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Article History

Received: 26 July 2024

Accepted: 4 February 2025

First Online: 25 February 2025

Declarations

:

: The study was conducted in accordance with consensus ethical principles derived from international guidelines, including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines and applicable International Council for Harmonisation Good Clinical Practice Guidelines. The institutional review board or independent ethics committee at each study center reviewed and approved the protocol, protocol amendments, informed consent form, and any other relevant documents (see the Supplementary Appendix for details). All participants provided written informed consent to participate in the study. During routine blinded monitoring, prior to database lock, the sponsor suspected and identified non-compliance with good clinical practice at four sites comprising 219 patients. Patients from these sites were subsequently excluded from the modified full analysis set, as prespecified in the statistical analysis plan (see the Supplementary Appendix for details).

: Not applicable.

: SJD, HG, GPG, and PD are all employees of and shareholders in Regeneron Pharmaceuticals, Inc. who report having three patents pending with Regeneron Pharmaceuticals, Inc. SE, CE, TH, HEH, KCT, JC, YP, LB, NT, GM, and NB are all employees of and shareholders in Regeneron Pharmaceuticals, Inc. GV has served as a consultant for AbbVie, Celgene, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi/Regeneron, and UCB; and as an Investigator for AbbVie, Image Analysis, Bristol Myers Squibb, Janssen, Lilly, Merck, MLKCDT, Novartis, Pfizer, and Sanofi/Regeneron. TF owns equity in Clario, Inc, and has received grants or contracts from various pharmaceutical and biotechnology companies developing new drugs to treat osteoarthritis. JDD is an employee of and shareholder in Regeneron Pharmaceuticals, Inc. who reports having two patents pending with Regeneron Pharmaceuticals, Inc. SZ has no conflict of interest to disclose. MF is an employee of Teva Pharmaceuticals; has been funded by Teva Pharmaceuticals for travel and attendance at investigator meetings; and has received and holds stocks or stock options.