 - Renal or liver impairment, defined as alkaline phosphatase andor bilirubin 1.5 x ULN an isolated bilirubin 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is 35, serum creatinine level of 123.76 μmolL 1.4 mgdL in females and 132.60 μmolL 1.5 mgdL in males, and 2 × ULN for liver transaminases ALT and AST, respectively. 