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Article History

Accepted: 29 July 2025

First Online: 4 September 2025

Declarations

:

: This trial was funded by Boehringer Ingelheim (BI trial number: 1346-0036; ClinicalTrials.gov identifier: NCT05613777). The sponsor was involved in the trial design and implementation, and data collection, analysis, interpretation, writing the trial report and reviewing this manuscript. All authors had final responsibility for the decision to submit for publication.

: YB is an employee of Staburo GmbH. MD, SM, CRF and YS are employees of Boehringer Ingelheim.

: To ensure independent interpretation of clinical study results and to enable authors to fulfil their role and obligations under the International Committee of Medical Journal Editors criteria, Boehringer Ingelheim grants all external authors access to clinical study data pertinent to the development of the publication. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data when it becomes available on  Vivli - Center for Global Clinical Research Data, and earliest after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete, and other criteria are met. Please visit Medical & Clinical Trials | Clinical Research | MyStudyWindow for further information.

: Before the start of the trial, all protocols and required documents were reviewed and approved by the independent ethics committee of the trial centre (Ethikkommission an der Technischen Universität Dresden, Dresden, Germany) and relevant local authorities (Bundesinstitut für Arzneimittel und Medizinprodukte, BfARM, Bonn, Germany); EU CT number: 2022-500050-42-00. The trial was carried out in compliance with the approved clinical trial protocol, in accordance with the principles of the Declaration of Helsinki and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice.

: All participants provided written informed consent.

: Not applicable.

: Not applicable.

: All authors are responsible for the work described in this article and meet International Committee of Medical Journal Editors authorship criteria. MD, SM and YS contributed to the conception and design of the trial. MD, YB, SM, CRF and YS contributed to the acquisition, analysis, or interpretation of data. All authors drafted the work or reviewed it critically for important intellectual content, gave final approval of the version to be published and agreed to be accountable for all aspects of the work.