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CHAPTER 2.1 40 Supplementary table 1 (continued). Characteristics, inclusion and exclusion criteria of trials Study name BEAUTIFUL CONFIRM-HF FAIR-HF PANTHEON SHIFT Known severe renal disease Serum creatinine > 200 micromoles/L Renal dialysis (previous, current or planned within the next 6 months). Immunosuppressiv e therapy or renal dialysis (current or planned within the next 6 months). Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 calculated by Modification of Diet in Renal Disease formula within 3 months prior to randomization. If several values are available, thelatest result should be used. Known severe renal disease (serum creatinine > 220 μmol/L) Known carriers of hepatitis B surface antigen or hepatitis C virus antibodies Known severe liver disease ALT or ALT > 3 times upper normal values Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range. Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range. Hepatic insufficiency classified as Child-Pugh B or C, or any of the following: - Primary biliary cirrhosis (PBC) - Primary sclerosing cholangitis - PBC-autoimmune hepatitis overlap syndrome Known carriers of hepatitis B surface antigen or hepatitis C virus antibodies Known moderate or severe liver disease (Child-Pugh score > 7) ALT and/or AST > 3 times the upper normal values

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