 - Bilirubin less than or equal to 1.5 times ULN unless, during screening, the patient is receiving protease inhibitor therapy i.e. indinavir, ritonavir, nelfinavir, and atazanavir known to be associated with increased bilirubin: in this case total bilirubin less than or equal to 7.5 mgdl and the direct fraction is less than or equal to 0.7 mgdl. 