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Article History

Received: 27 December 2024

Accepted: 23 June 2025

First Online: 25 July 2025

Declarations

:

: The research protocol for the database was reviewed by Advarra IRB (IRB#00000971). The IRB determined this research project to be exempt. This study adhered to the tenets of the Declaration of Helsinki. The database used for this study is fully de-identified and compliant with the Health Insurance Portability and Accountability Act (HIPAA). A description of the database was submitted and determined to be exempt by Advarra CIRBI. This study involved retrospective, observational real-world data that is de-identified/anonymized; obtaining informed consent from individual patients is not required. This study was conducted in compliance with the US FDA Title 21 Code of Federal Regulations (CFR) Part 50 – Protection of Human Patients and Part 56 – Institutional Review Boards; the International Council for Harmonisation for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines E6R2 (November 09, 2016) as they apply to post-marketing, observational studies; the Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the International Society for Pharmacoepidemiology (ISPE); the Belmont Report; US Title 45 CFR Part 164 Subpart E – Privacy of Individually Identifiable Health Information and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule (2002). This study adhered to the tenets of the Declaration of Helsinki.

: Not applicable.

: Not applicable.

: This study was supported by Johnson & Johnson. Hrishikesh Kale, Tiina Drissen, and Nilanjana Dwibedi are employees of Johnson & Johnson.Andrew J Cutler is a consultant for Johnson & Johnson.Stevan Geoffrey Severtson, Becca S Feldman and Carl D Marci are employees of OM1 which received funding from Johnson & Johnson to conduct this study.