Roque, Helena https://orcid.org/0009-0008-9936-5865
Dun, Alexander Rieem
Cooper, Alexandra
Kienzle, Scarlette
Welby, Sarah
Wilke, Thomas
Song, Jie
Abé, Christoph
Funding for this research was provided by:
UCB (Sponsorship for this study was funded by UCB. Funding by UCB was in accordance with Good Publication Practice guidelines (http://www.ismpp.org/gpp3). UCB had a role in the study design, collection, analysis, interpretation of the data, manuscript review, the decision to submit the manuscript for publication. Publication of this article was contingent upon approval by UCB.)
Article History
Received: 10 February 2025
Accepted: 22 April 2025
First Online: 22 May 2025
Declarations
:
: Thomas Wilke worked for consultancies, including Cytel Inc., GIPAM, GmbH, which undertook projects sponsored by pharmaceutical companies such as UCB. Sarah Welby is currently employed by GlaxoSmithKline Vaccines. The positions and opinions presented in this article reflect the work Sarah carried out during her employment at UCB, when the study was conducted and are not intended to represent the views or scientific works of GlaxoSmithKline. She is an employee and shareholder of GlaxoSmithKline. She declares no financial or non-financial relationships and activities and no conflicts of interest. Jie Song is currently employed by West China Hospital, Sichuan University. The positions and opinions presented in this article reflect the work Jie carried out during her employment at UCB. She declares no competing interests. Alexander Rieem Dun is currently employed by Schain Research. The positions and opinions presented in the article reflect the work Alexander carried out during his employment at Quantify Research. He declares no competing interests. Helena Roque, Alexandra Cooper, Scarlette Kienzle, and Christoph Abé declare no competing interests.
: The study was conducted in accordance with the protocol, applicable regulations, and guidelines governing clinical study conduct and the ethical principles that have their origin in the Declaration of Helsinki. The independent ethics committee and institutional review board in Sweden, the Swedish Ethical Review Authority, approved the study protocol and related documents (approval number 2022-05312-01, October 31, 2022). The Swedish Ethical Review Board waived the requirement to obtain any informed consent for this analysis of existing administrative data. Due to the non-interventional, retrospective nature of the analyzed data and because the analysis involved an anonymized dataset, neither ethical review nor informed consent of the patients was required to obtain the German data, in accordance with German national legislation (§ 75 SGB X). As the responsible authority, the involved sickness fund (AOK PLUS) approved the use of the data for the purpose of this study.