11.4 Major event analysis (Efficacy and safety analysis) Major events analyses, primarily the TE event rate (efficacy) but also the secondary end points of the rate of bleeding and major bleeding (safety) as well as the combined endpoint of TE events and major bleeding events will be based on the ITT population. For the primary and secondary endpoints, event free survival will be compared in the two groups using Kaplan-Meier curves. Optionally, the time to the first events will be analyzed using Cox's proportional hazard models.