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Article History

Received: 9 August 2023

Accepted: 12 January 2024

First Online: 12 February 2024

Declarations

:

: Joshua F. Baker has received consulting fees from CorEvitas and Cumberland Pharma and has received funding from Horizon Pharma. Denise Bennett, Miao Yu, Yolanda Munoz Maldonado, and Robert R. McLean are employees of CorEvitas (previously Corrona, LLC). Mira Ali and Patrick Zueger are employees of AbbVie Inc. and may own stock.

: The study was performed in accordance with the Declaration of Helsinki and the Guidelines for Good Pharmacoepidemiology Practice (GPP). All participating investigators were required to obtain full board approval for conducting noninterventional research involving human subjects with a limited dataset. Sponsor approval and continuing review was obtained through a central institutional review board (IRB), the New England Independent Review Board (NEIRB; no. 120160610). For academic investigative sites that did not receive authorization to use the central IRB, full board approval was obtained from their respective governing IRBs, and documentation of approval was submitted to CorEvitas, LLC before the site’s participation and initiation of any study procedures. All patients in the registry were required to provide written informed consent and authorization before participating. Note: Each registry has its own number. For example, the PsO registry uses (IntegReview, Protocol number is Corrona-PSO-500).