 - Severe hepatic dysfunction as defined by liver function tests ALT, ALP, AST, total bilirubin 3.0 times the upper limit of normal. as determined by the following limits from a baseline CMP obtained within the past 7 days. If a CMP has not been performed within the past 7 days, baseline levels may be used from a CMP performed within the past 2 months as long as another CMP is performed on the day of enrollment and the subjects levels are within the following limits. 