12. Patients with pre-existing cirrhosis or hepatic impairment or with abnormal liver function test as evidenced by total bilirubin > 1.5 x ULN or 2 times the upper limit of normal of alkaline phosphatase (ALP), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) on the most recent blood work, done at least within the previous 2 weeks.