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Article History

Accepted: 6 February 2025

First Online: 13 February 2025

Declarations

:

: Allergan (prior to its acquisition by AbbVie) and/or AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication.

: Eric Mann and Gagan Sawhney are speakers for AbbVie. Jeffrey A. Kammer has no disclosures. Jella An has previously served as a consultant for AbbVie. Erica C. Werts, Vanessa Vera, Marcos Rivas, Hongxin Lai, Sadhana Sonparote, and E. Randy Craven are employees of AbbVie and may hold AbbVie stock.

: Institutional review board or independent ethics committee approval was obtained at each site before the study began, and the study was performed in compliance with Good Clinical Practice, the principles of the Declaration of Helsinki, and applicable laws and regulations (ClinicalTrials.gov registration number NCT04647214).

: All patients in this study provided written informed consent before undergoing any study-related procedure.

: Not applicable.

: 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), provided 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, and execution of a data sharing agreement. 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: .

: Not applicable.

: Study design: ECW, VV, MR, ERC; data collection: EM, JAK, GS, JA; statistical analysis: HL; data interpretation: EM, JAK, GS, JA, ECW, VV, MR, HL, SS, ERC; drafting, revisions, and approval of the manuscript: EM, JAK, GS, JA, ECW, VV, MR, HL, SS, ERC.