Abbreviations used in clinical trials

ABI Ankle-brachial index

ACC American College of Cardiology

ACS Acute coronary syndrome

AE Adverse event

AHA American Heart Association

AIDS Acquired immune deficiency syndrome

ALT Alanine aminotransferase

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

DHA Docosahexaenoic acid

DMC Data Monitoring Committee

EC Independent Ethics Committee

ECG Electrocardiogram

EDC Electronic data capture

eGRF Estimated glomerular filtration rate

EPA Eicosapentaenoic acid

Ethyl-EPA ethyl eicosapentaenoic acid

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

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

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