Table 1 Definition of study outcome events

Stroke

Definite: relevant clinical features causing an increase in impairment of at least one grade on the modified Rankin scale, accompanied by an infarction on repeat brain imaging.

Probable: clinical features that have caused an increase in impairment of at least one grade on the modified Rankin scale; without documentation by means of brain imaging.

Myocardial infarction

At least two of the following criteria:

(I) chest pain for at least 20 min, not disappearing after administration of nitrates;

(II) ST-elevation > 1 mm in two following leads or a left bundle branch block on the electrocardiogram;

(III) Creatinine kinase (CK) elevation of at least two times the normal value of CK and a myocardial band-fraction > 5% of the total CK.

Vascular mortality

Death from ischemic or hemorrhagic stroke, congestive heart failure, myocardial infarction or rupture of abdominal aortic aneurysm.

Sudden death: unexpected cardiac death occurring within 1 hour after onset of symptoms, or within 24 hours given convincing circumstantial evidence.

Vascular death from other causes

Composite vascular outcome event

A composite of stroke, myocardial infarction and vascular mortality completed with a probable or definite retinal infarction or bleeding and probable or definite hemorrhagic stroke.

All-cause mortality

Death from any cause