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Article History

Received: 4 March 2024

Accepted: 30 September 2024

First Online: 30 October 2024

Declarations

:

: The trial protocol was approved by an ethics review board at the University of Pittsburgh School of Medicine. All participants will provide written informed consent prior to entering the study.

: Not applicable.

: RA reports grants from Boehringer Ingelheim, Bristol Myers Squibb, EMD Serono, Janssen, Mallinckrodt, Pfizer, Q32; consulting fees from ActiGraph, Alexion, ANI, Argenx, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Cabaletta Bio, Capella, Corbus, CSL Behring, EMD Serono, Galapagos, Horizon Therapeutics, I-Cell, Lilly, Janssen, Kezar, Kyverna, Mallinckrodt, Merck, Octapharma, Pfizer, Roivant, Sanofi, Teva. CVO reports grants from Abcuro, Alexion, Argenx, CSL Behring, EMD Serono and has served on advisory boards for Cabaletta and Pfizer and Data Safety and Monitoring Boards for the trial “Autologous Stem Cell Transplantation with CD34-Selected Peripheral Blood Stem Cells in Patients with Treatment Resistant Systemic Sclerosis” and for “Reducing Inflammation for Greater Health Trial: The RIGHT Study”. DIS reports grants from Boehringer Ingelheim and the National Heart, Lung, and Blood Institute (NHLBI) and holds stock in Amgen, Lilly, Johnson & Johnson, Merck. SM-K, DS and DCK have nothing to disclose. DJK reports grants from Boehringer Ingelheim, the US Department of Defense, and the National Institutes of Health. PL and ALO are employees of Boehringer Ingelheim Pharmaceuticals, Inc. CSC was an employee of Boehringer Ingelheim Pharmaceuticals, Inc. when this study was designed and this manuscript was developed.