Abbreviations used in clinical trials

ABI Ankle-brachial index ACC American College of Cardiology ACCORD Action to Control Cardiovascular Risk in Diabetes ACS Acute coronary syndrome AE Adverse event AHA American Heart Association AIDS Acquired immune deficiency syndrome AIM-HIGH Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes ALT Alanine aminotransferase AMR101 Ethyl-EPA; ethyl eicosapentaenoic acid; icosapent ethyl ANCHOR Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins with High TG Levels (≥ 200 and < 500 mg/dL) AP Angina pectoris apo B Apolipoprotein B APOC3 Apolipoprotein C3 AST Aspartate aminotransferase ATP Adult Treatment Panel BMI Body mass index BUN Blood urea nitrogen CABG Coronary artery bypass graft CAD Coronary artery disease CBC Complete blood count CEC Clinical Endpoint Committee CHD Coronary heart disease CHF Congestive heart failure CI Confidence interval CK-MB Creatine kinase-MB fraction CrCL Creatinine clearance CRF Case report form CV Cardiovascular CVD Cardiovascular disease DART Diet and Reinfarction Trial DCCT Diabetes Control and Complications Trial DHA Docosahexaenoic acid DMC Data Monitoring Committee DYSIS The DYSlipidemia International Study EC Independent Ethics Committee ECG Electrocardiogram EDC Electronic data capture eGRF Estimated glomerular filtration rate EPA Eicosapentaenoic acid Ethyl-EPA AMR101; ethyl eicosapentaenoic acid; icosapent ethyl EU European Union FBG Fasting blood glucose FDA United States Food and Drug Administration FSH Follicle-stimulating hormone GCP Good Clinical Practice GGT Gamma-glutamyl transferase GISSI Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico GMP Good Manufacturing Practice GWAS Genome-wide association study HbA1c Hemoglobin A1c Hct Hematocrit HDL-C High-density lipoprotein cholesterol HF Heart failure Hgb Hemoglobin HIV Human immunodeficiency virus HPS2-THRIVE Heart Protection Study 2–Treatment of HDL to Reduce the Incidence of Vascular Events HR Hazard ratio hs-CRP High-sensitivity C-reactive protein hsTnT High-sensitivity troponin T HTG Hypertriglyceridemia ICF Informed consent form ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use IFCC International Federation of Clinical Chemistry IMP Investigational medicinal product IQR Interquartile range IRB Institutional Review Board ITT Intent-to-Treat IWRS Interactive Web Response System JAS Japanese Atherosclerosis Society JELIS Japan Eicosapentaenoic Acid Lipid Intervention Study LBBB Left bundle branch block LDL-C Low-density lipoprotein cholesterol LOE Lack of efficacy LpPLA2 Lipoprotein-associated phospholipase A2 LVH Left ventricle hypertrophy MACE Major adverse coronary event MARINE Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (TG) Levels ≥ 500 and ≤ 2000 mg/dL MI Myocardial infarction mITT Modified Intent-to-Treat NCEP National Cholesterol Education Program NGSP National Glycohemoglobin Standardization Program NMR Nuclear magnetic resonance NSTE-ACS Non-ST-segment elevation acute coronary syndrome O3FA Omega-3 fatty acid ODIS Off drug in study OGTT Oral glucose tolerance test OR Odds ratio PAD Peripheral arterial disease PCI Percutaneous coronary intervention PCSK9 Proprotein convertase subtilisin kexin 9 PH Proportional hazard PI Principal Investigator PP Per protocol PROVE-IT Pravastatin or Atorvastatin Evaluation and Infection Therapy PVD Peripheral vascular disease RBC Red blood cells REDUCE-IT Reduction of Cardiovascular Events with EPA – Intervention Trial RLP-C Remnant lipoprotein cholesterol RR Relative risk SAE Serious adverse event SAP Statistical Analysis Plan SC Steering Committee SPC Summary of Product Characteristics SUSAR Suspected unexpected serious adverse reaction TC Total cholesterol TEAE Treatment-emergent adverse event TG Triglycerides TIA Transient Ischemic Attack TIMI Thrombolysis In Myocardial Infarction ULN Upper limit of normal US United States USPI United States Prescribing Information VLDL-C Very low density lipoprotein cholesterol WBC White cell blood count