GPT and esophageal varices: Two (2%) patients had a Grade 3–4 AE (elevations of ALT and aspartate transaminase (AST) in one patient, and cirrhosis, hepatic neoplasm malignant, and esophageal varices in one patient who discontinued from study prematurely and subsequently was lost to follow up); these were considered by the investigator to be unrelated to study drug.