 - Patients with active liver disease or hepatic dysfunction as defined by elevations in liver enzymes alanine aminotransferase ALT, aspartate aminotransferase AST, gamma glutamyltransferase GGT and alkaline phosphatase ALP or total bilirubin 2 x the upper limit of normal ULN at any time between Visit 1 Week -4 and Visit 3 Week -1. 