 - International normalized ratio INR Partial thromboplastin time PTT 1.5 x ULN. Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INRPTT is stable based on a measurement that is pre-dose as defined by the local standard of care. 