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Article History

Accepted: 26 September 2024

First Online: 4 November 2024

Declarations

:

: The study was funded by CSL Behring, 1020 First Ave, King of Prussia, PA, USA.

: The following are the conflicts of interest for each respective author: Alexandra Starry and Nils Picker participated in this study as staff members of Cytel; the work of Cytel in this study was financed by CSL Behring, 1020 First Ave, King of Prussia, PA, USA. Axel Dittmar has no other conflicts of interest to declare than the ones related to the affiliation. Ulf Maywald has no other conflicts of interest to declare than the ones related to the affiliation. Stefan G. Spitzer received honoraria for lectures from Medtronic, Abbott, Daiichi Sankyo, Edwards, AstraZeneca, Bayer Vital, Bristol Myer Squibb/Pfizer, Boehringer Ingelheim, Biotronik, and Amgen; received honoraria for advisory board activities from Ingress health; and participated in clinical trials with Abbott, Medtronic, and Ablacon. Jonathan Galduf is an employee of CSL Behring.

: The primary data source for this study was claims data obtained from AOK PLUS. Due to privacy, contractual obligations, and local data protection laws, both the raw claims data and anonymized derived datasets cannot be publicly shared. However, we are committed to data transparency and have taken steps to ensure the reproducibility of our findings by providing detailed methodology, including statistical models and analytical techniques within the text and supplemental material.

: This study used the data under the formal agreement and legal basis of §75, Tenth Book of the Social Code and in accordance with the World Medical Association's Declaration of Helsinki []. Therefore, informed consent and ethics approval from an institutional review board were not required for this retrospective study because the secondary dataset was anonymized, non-identifiable, and non-interventional, ensuring participant privacy and upholding the ethical principles outlined in the Declaration.

: Not applicable.

: Not applicable.

: The code is generally considered proprietary and may not be publicly shared. However, upon request, Cytel may be able to provide access to specific components of the code.

: A.S. and S.S. designed the study and protocol, and U.M. provided constructive feedback and comments from a technical perspective. A.S. and A.D. conducted the data analysis. N.P. provided scientific support on the methodology. All other authors assisted in interpreting the findings. A.S. took the lead in writing the manuscript, with the guidance of N.P. All authors provided critical feedback and helped shape the research, analysis, and manuscript.