', 'groupId': 'OG000'}, {'value': '-2.90', 'spread': '2.235', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.13', 'ciLowerLimit': '-10.77', 'ciUpperLimit': '-1.50', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.73', 'ciLowerLimit': '-12.89', 'ciUpperLimit': '-2.58', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.9653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-5.27', 'ciUpperLimit': '5.51', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0101', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.89', 'ciLowerLimit': '-12.10', 'ciUpperLimit': '-1.68', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-30.47', 'spread': '4.331', 'groupId': 'OG000'}, {'value': '-17.73', 'spread': '4.479', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-22.37', 'spread': '4.514', 'groupId': 'OG000'}, {'value': '-6.08', 'spread': '4.669', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-18.10', 'spread': '4.741', 'groupId': 'OG000'}, {'value': '-19.68', 'spread': '4.903', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-20.90', 'spread': '4.500', 'groupId': 'OG000'}, {'value': '-6.92', 'spread': '4.654', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0173', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.74', 'ciLowerLimit': '-23.19', 'ciUpperLimit': '-2.30', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.29', 'ciLowerLimit': '-27.17', 'ciUpperLimit': '-5.40', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.7846', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '-9.85', 'ciUpperLimit': '13.01', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0121', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.98', 'ciLowerLimit': '-24.83', 'ciUpperLimit': '-3.13', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in TG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-10.58', 'spread': '4.251', 'groupId': 'OG000'}, {'value': '2.64', 'spread': '4.342', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-6.28', 'spread': '4.706', 'groupId': 'OG000'}, {'value': '17.31', 'spread': '4.807', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-4.94', 'spread': '3.743', 'groupId': 'OG000'}, {'value': '1.76', 'spread': '3.823', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-8.22', 'spread': '5.245', 'groupId': 'OG000'}, {'value': '7.42', 'spread': '5.356', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.32', 'ciLowerLimit': '-23.32', 'ciUpperLimit': '-3.12', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.60', 'ciLowerLimit': '-34.78', 'ciUpperLimit': '-12.42', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.1376', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.71', 'ciLowerLimit': '-15.60', 'ciUpperLimit': '2.18', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0144', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.64', 'ciLowerLimit': '-28.10', 'ciUpperLimit': '-3.18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-18.88', 'spread': '6.322', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '6.457', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-6.08', 'spread': '7.132', 'groupId': 'OG000'}, {'value': '27.56', 'spread': '7.284', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-8.17', 'spread': '5.238', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '5.350', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-15.94', 'spread': '10.194', 'groupId': 'OG000'}, {'value': '13.64', 'spread': '10.412', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.53', 'ciLowerLimit': '-34.55', 'ciUpperLimit': '-4.51', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.64', 'ciLowerLimit': '-50.58', 'ciUpperLimit': '-16.69', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.1873', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.33', 'ciLowerLimit': '-20.77', 'ciUpperLimit': '4.12', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0172', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.58', 'ciLowerLimit': '-53.80', 'ciUpperLimit': '-5.37', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in VLDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-10.55', 'spread': '4.104', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '4.192', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-6.63', 'spread': '4.632', 'groupId': 'OG000'}, {'value': '16.38', 'spread': '4.731', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-4.69', 'spread': '3.687', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '3.765', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-7.69', 'spread': '4.155', 'groupId': 'OG000'}, {'value': '3.94', 'spread': '4.243', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.52', 'ciLowerLimit': '-21.27', 'ciUpperLimit': '-1.77', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.01', 'ciLowerLimit': '-34.02', 'ciUpperLimit': '-12.01', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.1483', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.43', 'ciLowerLimit': '-15.19', 'ciUpperLimit': '2.33', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0214', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.63', 'ciLowerLimit': '-21.50', 'ciUpperLimit': '-1.76', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in VLDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-3.64', 'spread': '1.124', 'groupId': 'OG000'}, {'value': '-0.69', 'spread': '1.148', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.27', 'spread': '1.371', 'groupId': 'OG000'}, {'value': '5.02', 'spread': '1.400', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-1.56', 'spread': '1.034', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '1.056', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-2.89', 'spread': '1.279', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '1.306', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0308', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.95', 'ciLowerLimit': '-5.62', 'ciUpperLimit': '-0.28', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.30', 'ciLowerLimit': '-9.56', 'ciUpperLimit': '-3.04', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.58', 'ciLowerLimit': '-4.03', 'ciUpperLimit': '0.88', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.00', 'ciLowerLimit': '-7.04', 'ciUpperLimit': '-0.96', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-2.73', 'spread': '1.771', 'groupId': 'OG000'}, {'value': '-0.60', 'spread': '1.821', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.888', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '1.941', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2.34', 'spread': '2.112', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '2.171', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.86', 'spread': '2.129', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '2.189', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.13', 'ciLowerLimit': '-6.36', 'ciUpperLimit': '2.09', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.'}, {'pValue': '0.2932', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.40', 'ciLowerLimit': '-6.91', 'ciUpperLimit': '2.11', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.4383', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '-3.06', 'ciUpperLimit': '7.02', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2814', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.78', 'ciLowerLimit': '-2.31', 'ciUpperLimit': '7.86', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.964', 'groupId': 'OG000'}, {'value': '-0.41', 'spread': '0.991', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.48', 'spread': '1.004', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '1.033', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.35', 'spread': '1.099', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '1.130', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.22', 'spread': '1.182', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '1.216', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.92', 'ciLowerLimit': '-3.23', 'ciUpperLimit': '1.38', 'groupDescription': 'Week 2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.3529', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-3.53', 'ciUpperLimit': '1.27', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.3522', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '-1.39', 'ciUpperLimit': '3.86', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2635', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '4.42', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving LDL-C Reduction of ≥10%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0464', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.23', 'ciLowerLimit': '1.01', 'ciUpperLimit': '4.93', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.5278', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.58', 'ciUpperLimit': '2.92', 'groupDescription': 'Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0359', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.36', 'ciLowerLimit': '1.06', 'ciUpperLimit': '5.27', 'groupDescription': 'Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 8 and 12', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving LDL-C Reduction of ≥15%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0268', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.50', 'ciLowerLimit': '1.11', 'ciUpperLimit': '5.61', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2755', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.55', 'ciLowerLimit': '0.70', 'ciUpperLimit': '3.41', 'groupDescription': 'Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.74', 'ciLowerLimit': '2.05', 'ciUpperLimit': '10.94', 'groupDescription': 'Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 8 and 12', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving LDL-C Reduction of ≥20%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.26', 'ciLowerLimit': '1.36', 'ciUpperLimit': '7.80', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.4002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.62', 'ciUpperLimit': '3.35', 'groupDescription': 'Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0142', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.09', 'ciLowerLimit': '1.25', 'ciUpperLimit': '7.59', 'groupDescription': 'Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8 and 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0115', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.70', 'ciLowerLimit': '1.34', 'ciUpperLimit': '10.20', 'groupDescription': 'Week 4', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.7566', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.48', 'ciUpperLimit': '2.75', 'groupDescription': 'Week 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0298', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.96', 'ciLowerLimit': '1.11', 'ciUpperLimit': '7.88', 'groupDescription': 'Week 12', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 8 and 12', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-8.7', 'spread': '2.81', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-9.8', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '-5.5', 'spread': '2.60', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-10.5', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.4', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '-3.7', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.1666', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.3', 'ciLowerLimit': '-10.4', 'ciUpperLimit': '1.8', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.5', 'ciLowerLimit': '-18.2', 'ciUpperLimit': '-4.8', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Apolipoprotein B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-10.6', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-11.1', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '2.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-12.0', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.7', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '-4.1', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-10.1', 'ciUpperLimit': '2.6', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.6', 'ciLowerLimit': '-18.5', 'ciUpperLimit': '-4.7', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein A-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.51', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6832', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-4.2', 'ciUpperLimit': '2.8', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.6740', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '4.5', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.3379', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '5.7', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Apolipoprotein A-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.36', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.45', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '6.9', 'spread': '2.50', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7753', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '4.4', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.5472', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '7.4', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2406', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '9.6', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein A-II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.54', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.7', 'spread': '1.80', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '3.8', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0199', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '0.8', 'ciUpperLimit': '9.6', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0369', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'ciLowerLimit': '0.3', 'ciUpperLimit': '8.9', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Apolipoprotein A-II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '1.4', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0243', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.9', 'ciLowerLimit': '0.3', 'ciUpperLimit': '3.5', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0388', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '0.1', 'ciUpperLimit': '3.2', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein C-II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '20.0', 'spread': '5.34', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '5.46', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '30.7', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '7.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '27.3', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '7.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2799', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.0', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '19.6', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.8', 'ciLowerLimit': '10.2', 'ciUpperLimit': '43.3', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.1', 'ciLowerLimit': '3.3', 'ciUpperLimit': '36.9', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Apolipoprotein C-II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.1', 'ciUpperLimit': '1.0', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.7', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0095', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '0.2', 'ciUpperLimit': '1.5', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein C-III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '3.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '3.5', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '9.7', 'spread': '4.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.2', 'ciLowerLimit': '-20.8', 'ciUpperLimit': '-3.6', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.9665', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '8.6', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.2', 'ciLowerLimit': '-16.4', 'ciUpperLimit': '4.1', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Apolipoprotein C-III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '-0.4', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.9064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '0.8', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2505', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.4', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Apolipoprotein E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-6.7', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-7.8', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '3.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.8', 'ciLowerLimit': '-22.6', 'ciUpperLimit': '-9.0', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0406', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-14.0', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.3', 'ciLowerLimit': '-22.8', 'ciUpperLimit': '-7.8', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Apolipoprotein E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0771', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.0', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '-0.3', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Lipoprotein(a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.5', 'spread': '4.61', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '4.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '3.9', 'spread': '3.94', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '4.2', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '5.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '19.6', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.0948', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.0', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '17.3', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.5113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.1', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '16.4', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipoprotein(a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '4.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2.1', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '3.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '2.1', 'spread': '4.00', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '4.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7276', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.7', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '11.1', 'groupDescription': 'Week 4', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.2218', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '12.2', 'groupDescription': 'Week 8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}, {'pValue': '0.9420', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '9.8', 'groupDescription': 'Week 12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 12', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in High-sensitivity C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.33', 'spread': '64.525', 'groupId': 'OG000'}, {'value': '24.76', 'spread': '66.946', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.57', 'ciLowerLimit': '-122.98', 'ciUpperLimit': '188.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High-sensitivity C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '0.44', 'spread': '0.513', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1648', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.84', 'ciLowerLimit': '-2.03', 'ciUpperLimit': '0.35', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Fibrinogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '47.59', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '48.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4701', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.5', 'ciLowerLimit': '-72.1', 'ciUpperLimit': '155.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fibrinogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '13.69', 'groupId': 'OG000'}, {'value': '41.4', 'spread': '14.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0517', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.4', 'ciLowerLimit': '-65.1', 'ciUpperLimit': '0.2', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum Amyloid A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '69.71', 'groupId': 'OG000'}, {'value': '44.1', 'spread': '71.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-177.8', 'ciUpperLimit': '158.8', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Amyloid A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3864', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.0', 'ciLowerLimit': '-10.0', 'ciUpperLimit': '3.9', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Adiponectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '4.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.2', 'ciLowerLimit': '2.5', 'ciUpperLimit': '22.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Adiponectin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0510', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.0', 'ciUpperLimit': '1.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Randomized treatment group, baseline statin intensity, \\& diabetes status are included as factors, \\& outcome at baseline is included as a covariate.', 'nonInferiorityComment': 'A 2-sided test with a significance level of 0.05 was used for the comparison.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF. Here, overall number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Framingham Risk Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.051', 'spread': '4.1599', 'groupId': 'OG000'}, {'value': '-0.850', 'spread': '4.9889', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "Framingham Risk Score was an estimate of a participant's 10-year risk of developing cardiovascular disease which was computed using sex-specific algorithms based on total point score (range less than negative 3 \\[best\\] to greater than or equal to 14 \\[worst\\] for men; less than or equal to negative 2 \\[best\\] and greater than or equal to 17 \\[worst\\] for women) : which was derived of participant's age, systolic blood pressure , smoking status, TC, HDL-C, treatment for hypertension, and diabetes status. Reported score is a percentage. Change from baseline calculated as mean at week 12 minus mean at baseline. Negative scores indicate less risk of developing cardiovascular disease.", 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Population. Missing values were imputed by LOCF.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants who had heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease (ASCVD) and were on a statin therapy were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 mg of Gemcabene orally, once daily for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.7', 'spread': '9.30', 'groupId': 'BG000'}, {'value': '59.0', 'spread': '9.67', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '9.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Low-density lipoprotein cholesterol (LDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '133.83', 'spread': '24.107', 'groupId': 'BG000'}, {'value': '126.49', 'spread': '28.101', 'groupId': 'BG001'}, {'value': '130.20', 'spread': '26.294', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milligram per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Non-high-density lipoprotein cholesterol (non-HDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '162.17', 'spread': '29.664', 'groupId': 'BG000'}, {'value': '154.31', 'spread': '32.796', 'groupId': 'BG001'}, {'value': '158.28', 'spread': '31.353', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total Cholesterol (TC)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '216.68', 'spread': '28.643', 'groupId': 'BG000'}, {'value': '206.16', 'spread': '31.848', 'groupId': 'BG001'}, {'value': '211.47', 'spread': '30.586', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides (TG)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '141.57', 'spread': '60.696', 'groupId': 'BG000'}, {'value': '138.80', 'spread': '65.088', 'groupId': 'BG001'}, {'value': '140.20', 'spread': '62.621', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-density lipoprotein cholesterol (HDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.51', 'spread': '14.594', 'groupId': 'BG000'}, {'value': '51.86', 'spread': '13.097', 'groupId': 'BG001'}, {'value': '53.20', 'spread': '13.870', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Very low-density lipoprotein cholesterol (VLDL-C)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.34', 'spread': '12.114', 'groupId': 'BG000'}, {'value': '27.82', 'spread': '13.048', 'groupId': 'BG001'}, {'value': '28.08', 'spread': '12.527', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL-C by Statin intensity stratum', 'classes': [{'title': 'Moderate-intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '128.91', 'spread': '18.742', 'groupId': 'BG000'}, {'value': '124.54', 'spread': '28.104', 'groupId': 'BG001'}, {'value': '126.76', 'spread': '23.681', 'groupId': 'BG002'}]}]}, {'title': 'High-intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '139.34', 'spread': '28.356', 'groupId': 'BG000'}, {'value': '128.60', 'spread': '28.521', 'groupId': 'BG001'}, {'value': '133.97', 'spread': '28.665', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The intensity of statin therapy was determined based on the statin dose.Participants were categorized as high intensity \\& moderate intensity based on their statin doses.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS Population.Here, number analyzed signifies those participants who were evaluable in each category.'}, {'title': 'Apolipoprotein B (ApoB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '108.0', 'spread': '19.61', 'groupId': 'BG000'}, {'value': '100.1', 'spread': '22.22', 'groupId': 'BG001'}, {'value': '104.1', 'spread': '21.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein A-I (ApoA-I)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '155.3', 'spread': '22.14', 'groupId': 'BG000'}, {'value': '148.8', 'spread': '25.45', 'groupId': 'BG001'}, {'value': '152.1', 'spread': '23.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein A-II (ApoA-II)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '36.9', 'spread': '5.38', 'groupId': 'BG000'}, {'value': '36.0', 'spread': '5.86', 'groupId': 'BG001'}, {'value': '36.5', 'spread': '5.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'FAS Population. Here, number analyzed signifies participants with available data.'}, {'title': 'Apolipoprotein C-II (ApoC-II)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.45', 'groupId': 'BG000'}, {'value': '5.5', 'spread': '2.65', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '2.54', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein C-III (ApoC-III)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '3.40', 'groupId': 'BG000'}, {'value': '10.7', 'spread': '3.69', 'groupId': 'BG001'}, {'value': '10.8', 'spread': '3.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Apolipoprotein E (ApoE)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.97', 'groupId': 'BG000'}, {'value': '4.2', 'spread': '1.08', 'groupId': 'BG001'}, {'value': '4.3', 'spread': '1.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-sensitivity C-reactive protein (hsCRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.93', 'spread': '2.792', 'groupId': 'BG000'}, {'value': '3.91', 'spread': '4.779', 'groupId': 'BG001'}, {'value': '3.42', 'spread': '3.916', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milligram per Liter (mg/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fibrinogen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '453.5', 'spread': '113.26', 'groupId': 'BG000'}, {'value': '460.7', 'spread': '92.22', 'groupId': 'BG001'}, {'value': '457.1', 'spread': '102.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lipoprotein(a)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '104.4', 'spread': '123.23', 'groupId': 'BG000'}, {'value': '113.8', 'spread': '102.59', 'groupId': 'BG001'}, {'value': '109.1', 'spread': '113.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Nanomole per liter (nmol/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Adiponectin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '4.90', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '3.98', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '4.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Microgram per milliliter (μg/mL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum amyloid A', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '3.20', 'groupId': 'BG000'}, {'value': '8.6', 'spread': '11.01', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '816', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Framingham Risk Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18.109', 'spread': '13.8630', 'groupId': 'BG000'}, {'value': '15.381', 'spread': '11.4957', 'groupId': 'BG001'}, {'value': '16.758', 'spread': '12.7583', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Framingham Risk Score was an estimate of a participant's 10-year risk of developing cardiovascular disease which was computed using sex-specific algorithms based on total point score (range less than negative 3 \\[best\\] to greater than or equal to 14 \\[worst\\] for men; less than or equal to negative 2 \\[best\\] and greater than or equal to 17 \\[worst\\] for women) which was derived of participant's age, systolic blood pressure, smoking status, TC, HDL-C, treatment for hypertension, and diabetes status.Reported score is a percentage.", 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis Set (FAS): All randomized participants who received at least 1 dose of the study drug and had at least 1 post-baseline efficacy assessment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-10', 'size': 1163497, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-14T08:09', 'hasProtocol': False}, {'date': '2016-10-05', 'size': 2730573, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-03T06:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-03', 'studyFirstSubmitDate': '2015-12-11', 'resultsFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2015-12-15', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-03', 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in LDL-C at Week 12', 'timeFrame': 'Baseline, Week 12'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in LDL-C by Statin Intensity Stratum', 'timeFrame': 'Baseline, Week 12', 'description': 'The intensity of statin therapy was determined based on the statin dose.Participants were categorized as high intensity \\& moderate intensity based on their statin doses.'}, {'measure': 'Change From Baseline in LDL-C', 'timeFrame': 'Baseline, Weeks 2, 4, 8, 12 and average of weeks 8 and 12'}, {'measure': 'Percent Change From Baseline in LDL-C', 'timeFrame': 'Baseline, average of weeks 8 and 12'}, {'measure': 'Percent Change From Baseline in Non-HDL-C', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Change From Baseline in Non-HDL-C', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in TC', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Change From Baseline in TC', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in TG', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Change From Baseline in TG', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in VLDL-C', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Change From Baseline in VLDL-C', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in HDL-C', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Change From Baseline in HDL-C', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and 12'}, {'measure': 'Number of Participants Achieving LDL-C Reduction of ≥10%', 'timeFrame': 'Weeks 4, 8 and 12'}, {'measure': 'Number of Participants Achieving LDL-C Reduction of ≥15%', 'timeFrame': 'Weeks 4, 8 and 12'}, {'measure': 'Number of Participants Achieving LDL-C Reduction of ≥20%', 'timeFrame': 'Weeks 4, 8 and 12'}, {'measure': 'Number of Participants Achieving an LDL-C Value <100 mg/dL (2.59 mmol/L)', 'timeFrame': 'Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein B', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Change From Baseline in Apolipoprotein B', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein A-I', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Change From Baseline in Apolipoprotein A-I', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein A-II', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Change From Baseline in Apolipoprotein A-II', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein C-II', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Change From Baseline in Apolipoprotein C-II', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein C-III', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Change From Baseline in Apolipoprotein C-III', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in Apolipoprotein E', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Change From Baseline in Apolipoprotein E', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in Lipoprotein(a)', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Change From Baseline in Lipoprotein(a)', 'timeFrame': 'Baseline, Weeks 4, 8 and 12'}, {'measure': 'Percent Change From Baseline in High-sensitivity C-reactive Protein', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in High-sensitivity C-reactive Protein', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Percent Change From Baseline in Fibrinogen', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in Fibrinogen', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Percent Change From Baseline in Serum Amyloid A', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in Serum Amyloid A', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Percent Change From Baseline in Adiponectin', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in Adiponectin', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in Framingham Risk Score', 'timeFrame': 'Baseline, Week 12', 'description': "Framingham Risk Score was an estimate of a participant's 10-year risk of developing cardiovascular disease which was computed using sex-specific algorithms based on total point score (range less than negative 3 \\[best\\] to greater than or equal to 14 \\[worst\\] for men; less than or equal to negative 2 \\[best\\] and greater than or equal to 17 \\[worst\\] for women) : which was derived of participant's age, systolic blood pressure , smoking status, TC, HDL-C, treatment for hypertension, and diabetes status. Reported score is a percentage. Change from baseline calculated as mean at week 12 minus mean at baseline. Negative scores indicate less risk of developing cardiovascular disease."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LDL-C', 'Lipid Regulator'], 'conditions': ['Hypercholesteremia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the efficacy, safety, and tolerability of multiple doses of gemcabene 600 mg QD compared to placebo in patients with hypercholesterolemia not adequately controlled on high-intensity or moderate-intensity stable statin therapy. Patients with HeFH, ASCVD, or otherwise uncontrolled, may be included with baseline LDL-C value ≥ 100 mg/dL. Subjects were randomized 1:1 to gemcabene 600 mg once daily (QD) or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "1. Provision of written and signed informed consent (by subject or legal guardian) prior to any study-specific procedures;\n2. Male or female (neither pregnant or lactating) ≥ 18 years of age at the time of consent;\n3. Currently on a stable, low-fat, low-cholesterol diet in combination with allowed statin doses as described in Table 1, with or without ezetimibe 10 mg QD for at least 12 weeks prior to the Screening Visit;\n4. Fasting LDL-C value ≥ 100 mg/dL (2.59 mmol/L) at the Screening Visit;\n5. Physical examination, including vital signs, that is within normal limits or clinically acceptable to the Investigator;\n6. Weight ≥ 50 kg; with a body mass index (BMI) ≤ 45 kg/m2\n7. Subjects with Type 2 diabetes who take anti-hyperglycemic agents must be on a stable regimen for at least 3 months, with no planned changes in medications for the study duration.\n\nExclusion Criteria\n\n1. Abnormal liver function test at the Pre-Screening or Screening Visit (AST or ALT) \\> 2x ULN (upper limit of normal), total bilirubin \\> 1.5x ULN, or alkaline phosphate \\> 2x ULN based on appropriate age and gender normal values. Subjects with bilirubin \\> 1.5x ULN and a history of Gilbert's syndrome may be included; reflexive direct bilirubin testing will be used to confirm Gilbert's syndrome;\n2. Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to the Child-Pugh classification;\n3. Active liver disease (e.g. cirrhosis, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune hepatitis, liver failure, liver cancer), history of liver transplant, known diagnosis of HIV or AIDS;\n4. Triglyceride value ≥ 500 mg/dL at the Pre-Screening Visit or the Screening Visit;\n5. Moderate to severe renal insufficiency define as an estimated GFR \\< 60mL/min/1.73m (calculated using the Chronic Kidney Disease Epidemiology Collaboration equation) at the Pre-Screening Visit or Screening Visit;\n6. Abnormal urinalysis (proteinuria greater than trace or any male or non-menstruating female with greater than trace hematuria) confirmed by reflexive urine protein:creatinine ration testing;\n7. Uncontrolled thyroid disease; hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) below the lower limit of normal or \\> 1.5x ULN, respectively, based on results from the Pre-Screening Visit or the Screening Visit. If controlled, treatment should be stable for at least 3 months prior to Screening;\n8. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (hemoglobin A1c value \\> 8.5% based on results from the Pre-Screening or Screening Visit, or taking a thiazolidinedione (i.e. pioglitazone or rosiglitazone);\n9. New York Heart Association Class III or IV heart failure;\n10. Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or other major cardiovascular events resulting in hospitalization within 3 months of the Screening Visit. Subjects with adequately treated stable angina, per Investigator assessment, may be included;\n11. Uncontrolled cardiac arrhythmia or prolonged QT on the Screening Visit or Day 1 prior to dosing ECG (QTcF \\> 450 msec for men and \\> 470 msec for women) or known family history of prolonged QT or unexplained sudden cardiac death;\n12. Uncontrolled hypertension, defined as sitting systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg, and confirmed by repeat measurement;\n13. Currently receiving cancer treatments or, in the Investigator's opinion, at risk of relapse for recent cancer;\n14. Inadequate wash-out of a PCSK9 inhibitor (8 weeks prior to the Screening Visit), a fibrate lipid-regulating agent (6 weeks prior to the Screening Visit), niacins (4 weeks prior to the Screening Visit), or other lipid-regulating therapies such as bile acid sequestrants (4 weeks prior to the Screening Visit);\n15. Hypersensitivity to or a history of significant adverse reactions to any fibrate lipid-regulating agent;\n16. Use of any excluded medications or supplements (e.g. potent cytochrome P450 \\[CYP\\] 3A4 inhibitors as described in Appendix D;\n17. History of drug or alcohol abuse within the past year or inability to comply with protocol requirements, including subjects restrictions (see Section 5.6.3);\n18. Previously treated with gemcabene (CI-1027), participation in another clinical study of an investigational agent or device concurrently or within 1 month prior the Screening Visit, or use of an investigational agent within 1 month or 5 half-lives (if known), whichever is longer, prior to the Screening Visit;\n19. Any other finding which, in the opinion of the Investigator, would compromise the subject's safety or participation in the study."}, 'identificationModule': {'nctId': 'NCT02634151', 'acronym': 'ROYAL-1', 'briefTitle': 'A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins', 'organization': {'class': 'INDUSTRY', 'fullName': 'NeuroBo Pharmaceuticals Inc.'}, 'officialTitle': 'A 12-Week, Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Gemcabene in Subjects With Hypercholesterolemia Not Adequately Controlled on High-Intensity or Moderate-Intensity Stable Statin Therapy', 'orgStudyIdInfo': {'id': 'GEM-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants on stable statin therapy received matching placebo orally, once daily for 12 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Gemcabene 600 mg', 'description': 'Participants on stable statin therapy received 600 milligrams (mg) of Gemcabene orally, once daily for 12 weeks.', 'interventionNames': ['Drug: Gemcabene']}], 'interventions': [{'name': 'Gemcabene', 'type': 'DRUG', 'description': 'Two 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks.', 'armGroupLabels': ['Gemcabene 600 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Three placebo tablets administered orally once daily for 12 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Central Research Associates, Inc.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Westside Medical Associates of Los Angeles', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90057', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'facility': 'Atlantic Clinical Research Collaborative- Cardiology', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '33434', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Excel Medical Clinical Trials', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Health Awareness, Inc.', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research, Inc.', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Progressive Medical Research', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '33626', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Varkey Medical', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Premier Healthcare Research, LLC', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Institute for Clinical Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'L-MARC', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '12553', 'city': 'New Windsor', 'state': 'New York', 'country': 'United States', 'facility': 'Mid-Hudson Medical Research', 'geoPoint': {'lat': 41.47676, 'lon': -74.02375}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sterling Research Group, Ltd.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sentral Clinical Research Services', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Sterling Research Group, Ltd.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19446', 'city': 'Lansdale', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Green and Seidner Family Practice Associates', 'geoPoint': {'lat': 40.2415, 'lon': -75.28379}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Associates in Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diagnostics Research Grup', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Sugar Lakes Family Practice', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'National Research Institute', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NeuroBo Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}