- Significant thrombotic or embolic events within 3 months prior to Study Day 1. Significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack (TIA). Catheter-related thrombosis is not a cause for exclusion. Diagnosis of deep vein thrombosis or pulmonary embolism is allowed if it occurred > 3 months prior to Study Day 1 and the patient has completed or is on stable anti-coagulation therapy.