Proefschrift

Generalizability of HFrEF trials 43 Supplementary table 1 (continued). Characteristics, inclusion and exclusion criteria of trials Study name BEAUTIFUL CONFIRM-HF FAIR-HF PANTHEON SHIFT Body weight ≤35 kg. Body mass index (BMI) > 40 kg/m2 at randomization or a history of poor quality LVEF measurement by echocardiography Patients requiring the following medications: macrolide antibiotics, cyclosporin, gestodene, antiretroviral drugs or azole antifungals such as ketoconazole Vitamin B12 and/or serum folate deficiency. If deficiency corrected subject may be rescreened for inclusion. History of acquired iron overload. History of erythropoietin stimulating agent, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomization. Subject at an immediate need of transfusion or haemoglobin ≥15 g/dL. Vitamin B12 and/or serum folate deficiency according to the central laboratory History of acquired iron overload. History of erythropoietin, IV or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months. Concomitant use of any of the following therapy that cannot be discontinued: - Potent CYP3A4 inhibitors or inducers or strong CYP2C8 inhibitors - Theophylline - Drugs that are mainly metabolized by UGT1A1 (irinotecan) Respective substances must be stopped at least 7 days before randomization. 2.1

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