 7. International normalized ratio INR 1.5 x ULN and partial thromboplastin time PTT or activated partial thromboplastin time aPTT 1.5 x ULN unless receiving treatment with therapeutic anticoagulation. Patients being treated with anticoagulant e.g., heparin, will be allowed to participate provided no prior evidence of an underlying abnormality in these parameters exists. Close monitoring of at least weekly evaluations will be performed until INR and PTT are stable based on a pre-dose measurement as defined by the local standard of care. 