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QUESTION: In adults who have a high risk for cardiovascular events, do vitamin E supplements improve cardiovascular outcomes?
Design
Randomised {allocation concealed*}†, blinded {patients, clinicians, and outcome assessors}‡,* placebo controlled trial with a 2 × 2 factorial design and a mean follow up of 4.5 years (Heart Outcomes Prevention Evaluation [HOPE] study).
Setting
{161 centers in North America, 76 in 14 western European countries, and 30 in Argentina and Brazil.}‡
Patients
9541 patients (mean age 66 y, 73% men) who were {≥55 years of age and had a history of coronary artery disease, stroke, peripheral vascular disease, or diabetes and ≥1 other cardiovascular disease risk factor. Exclusion criteria were heart failure, ejection …