 - PT Prothrombin Time or INR International Normalized Ratio and PTT Partial Thromboplastin Time 1.5 x upper limit of normal patients who receive anti-coagulation treatment with an agent such as warfarin or heparin will be allowed to participate. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement at pre dose, as defined by the local standard of care 