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Article History

Received: 9 January 2024

Accepted: 22 January 2025

First Online: 14 March 2025

Declarations

:

: This study was conducted in accordance with the principles and guidelines described in the study protocol, the International Council for Harmonisation Guideline for Good Clinical Practice E6 (ICH GCP R2, November 2016), Title 21 of the US Code of Federal Regulations, the European Union (EU) Directives 2001/20/EC and 2005/28/EC, the Declaration of Helsinki, and applicable national and local regulatory requirements.

: Written informed consent and assent of the study participant (and parent or the participant’s legally authorized representative) was a mandatory requirement for taking part in the study.

: NCP receives research funds from CSL Behring and the Takeda group of companies, and is on the Speakers Bureau for CSL Behring, Horizon Therapeutics, and the Takeda group of companies.JEW reports grant/research/clinical trial support from ADMA Biologics, Chiesi, Janssen, Mustang Bio, Octapharma, and the Takeda group of companies; has served as a consultant/on advisory boards for ADMA Biologics, CSL Behring, Enzyvant, Grifols, Octapharma, Pharming, Regeneron, the Takeda group of companies, and X4 Pharmaceuticals; and participates on the Speakers Bureau for Pharming and for the Takeda group of companies.RLW reports grants and personal fees from ADMA Biologics, CSL Behring, Evolve Biologics, GC Biopharma (formerly Korean Green Cross), Grifols, and the Takeda group of companies; and reports grants from Kedrion Biopharma, Korean Green Cross, and Octapharma.AR, SK, and MWS have nothing to disclose.EG and ZL are employees of Takeda Development Center Americas, Inc. and are Takeda shareholders.SR-S and BM are employees of Baxalta Innovations GmbH, a Takeda company, and are Takeda shareholders.SS-K was an employee of Takeda Development Center Americas, Inc. and was a Takeda shareholder.LY was an employee of Takeda Development Center Americas, Inc. and is a Takeda shareholder.