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Article History

Received: 13 May 2025

Accepted: 18 August 2025

First Online: 12 November 2025

Declarations

:

: AbbVie funded these studies and participated in the trial design, research, analysis, data collection and interpretation, and the publication’s review and approval. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.

: Louisa Schlachter, Sven Stodtmann, and Ramesh R. Boinpally are AbbVie employees and may hold AbbVie stock or options. Alexander Voelkner, Fredrik Jonsson, and Hendrik Maxime Lagraauw are employees of qPharmetra LLC.

: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent, scientific research, and will be provided following review and approval of a research proposal, statistical analysis plan (SAP), and execution of a data sharing agreement (DSA). Data requests can be submitted at any time after approval in the USA and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: , then select “Home.”

: The studies reported herein were conducted in accordance with the International Council for Harmonisation (ICH) guidelines, applicable regulations, and guidelines governing clinical study conduct and the ethical principles that have their origin in the Declaration of Helsinki. Approval was granted by institutional review boards and independent ethics committees at participating institutions.

: All participants provided written consent prior to participation or study-related procedures.

: All individual participants signed informed consent regarding publishing their data.

: Not applicable.

: Conceptualization: L.S., S.S., and R.R.B. Data curation, formal analysis, methodology, and visualization: all authors. Writing—original draft: L.S. All authors critically reviewed and edited drafts of this manuscript and approved the final draft for publication.