Lupus Science & Medicine
Funding This work was supported by Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA. Competing interests SRPM and NMW were employees of Takeda Development Center Americas, Inc., each with stock ownership interests in Takeda at the time the study was conducted. VAN, CM, FH, DB and ETM are employees of Takeda Development Center Americas, Inc., each with stock ownership interest in Takeda. RAF is a research consultant for Takeda Development Center Americas, Inc. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. Patient consent for publication Not applicable. Ethics approval This study involves human participants and was approved by Advarra Institutional Review Board (Pro00029715), Western Institutional Review Board (2019P000259), Oklahoma Medical Research Foundation (OMRF) (19-10), UCSD Human Research Protections (Project # 190227), Partners Human Research Committee (Protocol # 2019P000964). Participants gave informed consent to participate in the study before taking part. Provenance and peer review Not commissioned; externally peer-reviewed. Data availability statement Data are available upon reasonable request. The datasets, including the redacted study protocol, redacted statistical analysis plan, and individual participants data supporting the results reported in this article, will be made available within three months from initial request, to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymisation. Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise. Open access This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/ licenses/by/4.0/. ORCID iDs Scott R P McDonnell http://orcid.org/0000-0003-3127-7101 Van Anh Nguyen http://orcid.org/0000-0003-1996-9340 Elena Tomaselli Muensterman http://orcid.org/0009-0007-8916-3680 Richard A Furie http://orcid.org/0000-0001-6712-1585
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McDonnell SRP, et al . Lupus Science & Medicine 2024; 11 :e001112. doi:10.1136/lupus-2023-001112
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