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Article History

Received: 16 May 2025

Accepted: 18 August 2025

First Online: 13 October 2025

Declarations

:

: The study was conducted adhering to the principles of Good Clinical Practice and the Declaration of Helsinki. The independent ethics committees of all participating centers approved the study (University Hospital of Wuerzburg study number 301/13_ff).

: Not applicable.

: The authors W.B., C.F., S.F., T.H., H.I., A.K., M.K., U.M., C.R., H.R, K.R., T.R., S. R.-D., G. S.-K., E.T., F.T., C.W., report no conflicts of interest. R.T., M.G., M.R., P.L.P. and K.E. received grant research support from BfArM. M.R. received a research grant from Kids-Safe, Innovation Committee of the German Federal Joint Committee (G-BA grant number 01NVF16021). M.S.-C. received an advisor honorarium from Rovi. C.U.C. has been a consultant and/or advisor to or has received honoraria from: AbbVie, Alkermes, Allergan, Angelini, Aristo, Autobahn, Boehringer-Ingelheim, Bristol-Meyers Squibb, Cardio Diagnostics, Cerevel, CNX Therapeutics, Compass Pathways, Darnitsa, Delpor, Denovo, Draig, Eli Lilly, Eumentis Therapeutics, Gedeon Richter, GH, Hikma, Holmusk, IntraCellular Therapies, Jamjoom Pharma, Janssen/J&J, Karuna, LB Pharma, Lundbeck, MedInCell, MedLink, Merck, Mindpax, Mitsubishi Tanabe Pharma, Maplight, Mylan, Neumora Therapeutics, Neuraxpharm, Neurocrine, Neurelis, Newron, Noven, Novo Nordisk, Otsuka, PPD Biotech, Recordati, Relmada, Response Pharmaeutical, Reviva, Rovi, Saladax, Sanofi, Seqirus, Servier, Sumitomo Pharma America, Sunovion, Sun Pharma, Supernus, Tabuk, Takeda, Teva, Terran, Tolmar, Vertex, Viatris and Xenon Pharmaceuticals. He provided expert testimony for Janssen, Lundbeck and Otsuka. He served on a Data Safety Monitoring Board for Compass Pathways, IntraCellular Therapies, Relmada, Reviva, Rovi. He has received grant support from Boehringer-Ingelheim, Janssen and Takeda. He received royalties from UpToDate and is also a stock option holder of Cardio Diagnostics, Kuleon Biosciences, LB Pharma, MedLink Global, Mindpax, Quantic, Terran.P.H. reports grants from the German Ministry of Research and Education, European Union, Berlin Chamber of Physicians, German Parkinson Society, University Hospital Wuerzburg, Robert Koch Institute, German Heart Foundation, Federal Joint Committee (G-BA) within the Innovationfond, German Research Foundation, Bavarian State (ministry for science and the arts), German Cancer Aid, grants from Charité—Universitätsmedizin Berlin (within Mondafis; Mondafis is supported by an unrestricted research grant to the Charité from Bayer), University Göttingen (within FIND-AF randomized; FIND-AF randomized is supported by an unrestricted research grant to the University Göttingen from Boehringer-Ingelheim), University Hospital Heidelberg (within RASUNOA-prime; RASUNOA-prime is supported by an unrestricted research grant to the University Hospital Heidelberg from Bayer, BMS, Boehringer-Ingelheim, and Daiichi Sankyo).P.L.P. received grant research support from the German Federal Ministry of Education and Research (BMBF) and was involved in clinical trials from Servier and Lundbeck; he received an advisor honorarium from Boehringer-Ingelheim and speaker’s honoraria from Shire, Infectopharm, Janssen, Medice and Gerot Lannach as well as royalties from Hogrefe publishers.A.H. has received compensation for serving as consultant or speaker for Shire–Takeda and Medice, unrelated to this work.