 32. Have relevant clinical laboratory abnormalities, including any elevation of alanine aminotransferase ALT, aspartate aminotransferase AST, or bilirubin at screening. If the investigator concludes that there is no safety risk for subjects with isolated laboratory abnormalities eg, those that do not reflect end-organ dysfunction; for example, elevated bilirubin in Gilberts subjects to participate in the study, such cases need to be discussed and approved by the sponsors medical monitor prior to study enrollment 