DuBrock, Hilary M.
Germack, Hayley D.
Gauthier-Loiselle, Marjolaine
Linder, Jörg
Satija, Ambika
Manceur, Ameur M.
Cloutier, Martin
Lefebvre, Patrick
Panjabi, Sumeet
Frantz, Robert P.
Funding for this research was provided by:
Janssen Scientific Affairs
Article History
Accepted: 2 November 2023
First Online: 18 November 2023
Declarations
:
: This study was funded by Janssen Scientific Affairs, LLC. The study sponsor was involved in several aspects of the research, including the study design, interpretation of data, writing of the manuscript, and decision to submit the manuscript for publication.
: Medical writing assistance was provided by professional medical writer, Mona Lisa Chanda, PhD, an employee of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript.
: HDG and SP were employees of Janssen Scientific Affairs, LLC at the time of the study conduct (now Johnson and Johnson Innovative Medicines) and may own stock/stock options. JL is an employee of Janssen-Cilag GmbH and may own stock/stock options. MGL, AS, AMM, MC, and PL are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs, LLC, which funded the development and conduct of this study and manuscript. HMD has received research grants from Bayer Pharmaceuticals, consultancy fees from Janssen, Pharmaceutical Companies of Johnson & Johnson, and has served on advisory boards for Janssen Pharmaceutical Companies of Johnson & Johnson and United Therapeutics. RPF is scientific medical advisor to Altavant, ShouTi, Liquidia Technologies, Merck, Tenax Pharmaceuticals, and Janssen Pharmaceutical Companies of Johnson & Johnson and has received consultancy fees from Janssen Pharmaceutical Companies of Johnson & Johnson, Gossamer Bio, Merck, Tenax, Insmed, and is on DSMB for Aerovate. His institution has received funding from Bayer and Gossamer Bio.
: This study was conceptualized and designed by HDG, SP, MGL, AS, AMM, MC, and PL. Data analysis and interpretation were performed by HMD, HDG, SP, JL, MGL, AS, AMM, MC, PL, and RPF. All authors have made substantial contributions to the drafting of the manuscript and have revised it critically for important intellectual content. All authors have provided final approval of this version to be published and agree to be accountable for all aspects of the work.
: The datasets generated during and/or analyzed during the current study are not publicly available due to third-party restrictions. The data that support the findings of this study are available from Optum<sup>®</sup>. Restrictions apply to the availability of these data, which were used under license for this study. However, data could be available from the corresponding author on reasonable request, provided that permission has been granted by Optum<sup>®</sup>.
: All analyses were conducted using SAS Enterprise Guide 7.1 (SAS Institute, Cary, NC, USA). The SAS programs are proprietary materials of Analysis Group, Inc.; therefore, restrictions apply to the access of these codes, which cannot be made available publicly.
: This observational study was conducted using de-identified, commercially available data from a secondary health care database that complies with the requirements of the HIPAA of 1996. Therefore, ethics approval and consent to participate are not applicable for the current study per Title 45 of Code of Federal Regulation, Part 46.101(b)(4) (ExternalRef removed). All methods were carried out in accordance with relevant guidelines and regulations, including the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.
: N/A.