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Article History

Accepted: 23 March 2025

First Online: 22 May 2025

Declarations

:

: All authors are employees of Bayer AG.

: Availability of the data underlying this publication will be determined according to Bayer’s commitment to the European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America principles for responsible clinical trial data sharing, pertaining to scope, time point, and process of data access. Bayer commits to sharing, upon request from qualified scientific and medical researchers, patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the USA and European Union as necessary for performing legitimate research. This commitment applies to data on new medicines and indications that have been approved by the European Union and US regulatory agencies on or after January 1, 2014. Interested researchers can use studydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to perform further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the study sponsors’ section of the portal. Access will be granted to anonymized patient-level data, protocols, and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.

: Not applicable.

: This study was funded by Bayer AG.

: 1. All authors made substantial contributions to the conception or design of the work and the acquisition, analysis, and interpretation of the data. 2. All authors drafted the manuscript or revised it critically for important intellectual content. 3. All authors provided final approval of the version to be published. 4. All authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

: The protocol and all protocol amendments for Studies 1 and 2 were reviewed and approved by the study site’s Independent Ethics Committee (Ethics Committee of the Bavarian State Medical Association, Munich, Germany) before the start of each study. The protocol and all protocol amendments for Study 3 were reviewed and approved by each of the two study sites’ Institutional Review Boards before the start of the study. All three studies met all local legal and regulatory requirements. They were conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice.

: All subjects provided written informed consent before any study-specific tests or procedures were carried out.

: Not applicable.