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Article History

Accepted: 25 November 2024

First Online: 24 December 2024

Declarations

:

: This study was sponsored by NeRRe Therapeutics Ltd. (Stevenage, UK).

: Marcus-Hillert Schultze-Mosgau, Klaus Francke, Antje Rottmann, and Simone Schulz are employees of Bayer AG, Anna Engelen was an employee of Bayer AG at the time of conducting the study and data evaluation and is now an employee of Boehringer Ingelheim (Germany), Nand Singh is an employee of Quotient Science (Nottingham, UK), Steve Pawsey is an employee of NeRRe Therapeutics Ltd. (Stevenage, UK), and Ruth Lock is a consultant to NeRRe Therapeutics Ltd. and an employee of Aucuba Sciences Ltd (London, UK).

: All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Approval from the Research Ethics Committee was received on 14 September 2020 (IRAS ID: 285216).

: Informed consent was obtained from all individual participants included in the study.

: Not applicable.

: Result summaries of Bayer's sponsored clinical trials in drug development phases 1, 2, 3, and 4 are provided in the Bayer Trial Finder application after marketing authorization approval in line with the position of the global pharmaceutical industry associations laid down in the "Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases". In addition, results of clinical drug trials will be provided on the publicly funded website and EU Clinical Trials Register in line with the applicable regulations. 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 for medicines and indications approved in the United States (US) and European Union (EU) on or after January 01, 2014, as necessary for conducting legitimate research.

: Not applicable.

: Participated in research design: Anna Engelen, Steve Pawsey, Ruth Lock, Simone I. Schulz, Nand Singh, Antje Rottmann, Marcus-Hillert Schultze-Mosgau. Conducted experiments: Anna Engelen, Steve Pawsey, Simone I. Schulz, Nand Singh. Contributed new reagents or analytic tools: Simone I. Schulz, Anna Engelen. Performed data analysis: Anna Engelen, Steve Pawsey, Simone I. Schulz, Nand Singh, Klaus Francke, Antje Rottmann, Marcus-Hillert Schultze-Mosgau. Wrote or contributed to the writing of the manuscript: all authors.