11. Liver function tests must not be above the following cut-offs: ALT and/or AST >3.0X ULN, AP >1.5X ULN and total bilirubin >ULN. (If all LFTs are WNL and total bilirubin is elevated, a retest of direct and indirect bilirubin may be performed. Subjects with indirect total bilirubin up to 3X ULN (presumed Gilbert's syndrome) may be enrolled if all other LFTs are WNL.)