 16. Evidence of bleeding diathesis, coagulopathy as documented by an elevated 1.5 x ULN prothrombin time PT, partial thromboplastin time PTT, or bleeding time. The use of full-dose oral or parenteral anticoagulants is permitted as long as the PT or aPTT is within therapeutic limits according to the medical standard of the enrolling institution and the subject has been on a stable dose of anticoagulants for at least 2 weeks prior to the first study treatment. 