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Das Auftreten von unerwarteten schwerwiegenden Produktwirkungen (USADEs) knnte darauf hindeuten, dass die klinische Prfung fr die Probanden ein hheres Schadensrisiko darstellt, als zuvor erwartet wurde, und kann Konsequenzen fr die Fortfhrung der Studie haben (MDCG 2020-10 und ISO14155:2011/AC2011)