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Wenn sie in die Kategorie der schwerwiegenden unerwnschten Ereignisse fallen, mssen sie den Behrden der Lnder, in denen die Studie stattfindet, gemeldet werden (MDR und Leitfaden MDCG 2020-10/1 "Safety reporting in clinical examinations of medical devices under the Regulation (EU) 2017/745")

While it shares some similarities in promoting muscle growth and recovery, it works through a different biological mechanism and is classified as a peptide hormone, not a steroid

Other commenters supported CMS's decision to introduce the measure through voluntary reporting