 Hepatic: bilirubin less than or equal to 1.5 times the upper limit of normal ULN, alkaline phosphatase ALP, aspartate transaminase AST, and alanine transaminase ALT less than or equal to 2.0 Renal: calculated creatinine clearance CrCl 45 mLmin based on the standard Cockcroft and Gault formula Cockcroft and Gault 1976. 