Document is current

Article History

Accepted: 27 November 2024

First Online: 28 January 2025

Declarations

:

: Sanofi was both the sponsor and funder of the study.

: Klaus G. Parhofer, Peter Bramlage, and Ursula Rauch-Kröhnert have received consultancy honoraria from Sanofi. The institution of Peter Bramlage has received an honorarium for drafting the study protocol and publication. Constanze Gries, Cornelia Harder, Christiane Look, and W. Dieter Paar are employees and shareholders of Sanofi.

: Ethical approval was obtained from participating centers before enrollment with the approval number EA4/154/21.

: Written and dated informed consent was obtained from every patient before enrollment in the study.

: Not applicable.

: The dataset utilized in this article are not publicly available and can be shared upon reasonable request to the corresponding author.

: Not applicable.

: Substantial contributions to the conception or design of the work: PB, CG, CL, WDP. Acquisition, analysis, or interpretation of data for the work: KGP, CH, URK. Drafting the work or reviewing: PB. Reviewing critically for important intellectual content: KGP, CH, CL, WDP, URK. Final approval of the version to be published: all authors. Agreement 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: all authors.