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Authors
Herold, Stephanie https://orcid.org/0000-0002-8335-8790
Schmidt, Christian
Visco, Carlo
Tilch, Marie-Kristin
Ohler, Anke
Unterhalt, Michael
Hoster, Eva
Hoenig, Elisabeth
Singer, Susanne
Tucci, Alessandra
Pott, Christiane
Ladetto, Marco
Hess, Georg
Dreyling, Martin
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Funding
Funding for this research was provided by:
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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Article History
Received: 27 May 2025
Accepted: 4 August 2025
First Online: 25 August 2025
Declarations
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: This trial is conducted in accordance with the ethical principles of the Declaration of Helsinki. All participants are informed about the study objectives, procedures, potential risks and benefits, and their rights to withdraw at any time without affecting their medical care. Written informed consent is obtained from all participants before enrollment and prior to the conduct of any study-related procedures.According to national regulations, the study was approved by the competent authority Federal Institute for Drugs and Medical Devices (BfArM) and received a favorable opinion of the appropriate Ethic’s Committees. The study is conducted in accordance with Good Clinical Practice guidelines, the German Medicines Act (AMG) and after transition in accordance with EU Regulation 536/2014. The trial is registered on EU Clinical Trial Register (2022-501808-96-00).
: Not applicable.
: The authors declare no competing interests.
