- Liver safety criteria: Alanine aminotransferase (ALT) <=2×the upper limit of normal (ULN), Alkaline phosphatase and bilirubin <=1.5×ULN (isolated bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%) at Visit 1 (Screening and Run-in Visit)