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8/100 patient-years). The Cox regression analysis did not show any relationships among GIB and the variables considered. The patients' clinical history is neither a predictor for GIB bleeding nor a guide to the choice of the oral anticoagulant to be administered. Routinely applying bleeding risk screening, such as occult blood in the stool, should be added to the periodic laboratory checks for early recognition of patients at higher risk of GIB. The patients' clinical history is neither a predictor for GIB bleeding nor a guide to th

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ication after completion of the study. The DAVOS study will be conducted in accordance with the valid version of the present study protocol and the internationally recognized International Conference on Harmonization-Good Clinical Practice (ICH-GCP) Guidelines. Special attention will be paid to European, national, and regional requirements for the approval, provision, and use of medical devices. The study was registered in the German Register of Clinical Trials (DRKS) with number DRKS00025996.Catastrophic antiphospholipid syndrome (CAPS)