 - The following criteria for evidence of adequate hepatic function must be met: Total bilirubin must be less than or equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation ULN to 1.5 x ULN due to Gilberts disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be 2.5 x ULN for the lab; and 