19.Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2× ULN, severe hepatic insufficiency (classification Child Pugh C), biliary cirrhosis, cholestasis (current or anamnesic evidence), history of hepatic encephalopathy, history of esophageal varices, or history of portocaval shunt. This evidence concerns the gene GPT and cholestasis.