CHAPTER 2.1 44 Supplementary table 1 (continued). Characteristics, inclusion and exclusion criteria of trials Study name BEAUTIFUL CONFIRM-HF FAIR-HF PANTHEON SHIFT Women who are pregnant, breast-feeding or women of childbearing potential not using estroprogestative or progestative or intrauterine contraception or women using estroprogestative or intrauterine contraception but who consider stopping it during the planned duration of the study Subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding. Subject is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. Pregnancy or lactation. Women of childbearing potential (women are considered of childbearing potential if they are not surgically sterile or postmenopausal, defined as amenorrhea for > 12 months) Women who are pregnant, breast-feeding or women of childbearing potential not using estroprogestative or progestative or intrauterine contraception or women using estroprogestative or intrauterine contraception but who consider stopping it during the planned duration of the study Unlikely to cooperate in the study Legal incapacity or limited legal incapacity Subject will not be available for all protocol specified assessments. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. Inability to fully comprehend and/or perform study procedures in the investigator’s opinion. Unlikely to cooperate in the studyLegal incapacity or limited legal incapacity Known alcohol or drug abuse Heavy alcohol consumption or the use of illicit drugs that, in the opinion of the investigator, may interfere with the patient’s safety and / or compliance Known alcohol or drug abuse
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