 - Abnormal baseline hematologic or coagulation parameters as defined as: absolute neutrophil count ANC 1.5 x 109L; hemoglobin 9.0 gdL; platelets 100 x 109L; International Normalized Ratio INR of prothrombin time PT 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants; Activated Partial Thromboplastin Time aPTT 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants 