Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-01-26 @ 10:46 AM
Study NCT ID:
NCT02991118
Status:
COMPLETED
Last Update Posted:
2020-04-27
First Post:
2016-12-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581236', 'term': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@esperion.com', 'phone': '1-833-377-7633', 'title': 'Medical Director', 'organization': 'Esperion Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'If the Principal Investigator plans to publish information from the study, a copy of the manuscript should be provided to the Sponsor for review before submission for publication or presentation. The Sponsor may request that that publication be withheld.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to Week 52', 'description': 'Treatment-emergent events, defined as those adverse events that began or worsened after the first dose of investigational medicinal product (IMP) until 30 days after the last dose of IMP, were collected and reported. The analysis was performed using the Safety Analysis Set, comprised of all randomized participants who received \\>=1 dose of IMP.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.', 'otherNumAtRisk': 257, 'deathsNumAtRisk': 257, 'otherNumAffected': 88, 'seriousNumAtRisk': 257, 'deathsNumAffected': 2, 'seriousNumAffected': 48}, {'id': 'EG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.', 'otherNumAtRisk': 522, 'deathsNumAtRisk': 522, 'otherNumAffected': 211, 'seriousNumAtRisk': 522, 'deathsNumAffected': 6, 'seriousNumAffected': 106}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastric antral vascular ectasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oesophageal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peritoneal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vascular stent occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urethral stricture post infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Brain contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gas poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Kidney rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Postoperative thoracic procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ejection fraction decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Periostitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neuroendocrine tumour of the lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyporeflexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Post stroke epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Perinephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Supportive care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Subclavian artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 522, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.35', 'spread': '1.446', 'groupId': 'OG000'}, {'value': '-15.07', 'spread': '1.073', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.42', 'ciLowerLimit': '-20.951', 'ciUpperLimit': '-13.896', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.800', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (atherosclerotic cardiovascular diseases \\[ASCVD\\] and heterozygous familial hypercholesterolemia \\[HeFH\\]) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 are imputed using multiple imputation method taking into account adherence to treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 24 in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.66', 'spread': '1.910', 'groupId': 'OG000'}, {'value': '-12.10', 'spread': '1.479', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.77', 'ciLowerLimit': '-19.504', 'ciUpperLimit': '-10.027', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.418', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 24 were imputed using multiple imputation method taking into account adherence to treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.28', 'spread': '1.351', 'groupId': 'OG000'}, {'value': '-10.75', 'spread': '0.952', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.03', 'ciLowerLimit': '-16.270', 'ciUpperLimit': '-9.794', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.652', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing non-HDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Total Cholesterol (TC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'spread': '1.010', 'groupId': 'OG000'}, {'value': '-9.94', 'spread': '0.688', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.20', 'ciLowerLimit': '-13.599', 'ciUpperLimit': '-8.801', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.224', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing TC data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.73', 'spread': '1.340', 'groupId': 'OG000'}, {'value': '-9.29', 'spread': '0.851', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.02', 'ciLowerLimit': '-16.130', 'ciUpperLimit': '-9.907', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.587', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing apo B data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: all randomized participants'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.366', 'groupId': 'OG000', 'lowerLimit': '-36.320', 'upperLimit': '35.241'}, {'value': '-18.699', 'groupId': 'OG001', 'lowerLimit': '-46.067', 'upperLimit': '23.864'}]}]}], 'analyses': [{'pValue': '<0.039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.733', 'ciLowerLimit': '-17.238', 'ciUpperLimit': '-0.434', 'estimateComment': 'The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '30.62', 'groupId': 'OG000'}, {'value': '-21.2', 'spread': '30.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '37.51', 'groupId': 'OG000'}, {'value': '-18.7', 'spread': '35.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 12 in Triglycerides (TGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '499', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.12', 'spread': '2.294', 'groupId': 'OG000'}, {'value': '11.01', 'spread': '2.312', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.134', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.89', 'ciLowerLimit': '-1.504', 'ciUpperLimit': '11.292', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.258', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the TG values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in TG was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 12 in HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '499', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.864', 'groupId': 'OG000'}, {'value': '-6.38', 'spread': '0.741', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.13', 'ciLowerLimit': '-8.369', 'ciUpperLimit': '-3.896', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.139', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 52 in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.97', 'spread': '1.830', 'groupId': 'OG000'}, {'value': '-13.24', 'spread': '1.412', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.27', 'ciLowerLimit': '-16.813', 'ciUpperLimit': '-7.722', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.314', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 24 in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '485', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.44', 'spread': '1.611', 'groupId': 'OG000'}, {'value': '-10.19', 'spread': '1.200', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.63', 'ciLowerLimit': '-16.580', 'ciUpperLimit': '-8.682', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.010', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 52 in Non-HDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.605', 'groupId': 'OG000'}, {'value': '-10.34', 'spread': '1.150', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.92', 'ciLowerLimit': '-13.803', 'ciUpperLimit': '-6.037', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.976', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 24 in TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '486', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.52', 'spread': '1.216', 'groupId': 'OG000'}, {'value': '-9.25', 'spread': '0.857', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.77', 'ciLowerLimit': '-13.698', 'ciUpperLimit': '-7.848', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.489', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 52 in TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.89', 'spread': '1.199', 'groupId': 'OG000'}, {'value': '-10.25', 'spread': '0.828', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.36', 'ciLowerLimit': '-11.223', 'ciUpperLimit': '-5.493', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.458', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 24 in Apo B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.39', 'spread': '2.090', 'groupId': 'OG000'}, {'value': '-8.61', 'spread': '1.267', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.00', 'ciLowerLimit': '-17.829', 'ciUpperLimit': '-8.175', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.451', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 52 in Apo B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '464', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.01', 'spread': '1.502', 'groupId': 'OG000'}, {'value': '-6.56', 'spread': '0.983', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.58', 'ciLowerLimit': '-13.107', 'ciUpperLimit': '-6.047', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.796', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 24 in hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.563', 'groupId': 'OG000', 'lowerLimit': '-32.174', 'upperLimit': '47.500'}, {'value': '-24.107', 'groupId': 'OG001', 'lowerLimit': '-51.502', 'upperLimit': '14.035'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.278', 'ciLowerLimit': '-32.250', 'ciUpperLimit': '-10.034', 'estimateComment': 'The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percent Change From Baseline to Week 52 in hsCRP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '465', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.250', 'groupId': 'OG000', 'lowerLimit': '-39.286', 'upperLimit': '41.810'}, {'value': '-16.727', 'groupId': 'OG001', 'lowerLimit': '-50.877', 'upperLimit': '31.429'}]}]}], 'analyses': [{'pValue': '0.102', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Location shift', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.587', 'ciLowerLimit': '-16.978', 'ciUpperLimit': '1.653', 'estimateComment': 'The location shift and asymptotic 95% confidence interval are based on Hodges-Lehman estimation.', 'statisticalMethod': 'Wilcoxon Rank Sum Test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline to Week 52 in LDL-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'OG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.71', 'spread': '2.216', 'groupId': 'OG000'}, {'value': '-19.78', 'spread': '1.433', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.07', 'ciLowerLimit': '-20.260', 'ciUpperLimit': '-9.878', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.641', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data. Change from Baseline in LDL-C was analyzed using an ANCOVA model with change from baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and baseline as a covariate.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set. Only participants with available data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'FG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '522'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '490'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Moved out of the country', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Could not attend study visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'A total of 779 participants were randomized 2:1 to receive either bempedoic acid or placebo.', 'preAssignmentDetails': 'The study consisted of 3 periods: a 1-week screening period; a 4-week single-blind, placebo run-in period; and a 52-week double-blind, randomized treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '522', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received placebo once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'BG001', 'title': 'Bempedoic Acid', 'description': 'Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '8.73', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '8.82', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '8.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '328', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '244', 'groupId': 'BG000'}, {'value': '491', 'groupId': 'BG001'}, {'value': '735', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean low-density lipoprotein cholesterol (LDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '122.4', 'spread': '38.30', 'groupId': 'BG000'}, {'value': '119.4', 'spread': '37.75', 'groupId': 'BG001'}, {'value': '120.43', 'spread': '37.931', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL-C category', 'classes': [{'title': '<130 mg/dL', 'categories': [{'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}]}, {'title': '≥130 and <160 mg/dL', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': '≥160 mg/dL', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean non-high-density lipoprotein cholesterol (non-HDL-C)', 'classes': [{'categories': [{'measurements': [{'value': '153.7', 'spread': '44.36', 'groupId': 'BG000'}, {'value': '150.7', 'spread': '42.75', 'groupId': 'BG001'}, {'value': '151.7', 'spread': '43.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean total cholesterol (TC)', 'classes': [{'categories': [{'measurements': [{'value': '204.8', 'spread': '46.06', 'groupId': 'BG000'}, {'value': '202.1', 'spread': '42.71', 'groupId': 'BG001'}, {'value': '203.0', 'spread': '43.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean apolipoprotein B (apoB)', 'classes': [{'categories': [{'measurements': [{'value': '118.6', 'spread': '30.53', 'groupId': 'BG000'}, {'value': '116.2', 'spread': '29.58', 'groupId': 'BG001'}, {'value': '117.0', 'spread': '29.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline was defined as the last non-missing value on or prior to Day 1.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Median high-sensitivity C-reactive protein (hsCRP)', 'classes': [{'categories': [{'measurements': [{'value': '1.880', 'groupId': 'BG000', 'lowerLimit': '0.920', 'upperLimit': '3.790'}, {'value': '1.610', 'groupId': 'BG001', 'lowerLimit': '0.870', 'upperLimit': '3.455'}, {'value': '1.700', 'groupId': 'BG002', 'lowerLimit': '0.870', 'upperLimit': '3.560'}]}]}], 'paramType': 'MEDIAN', 'description': 'Baseline was defined as the last non-missing value on or prior to Day 1. Dispersion data are reported as the first quartile and third quartile values.', 'unitOfMeasure': 'milligrams per Liter', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Median triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '143.00', 'groupId': 'BG000', 'lowerLimit': '106.00', 'upperLimit': '189.00'}, {'value': '139.25', 'groupId': 'BG001', 'lowerLimit': '102.50', 'upperLimit': '190.00'}, {'value': '140.00', 'groupId': 'BG002', 'lowerLimit': '103.00', 'upperLimit': '189.50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Concomitant lipid-modifying therapy (LMT) medications', 'classes': [{'title': 'Statins', 'categories': [{'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '478', 'groupId': 'BG001'}, {'value': '710', 'groupId': 'BG002'}]}]}, {'title': 'Fibrates', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Nicotinic acid and derivatives', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other lipidmodifying therapies', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Bile acid sequestrants', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Concomitant medications were defined as medications that were ongoing at the time of double-blind investigational medicinal product (IMP) initiation or new medications that started after double-blind IMP initiation and within 30 days following the date of the last dose of IMP. Other LMT included ezetimibe, fish oil, omega-3 fatty acids, omega-3-acid ethyl ester, alirocumab, evolocumab, and kolestop. Data are reported for participants who took at least one concomitant LMT.', 'unitOfMeasure': 'Participants'}, {'title': 'History of atherosclerotic cardiovascular disease (ASCVD)', 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '495', 'groupId': 'BG001'}, {'value': '736', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data for participants with ASCVD only (without heterozygous familial hypercholesterolemia \\[HeFH\\]) are reported.', 'unitOfMeasure': 'Participants'}, {'title': 'History of HeFH', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Data for participants with HeFH (with or without ASCVD) are reported.', 'unitOfMeasure': 'Participants'}, {'title': 'History of impaired fasting glucose', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Background LMT', 'classes': [{'title': 'Statins with or without other LMTs', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}, {'value': '470', 'groupId': 'BG001'}, {'value': '698', 'groupId': 'BG002'}]}]}, {'title': 'Statins without other LMTs', 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '416', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}]}]}, {'title': 'Statins with other LMTs', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': 'Other LMTs without statins', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'No LMT or statin', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Disease history', 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '438', 'groupId': 'BG001'}, {'value': '662', 'groupId': 'BG002'}]}]}, {'title': 'Coronary heart disease', 'categories': [{'measurements': [{'value': '205', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '637', 'groupId': 'BG002'}]}]}, {'title': 'Diabetes', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}]}, {'title': 'Impaired fasting glucose', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The presence of these conditions was determined by participant-reported medical history.', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '30.64', 'spread': '5.048', 'groupId': 'BG000'}, {'value': '30.01', 'spread': '5.192', 'groupId': 'BG001'}, {'value': '30.22', 'spread': '5.150', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI was calculated as weight in kilograms divided by height in meters squared.', 'unitOfMeasure': 'kilograms per meters squared (kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estimated glomerular filtration rate (eGFR) category', 'classes': [{'title': '≥90 mL/min/1.73 m^2', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}, {'title': '≥60 to <90 mL/min/1.73 m^2', 'categories': [{'measurements': [{'value': '164', 'groupId': 'BG000'}, {'value': '338', 'groupId': 'BG001'}, {'value': '502', 'groupId': 'BG002'}]}]}, {'title': '<60 mL/min/1.73 m^2', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'eGFR was measured in milliliters per minutes per 1.73 meters squared (mL/min/1.73 m\\^2).', 'unitOfMeasure': 'Participants'}, {'title': 'Statin intensity', 'classes': [{'title': 'Low intensity or no statin', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': 'Moderate intensity', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}, {'title': 'High intensity', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline statin intensity were based on stratification at randomization. Low-intensity statins: simvastatin 10 milligrams (mg); pravastatin 10-20 mg; lovastatin 20 mg; fluvastatin 20-40 mg; pitavastatin 1 mg. Moderate-intensity statins: atorvastatin 10-20 mg; rosuvastatin 5-10 mg; simvastatin 20 mg; pravastatin 40-80 mg; lovastatin 40 mg; fluvastatin XL 80 mg; fluvastatin 40 mg twice a day; pitavastatin 2-4 mg. High-intensity statins: atorvastatin 40-80 mg; rosuvastatin 20-40 mg.', 'unitOfMeasure': 'Participants'}, {'title': 'Numer of participants receiving ezetimibe', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-09', 'size': 3642153, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-17T09:43', 'hasProtocol': True}, {'date': '2018-06-14', 'size': 1548635, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-17T09:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 779}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'dispFirstSubmitDate': '2018-11-08', 'completionDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-24', 'studyFirstSubmitDate': '2016-12-09', 'dispFirstSubmitQcDate': '2018-11-08', 'resultsFirstSubmitDate': '2020-03-20', 'studyFirstSubmitQcDate': '2016-12-09', 'dispFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-24', 'studyFirstPostDateStruct': {'date': '2016-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percent Change From Baseline to Week 12 in Triglycerides (TGs)', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the TG values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in TG was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 12 in HDL-C', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 52 in LDL-C', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 24 in Non-HDL-C', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 52 in Non-HDL-C', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline was defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 24 in TC', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 52 in TC', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline was defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 24 in Apo B', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 52 in Apo B', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate.'}, {'measure': 'Percent Change From Baseline to Week 24 in hsCRP', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100.'}, {'measure': 'Percent Change From Baseline to Week 52 in hsCRP', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100.'}, {'measure': 'Change From Baseline to Week 52 in LDL-C', 'timeFrame': 'Baseline; Week 52', 'description': 'Baseline was defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data. Change from Baseline in LDL-C was analyzed using an ANCOVA model with change from baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and baseline as a covariate.'}], 'primaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (atherosclerotic cardiovascular diseases \\[ASCVD\\] and heterozygous familial hypercholesterolemia \\[HeFH\\]) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 12 are imputed using multiple imputation method taking into account adherence to treatment.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline to Week 24 in LDL-C', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in LDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing LDL-C data at Week 24 were imputed using multiple imputation method taking into account adherence to treatment.'}, {'measure': 'Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the non-HDL-C values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in non-HDL-C was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing non-HDL-C data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.'}, {'measure': 'Percent Change From Baseline to Week 12 in Total Cholesterol (TC)', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the TC values from the last two non-missing values on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in TC was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing TC data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.'}, {'measure': 'Percent Change From Baseline to Week 12 in Apolipoprotein b (Apo B)', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline for apo B was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100. Percent change from Baseline in apo B was analyzed using an ANCOVA model with percent change from Baseline as the dependent variable, treatment, cardiovascular risk (ASCVD and HeFH) crossed with Baseline statin intensity (low/moderate and high) as fixed effects and Baseline as a covariate. In the ANCOVA model, missing apo B data at Week 12 were imputed using multiple imputation method taking into account adherence to treatment.'}, {'measure': 'Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline for hsCRP was defined as the last non-missing value on or prior to Day 1. Percent change from Baseline is calculated as (\\[post-baseline value minus baseline value\\] divided by \\[baseline value\\]) multiplied by 100.'}, {'measure': 'Change From Baseline to Week 12 in LDL-C', 'timeFrame': 'Baseline; Week 12', 'description': 'Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data.'}, {'measure': 'Change From Baseline to Week 24 in LDL-C', 'timeFrame': 'Baseline; Week 24', 'description': 'Baseline is defined as the mean of the LDL-C values from the last two non-missing values on or prior to Day 1. Change from Baseline is calculated as the post-baseline value minus the baseline value. Analysis was conducted using descriptive statistics by treatment group using observed data.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hyperlipidemia', 'cholesterol', 'familial hypercholesterolemia', 'atherosclerotic cardiovascular disease', 'ASCVD', 'HeFH', 'LDL'], 'conditions': ['Hypercholesterolemia', 'Atherosclerotic Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '31714986', 'type': 'BACKGROUND', 'citation': 'Goldberg AC, Leiter LA, Stroes ESG, Baum SJ, Hanselman JC, Bloedon LT, Lalwani ND, Patel PM, Zhao X, Duell PB. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease: The CLEAR Wisdom Randomized Clinical Trial. JAMA. 2019 Nov 12;322(18):1780-1788. doi: 10.1001/jama.2019.16585.'}, {'pmid': '27892461', 'type': 'BACKGROUND', 'citation': 'Pinkosky SL, Newton RS, Day EA, Ford RJ, Lhotak S, Austin RC, Birch CM, Smith BK, Filippov S, Groot PHE, Steinberg GR, Lalwani ND. Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis. Nat Commun. 2016 Nov 28;7:13457. doi: 10.1038/ncomms13457.'}, {'pmid': '21067804', 'type': 'BACKGROUND', 'citation': "Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8."}, {'pmid': '26039521', 'type': 'BACKGROUND', 'citation': 'Cannon CP, Blazing MA, Giugliano RP, McCagg A, White JA, Theroux P, Darius H, Lewis BS, Ophuis TO, Jukema JW, De Ferrari GM, Ruzyllo W, De Lucca P, Im K, Bohula EA, Reist C, Wiviott SD, Tershakovec AM, Musliner TA, Braunwald E, Califf RM; IMPROVE-IT Investigators. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015 Jun 18;372(25):2387-97. doi: 10.1056/NEJMoa1410489. Epub 2015 Jun 3.'}, {'pmid': '23461430', 'type': 'BACKGROUND', 'citation': 'Robinson JG. Management of familial hypercholesterolemia: a review of the recommendations from the National Lipid Association Expert Panel on Familial Hypercholesterolemia. J Manag Care Pharm. 2013 Mar;19(2):139-49. doi: 10.18553/jmcp.2013.19.2.139.'}, {'pmid': '24222016', 'type': 'BACKGROUND', 'citation': 'Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. No abstract available.'}, {'pmid': '35916348', 'type': 'DERIVED', 'citation': 'Ballantyne CM, Bays HE, Louie MJ, Smart J, Zhang Y, Ray KK. Factors Associated With Enhanced Low-Density Lipoprotein Cholesterol Lowering With Bempedoic Acid. J Am Heart Assoc. 2022 Aug 2;11(15):e024531. doi: 10.1161/JAHA.121.024531. Epub 2022 Aug 2.'}, {'pmid': '32609313', 'type': 'DERIVED', 'citation': 'Banach M, Duell PB, Gotto AM Jr, Laufs U, Leiter LA, Mancini GBJ, Ray KK, Flaim J, Ye Z, Catapano AL. Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia. JAMA Cardiol. 2020 Oct 1;5(10):1124-1135. doi: 10.1001/jamacardio.2020.2314.'}], 'seeAlsoLinks': [{'url': 'http://www.who.int/mediacentre/factsheets/fs317/en/', 'label': 'World Health Organization Fact Sheet No. 317'}, {'url': 'https://thefhfoundation.org/about-fh/what-is-fh/', 'label': 'What Is Familial Hypercholesterolemia'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol not adequately controlled by their current therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fasting LDL-C ≥100 mg/dL\n* High cardiovascular risk (diagnosis of HeFH and/or ASCVD)\n* Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated statin either alone or in combination with other LMTs\n\nExclusion Criteria:\n\n* Total fasting triglyceride ≥500 mg/dL\n* Renal dysfunction or nephrotic syndrome or history of nephritis\n* Body Mass Index (BMI) ≥50kg/m2\n* Significant cardiovascular disease or cardiovascular event in the past 3 months'}, 'identificationModule': {'nctId': 'NCT02991118', 'acronym': 'CLEAR Wisdom', 'briefTitle': 'Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esperion Therapeutics, Inc.'}, 'officialTitle': 'A Long-term, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk Not Adequately Controlled by Their Lipid-Modifying Therapy', 'orgStudyIdInfo': {'id': '1002-047'}, 'secondaryIdInfos': [{'id': '2016-003486-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bempedoic acid', 'description': 'bempedoic acid 180 mg/day', 'interventionNames': ['Drug: bempedoic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo control', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'bempedoic acid', 'type': 'DRUG', 'otherNames': ['ETC-1002'], 'description': 'bempedoic acid 180 mg tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided)', 'armGroupLabels': ['bempedoic acid']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['placebo control'], 'description': 'Matching placebo tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Georgetown', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.63269, 'lon': -97.67723}}], 'overallOfficials': [{'name': 'Ron Haberman, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Esperion Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esperion Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}