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Article History

Accepted: 17 November 2024

First Online: 21 December 2024

Declarations

:

: This study was funded by AbbVie, Inc. AbbVie contributed to the study design, research, and interpretation of data, and the writing, reviewing, and approving of the publication.

: RD, TA, JK, TA, and YP are employees of AbbVie and may hold AbbVie stock or stock options. AL is an employee of Chaim Sheba Medical Center and Samson Assuta Ashdod Medical Center, with consulting agreements with AbbVie, Takeda, Elli-Lilly, Celltrion, and Janssen.

: This study was conducted in compliance with the protocol, and in accordance with Good Clinical Practice guidelines and the ethical principles that have their origin in the Declaration of Helsinki. The protocol was approved by three institutional review boards (Advarra, 6100 Meriweather Drive, Columbia, MD 21044 on 19 December 2019; Ethik-Kommission des Landes Berlin, Landesamt für Gesundheit und Soziales, Berlin, Germany on 23 July 2020; and Helsinki Committee, Derech Sheba 2, 5265601, Ramat Gan, Israel on 16 September 2020).

: All participants provided written informed consent to participate in this study.

: 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), 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 US 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.”

: Not applicable.

: RD and YP wrote the manuscript, and all authors reviewed the manuscript. YP, RD, and JK designed the study. AL collected the clinical data. RD and TA performed the data analysis, and RD, YP, TA, JK, and TA interpreted the results. All authors have read and agreed to the published version of this manuscript.