- Adequate organ function, as defined by the following criteria (per central or local laboratory values; see section 7.2): Serum aspartate aminotransferase (AST) ≤ 2.0 x upper limit of normal (ULN)/ Serum alanine aminotransferase ≤ (ALT) 2.0 x ULN/ Serum total bilirubin ≤ 2.0 x ULN/ Creatinine clearance ≥ 30 mL/min/ Serum calcium or albumin-adjusted serum calcium 2.0 mmol/L (8.0 mg/dL) and 2.9 mmol/L (11.5 mg/dL)