7.2 Efficacy and safety outcome criteria for the IAC 7.2.1 Assessment of clinical outcomes All suspected clinical outcomes i.e. recurrent TE, bleeding, death and vascular events, will be notified expedited to the IAC in a manner blinded to which test was applied. Blinded review of the event by the IAC should be completed within 2-4 weeks after occurrence of the event. The primary efficacy outcome is symptomatic or fatal recurrent arterial or venous TE event during the study period. The primary safety outcome is bleeding. Prespecified criteria for these events are excluded from this abbreviated protocol version.