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Article History

Received: 13 May 2025

Accepted: 12 November 2025

First Online: 18 December 2025

Declarations

:

: GM, PB, FDS, and ON are employees of Sanofi and may hold stocks and/or stock options in the company. ES was an employee of Sanofi at the time of the study. All authors were involved in the design, conduct, analysis, and interpretation of the study, which was funded by Sanofi. While this may be perceived as a potential professional interest, the authors affirm that the study was conducted with scientific rigor and transparency. The authors declare no personal relationships, beliefs, or other non-financial interests that could be perceived to have influenced the work reported in this manuscript.

: This study (EudraCT No. 2021–004533–36) was conducted in compliance with the Declaration of Helsinki (World Medical Association) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practices guidelines (ICH E6 R2). The study also conformed to the European and French regulatory requirements.

: All participants provided written informed consent before undergoing any study-related procedures.

: Not applicable.

: The data that support the findings of this study are not publicly available to protect the privacy and confidentiality of study participants. Data may be available from the corresponding author upon reasonable request.

: Not applicable.

: GM performed formal analyses and interpretation of results. ON performed the formal analyses. PB and FDS conducted the in vitro study assessments. VW carried out the bioanalytical assays. ES conceptualised the study and interpreted the results. HS served as the principal investigator of the study. GM and ES contributed to writing-review and editing of the manuscript. All authors reviewed the manuscript critically and approved the final version. All authors agreed to be accountable for all aspects of the work.