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Randomised (allocation concealed), unblinded, 2 × 2 factorial trial with a mean follow up of 3.6 years.
315 general practices and 15 hospital hypertension units in Italy.
4495 patients (mean age 64 y, 58% women) aged ≥50 years who had ≥1 major cardiovascular risk factor: age ≥65 years, hypertension, hypercholesterolaemia, diabetes mellitus, obesity, and family history of myocardial infarction (MI) before 55 years of age in ≥1 parent or sibling. Exclusion criteria were treatment with antiplatelet drugs, chronic use of anti-inflammatory agents or anticoagulants, contraindication …
Sources of funding: Medical Department of Bayer, Italy; aspirin preparation supplied by Bayer; vitamin E capsules supplied by Bracco SpA.
For correspondence: Dr M C Roncaglioni, Istituto di Ricerche Farmacologiche “Mario Negri,” Via Eritrea 62, 20157 Milan, Italy. Fax +39 02 39001916.
A modified version of this abstract also appears in Evidence–Based Medicine.