- Patients with evidence of hepatic dysfunction [alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal (ULN), bilirubin greater than 1.5 times ULN, or cirrhosis] or renal dysfunction (serum creatinine greater than 140 μmol/l, or nephrotic syndrome) as measured during the baseline phase