Duration of the trial
The trial duration will be variable. Unless completed early because of recommendation of the Data and Safety Monitoring Board on the basis of a statistically significant interim analysis, the trial will continue until 925 patients have reached the primary endpoint (stroke). For planning purposes, the expected enrolment period will be 2 years and the expected average follow-up period will be 4 years for a total expected follow-up period of 5 years. At the end of the 2 years enrolment period if enrolment of the planned number of patients is not completed or event rate is lower than expected, adjustments to the enrolling period may be made to facilitate successful completion of the trial.