- Subject has any of the liver enzymes (aspartate aminotransferase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT]) or total bilirubin (TBIL) above the upper limit of normal (ULN). If any liver enzyme is > 1 x ULN but ≤ 1.5 x ULN, the assessment may be repeated once during the screening period or on check-in. If the repeated assessment is above the ULN, it is exclusionary. If the initial value is > 1.5 x ULN, it cannot be repeated and is exclusionary.