- Baseline abnormalities in hepatic tests (AST > 5.0 X study center upper limit of normal (ULN); ALT > 5.0 X study center ULN; albumin < 2.8 g/dL; international normalized ratio for prothrombin time (INR) > 1.5 X study center ULN; total bilirubin > 3.0 x study center ULN).