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Article History

Received: 19 May 2025

Accepted: 26 October 2025

First Online: 12 February 2026

Declarations

:

: Institutional Review Board or Ethics Committee approval was obtained before recruitment and data collection for each site or country (both central and local ethics committee approval was required in Brazil, Croatia and Germany). This study was conducted in accordance with the protocol, the Declaration of Helsinki, Good Pharmacoepidemiology Practices, International Society of Pharmacoepidemiology guidelines for Good Pharmacoepidemiology Practices, and local regulations. All participants provided informed consent before recruitment and data collection.

: Not applicable.

: MW and AS are employees of Takeda Development Center Americas, Inc. and hold stock/options in Takeda Pharmaceutical Company Limited. IMS has received research funding support and/or speaker/consultant fees from BioCryst, CSL Behring, KalVista Pharmaceuticals, Octapharma, Pharming, Pharvaris and Takeda/Shire. RM and MDLC are employees of ICON, which was contracted by Takeda to perform this study. RZ reports being a speaker for CSL Behring, Novartis, Pint Pharma, Sanofi, and Takeda; an advisor for AbbVie, CSL Behring, KalVista Pharmaceuticals, Pint Pharma, and Takeda; and a researcher for Sanofi and Takeda. MS was contracted by Takeda to conduct this study. ASG has received speaker/consultancy fees from Astra Zeneca, Astria, Catalyst, CSL Behring, KalVista Pharmaceuticals, Multicare Pharma, Pharvaris, Pint Pharma, and Takeda; a scholarship from Brazilian Council of Research (CNPq); and a grant of researcher initiative from Takeda.