- Documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody) at Screening, and/or clinically significant hepatic enzyme elevation 13.Subjects who are not euthyroid as evidenced by normal TSH (subjects maintained on thyroid medication must be euthyroid for a period of at least six months prior to the screen visit).