Dreher, Michael
Heier, Hanna-Teresa
Kienle-Gogolok, Andrea
Röschmann-Doose, Kristina https://orcid.org/0000-0002-1375-2418
Simon, Jörg
Singhal, Ravi
Täschner, Heidrun
Thomsen, Jörn
Weimer, Joachim
Wittig, Thomas
Wonhas, Otto
Thinesse-Mallwitz, Manuela
Funding for this research was provided by:
G. Pohl-Boskamp
Article History
Received: 6 November 2024
Accepted: 10 December 2024
First Online: 15 January 2025
Declarations
:
: Michael Dreher received consulting fees and honoraria for lectures from GSK, Boehringer Ingelheim, Novartis, Astra Zeneca and Pohl-Boskamp. Kristina Röschmann-Doose, Jörn Thomsen, Thomas Wittig are employees of the sponsor of this RCT. Hanna-Teresa Heier, Andrea Kienle-Gogolok, Jörg Simon, Ravi Singhal, Heidrun Täschner, Joachim Weimer, Otto Wonhas, and Manuela Thinesse-Mallwitz declare that they have no conflict of interest.
: The study was approved by the German Competent Authority (Federal Institute for Drugs and Medical Devices [Bundesinstitut für Arzneimittel und Medizinprodukte]) and the relevant independent ethics committees (lead: Ethics Commission of the Bavarian Medical Chamber, Germany; approved 17 February, 2023, reference number EK 22116). The study was performed in accordance with the Helsinki Declaration of 1964, and its later amendments. All patients provided informed consent before participation in the study and for the use of anonymized data for scientific publication.