 - Prothrombin time PTinternational normalized ratio INR and partial thromboplastin time PTT 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with PTINRPTT established within the therapeutic range prior to randomization; subjects will be eligible if it is determined by a hematologist that the cause is not associated with clinical bleeding e.g., deficiency of factor XII, within 2 weeks of the first dose of study treatment 