 - International normalized ratio INRpartial thromboplastin time PTT 1.5 x ULN; subjects who are therapeutically 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 