6. Adequate organ system function as defined by: PT/PTT/INR ≤ ULN; total bilirubin ≤ 1.5 mg/dL; ALT and AST < 2.5 x ULN if no liver involvement or ≤ 5 x ULN with liver involvement; creatinine ≤ 1.5 x ULN, or calculated or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method, or 24-hour measured urine creatinine clearance ≥ 50 mL/min.