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Article History

Accepted: 29 April 2025

First Online: 23 May 2025

Declarations

:

: This study was sponsored by Hexal AG (a Sandoz company). The sponsor had a role in the design and conduct of the study presented herein. The open access fee for this paper was sponsored by Hexal AG (a Sandoz company). All authors had a role in the analysis and interpretation of the data and statistical analysis, preparation, review, approval of the manuscript, and decision to submit the manuscript for publication

: All authors have received personal compensation for serving as employees of Hexal AG (a Sandoz company).

: The datasets supporting the conclusions of this article are available from the corresponding author upon reasonable request.

: The study (Clinical Trial Registration: EudraCT no. 2019–001651–39) was conducted in accordance with the ethical principles of the Declaration of Helsinki and with the ICH E6 Guideline for Good Clinical Practice. The study was reviewed and approved by the Ethics Committee of the Land Berlin, Berlin, Germany.

: All participants or their legally authorized representatives signed statements of informed consent before enrollment and reconsented during the trials.

: Not applicable.

: Not applicable (no software or custom code).

: S.R., C.S., and J.P. were involved in the conception and design of the study. A.V.I.,M.R., F.R., and K.R. performed all analyses. All authors contributed to data interpretation. The first draft of the manuscript was written by Sandra Ribes, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.