25. Has aspartate aminotransferase or alanine aminotransferase >1.5 × upper limit of normal (ULN); alkaline phosphatase or bilirubin 1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination;