 - Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities with the exception of Gilberts syndrome or asymptomatic gallstones. Chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria and are not on active antiviral treatment e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of screening 