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Article History

Accepted: 26 September 2023

First Online: 29 November 2023

Declarations

:

: This study was funded by Boehringer Ingelheim (BI study numbers 1402-0005; NCT03904576). The funders of the study had a role in the study design, data analysis, data interpretation, and writing of the report.

: MG, RF, SRM, SJ and AW are employees of Boehringer Ingelheim Pharma GmbH & Co. KG. VS is an employee of Boehringer Ingelheim International GmbH. JdB is an employee of PRA Health Sciences. All authors did not receive any direct compensation relating to the development of the manuscript.

: To ensure independent interpretation of clinical study results, Boehringer Ingelheim grants all external authors access to all relevant material, including participant-level clinical study data, and relevant material as needed by them to fulfil their role and obligations as authors under the ICMJE criteria. Furthermore, clinical study documents (e.g., study report, study protocol, statistical analysis plan) and participant clinical study data are available to be shared after publication of the primary manuscript in a peer-reviewed journal and if regulatory activities are complete and other criteria met per the BI Policy on Transparency and Publication of Clinical Study Data: ExternalRef removed. Prior to providing access, documents will be examined, and, if necessary, redacted and the data will be de-identified, to protect the personal data of study participants and personnel, and to respect the boundaries of the informed consent of the study participants. Clinical Study Reports and Related Clinical Documents can also be requested via the link ExternalRef removed. All requests will be governed by a Document Sharing Agreement. Bona fide, qualified scientific and medical researchers may request access to de-identified, analyzable participant clinical study data with corresponding documentation describing the structure and content of the datasets. Upon approval, and governed by a Data Sharing Agreement, data are shared in a secured data-access system for a limited period of 1 year, which may be extended upon request. Researchers should use the ExternalRef removed link to request access to study data.

: The trial was carried out in compliance with the clinical trial protocol and approved by an independent ethics committee of the participating center. All procedures were conducted in accordance with the principles of the 1964 Declaration of Helsinki.

: Each volunteer signed and dated an informed consent form according to the local regulatory and legal requirements and Good Clinical Practices.

: Not applicable

: Not applicable

: MG, RF, SRM, SJ, VS, AW and JdB contributed to the study concept or design, and data analyses or interpretation. All authors contributed toward the preparation of the manuscript, approved the final submitted version, and agreed to be listed as authors.