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Article History

Received: 14 February 2024

Accepted: 12 November 2024

First Online: 30 December 2024

Declarations

:

: This study involved secondary analysis of existing de-identified data. As such, the analysis does not constitute human subjects research according to US federal regulations as defined at 45 CFR part 46, Subpart A (2018 Requirements), and thus did not require Independent Ethics Committee/Institutional Review Board review/approval or consent to participate. For ADMIRE CD, the study was conducted in accordance with the 2008 Declaration of Helsinki and all relevant international, national, and local rules and regulations. The protocol was approved by the local ethics committee of participating centers. All patients gave written informed consent before enrollment (if required by local regulations). Patients included in the INSPECT study had previously been enrolled in the ADMIRE-CD trial and had already provided informed consent. For PREFACE, the study was conducted in accordance with the Declaration of Helsinki, Good Pharmacoepidemiology Practices (GPP), ISPE GPP guideline, and any local regulations. Approvals were obtained from relevant Independent Ethics Committees and Institutional Review Boards according to local requirements.

: Not applicable.

: Chitra Karki is an employee and shareholder of Takeda Pharmaceuticals. Gary Hantsbarger was an employee and shareholder of Takeda Pharmaceuticals at the time of the study. Elisabetta Fenu, Ken Genenz, and Inmaculada Gilberte were employees of Takeda Pharmaceuticals at the time of the study. Ken Genenz is a shareholder of Takeda Pharmaceuticals. Erika Turkstra is an employee of Parexel International. Parexel received funding from Takeda for the completion of this study. Julián Panés reports grants from AbbVie and Pfizer Inc.; consultancy fees/honorarium from AbbVie, Arena, Athos, Boehringer Ingelheim, Celgene, Galapagos, Genentech/Roche, GSK plc, Janssen, Mirum Pharmaceuticals, Morphic Therapeutic, Nestlé, Origo Pharmaceuticals, Pandion Therapeutics, Pfizer Inc., Progenity, Protagonist, Takeda Pharmaceuticals, Theravance Biopharma, and Wasserman; support for travel to meetings from AbbVie and Takeda Pharmaceuticals during the conduct of the study; payment for lectures including service on speaker bureau from Abbott, Janssen, Pfizer Inc., and Takeda Pharmaceuticals; and payment for development of educational presentations from Abbott, Janssen, Pfizer Inc., and Roche.