4.5 Study management: The study will be managed from day to day by an Executive Committee (EXC) . All clinical diagnoses will be reviewed by a blinded Independent Adjudication Committee (IAC) and Data Safety Monitoring Board (DSMB). The IAC and DSMB will be blinded to which test group the patient with event for review belongs. All suspected recurrent TEs, deaths, as well as all episodes of bleeding and other possible vascular events will be evaluated by the IAC. The patent holders (PTÖ, BRG) will not be on the IAC due to potential bias. Only adjudicated results will be the basis for the final analyses. The DSMB will also monitor the study progress and patients' safety during the study and give recommendations to the EXC.