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Article History

Received: 3 August 2025

Accepted: 25 September 2025

First Online: 10 October 2025

Declarations

:

: Norman B Gaylis reports personal fees from Arthritis and Rheumatic Disease Specialties, during the conduct of the study. Alan Kivitz is involved in a clinical research trial sponsored by Altoona Center for Clinical Research, during the conduct of the study; reports personal fees from AbbVie, Celgene, Horizon, Janssen, Merck, Genzyme, Regeneron, Sun Pharma Advanced Research, Boehringer Ingeleheim, and Flexion, personal fees, participation on an advisory committee or review panel, and stock ownership from Pfizer and Sanofi, personal and consultant fees, and stock ownership for Gilead, and stock ownership in Amgen and GlaxoSmithKline, outside of the submitted work. Melissa Evangelista reports personal fees and stock from SetPoint Medical, outside of the submitted work, and is an employee of SetPoint Medical. Yaakov A Levine reports personal fees and stock from SetPoint Medical, outside of the submitted work, and is an employee of SetPoint Medical. YAL also holds several patents around use of vagus nerve stimulation for inflammatory disease. David Chernoff reports personal fees, outside of the submitted work, and is an employee and stockholder at SetPoint Medical. David Sikes and Diane Lewis Horowitz declare no competing interests.

: This study complied with the Declaration of Helsinki and Good Clinical Practice Guidelines established by the International Conference on Harmonization. The institutional review board and independent ethics committees at each investigational center (Biomedical Research Alliance of NY and Western Copernicus Group) reviewed and approved the final protocol and informed consent documentation. All patients provided their written informed consent.