 4. Patients must have adequate renal and hepatic function: -- Total bilirubin 1.5 x upper limit of normal ULN. -- For patients with Gilberts disease, total bilirubin up to 3 x ULN is allowed provided normal direct bilirubin. -- Serum creatinine 1.5 x ULN. -- alanine aminotransferase ALT and aspartate aminotransferase AST 3 x ULN. 