 2. Serum creatinine 1.5 X upper limit of normal or measured or calculated creatinine clearance 60 mLmin; serum total bilirubin 1.5 X ULN; AST and ALT 2.5 X ULN; albumin 2.5 mgdL; international normalized ratio or prothrombin time and activated partial thromboplastin time 1.5 X ULN unless subject is receiving anticoagulant therapy 