METHODS

Design:

randomised controlled trial (RCT) (Japan EPA Lipid Intervention Study [JELIS]).

Allocation:

{concealed*}†.

Blinding:

blinded (outcome assessors, {data analysts, and data safety and monitoring committee}†).*

Follow up period:

mean 4.6 years.

Setting:

Japan.

Patients:

18 645 patients 40–75 years of age (mean age 61 y, 69% postmenopausal women) from Japan with or without coronary artery disease (previous myocardial infarction [MI], coronary interventions, or angina pectoris) who had a total cholesterol concentration ⩾6.5 mmol/l (low density lipoprotein [LDL] cholesterol concentration ⩾4.4 mmol/l). Exclusion criteria included acute MI, cardiovascular (CV) reconstruction, or cerebrovascular disorders in …