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Article History

Received: 24 March 2025

Accepted: 1 February 2026

First Online: 28 March 2026

Declarations

:

: This study was funded by Boehringer Ingelheim (BI study number: 1346-0047; ClinicalTrials.gov identifier: NCT05718843 and BI study number: 1346-0048; ClinicalTrials.gov identifier: NCT05731895).

: Study 1346-0047 and Study 1346-0048 are Boehringer Ingelheim-sponsored studies. The sponsor was involved in study design and implementation, as well as data collection, analysis, interpretation, writing the study report and reviewing this manuscript. All authors had final responsibility for the decision to submit for publication.

: All authors are responsible for the work described in this article and meet International Committee of Medical Journal Editors (ICMJE) authorship criteria. Conception and design of the study: HC, NW, KH, SM and MD. Acquisition, analysis, or interpretation of data: HC, NW, KH, SM and MD. 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.

: HC, SM, BAE are employees of Boehringer Ingelheim Pharmaceuticals, Inc. ED, KH, YS, NW and MD are employees of Boehringer Ingelheim Pharma GmbH & Co. KG. AH is an employee of Clinical Research Services, which has been contracted by Boehringer Ingelheim as CRO for the conduct of this study and has received financial support for its services.

: Study 1346-0047: Ethics Committee of the Schleswig-Holstein Medical Association, approved on 19 December 2022 (approval letter no. 135/22 II, issued 20 December 2022). Study 1346-0048: Ethics Committee of the Schleswig-Holstein Medical Association, approved on 23 January 2023 (approval letter no. 001/23 II, issued 25 January 2023).

: All participants provided written, informed consent prior to study entry.

: Not applicable.

: To ensure independent interpretation of clinical study results and enable authors to fulfil their role and obligations under the ICMJE 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.

: Not applicable.