 - Subject has 2x upper limit of normal ULN of any of the following: alanine aminotransferase ALT, aspartate aminotransferase AST, alkaline phosphatase ALP, or ULN total bilirubin 1.5xULN total bilirubin if known Gilberts syndrome. If subject has elevations only in total bilirubin that are ULN and 1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilberts syndrome ie, direct bilirubin 35 