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Authors
Roepke, Stefan https://orcid.org/0000-0003-3165-8684
Schoofs, Nikola
Priebe, Kathlen
Wuelfing, Felix https://orcid.org/0009-0002-4139-0861
Meyer, Kristina https://orcid.org/0000-0003-0232-0211
Gieselmann, Astrid
Stieglbauer, Katharina
Galve, Milagros
Biedermann, Sarah
Gallinat, Jürgen
Schäfer, Ingo
Schmahl, Christian
Zähringer, Jenny
Roehle, Robert https://orcid.org/0000-0002-8130-6524
Sprünken, Erin D. https://orcid.org/0000-0002-9422-7788
Friede, Tim https://orcid.org/0000-0001-5347-7441
Gold, Stefan M. https://orcid.org/0000-0001-5188-4799
Maslahati, Tolou
Otte, Christian https://orcid.org/0000-0002-4051-997X
Koglin, Stefanie
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Funding
Funding for this research was provided by:
This was an investigator-initiated trial supported by an unrestricted grant from Bionorica SE, which also provided the study medication.
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Article History
Received: 31 January 2026
Accepted: 25 June 2026
First Online: 5 August 2026
Ethics
Competing interests: S.R. reports personal fees from Janssen, Otsuka, Bionorica SE (prior to signature of the study contract), Boehringer Ingelheim and Stillachhaus outside the submitted work, and grants from the German Research Foundation (DFG), the German Federal Ministry of Education and Research (BMBF), and the Innovation Fund. K.P. reports support from the Rahel Hirsch Program. K.M. reports grants from the German Research Foundation (DFG). J.G. reports research funding from the German Federal Ministry of Education and Research and the German Research Foundation (DFG), and speaker fees from Lilly and Boehringer Ingelheim. C.S. reports personal fees from Boehringer Ingelheim outside the submitted work and grants from the German Research Foundation (DFG). T.F. reports institutional grants from the German Research Foundation (DFG), the Federal Joint Committee (G-BA), the German Federal Ministry of Education and Research (BMBF), and the European Commission, and personal fees for statistical consultancies including data monitoring committees from Actimed Therapeutics, Apellis, argenx, Aslan, AstraZeneca, Bayer, BerlinHeals, Boehringer Ingelheim, Biogen, BiosenseWebster, Bristol Myers Squibb, Cardior, CSL Behring, CVRx, Daiichi Sankyo, eCovery, Enanta Pharmaceuticals, Fresenius Kabi, Galapagos, IQVIA, Johnson & Johnson, Novartis, PINK! Aktiv gegen Brustkrebs, PPD, Priothera, Recardio Inc, Recordati, Relaxera, Roche, Sarfez, UpstreamBio, Viatris Inc, VICO Therapeutics, and Vifor. S.M.G. reports honoraria from Hexal, Streamed-Up, Tegus, Angelini, Boehringer Ingelheim and KISO Health and research funding from DFG, the European Commission, Wellcome and the Congressionally Directed Medical Research Programs (CDMRP). C.O. reports honoraria for lectures and scientific advice from Boehringer Ingelheim, Eli Lilly, Janssen, Limes Klinikgruppe and Peak Profiling, and research funding from the German Research Foundation (OT 209/7-3, 14-1, 19-1, 21-1, EXC 2049), the European Commission (IMI2 859366), the German Federal Ministry of Education and Research (KS2017-067, 01KX2524), the Berlin Institute of Health (B3010350) and Wellcome (303746/Z/23/Z). S.K. reports personal fees from Boehringer Ingelheim outside the submitted work. The other authors declare no competing interests.
