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Article History

Received: 8 March 2024

Accepted: 4 July 2024

First Online: 17 September 2024

Declarations

:

: Before patients participated in this study, the study protocol, final informed consent form, any promotional material/advertisements, and any other written information were reviewed and approved/given favorable opinion by the associated regional Ethics Committee and applicable regulatory authorities for each study site. The Investigational Brochure was provided for review. Written informed consent (patient’s parent or the legally authorized representative) and assent of the patient was a mandatory requirement for taking part in the study. Any patient could voluntarily withdraw consent for continued participation and data collection. The regional and local Ethics Committees providing approval were the Ethics Committee of the FN Brno/Local Ethic Committee FN Motol (Czechia), the Regional Ethics Committee for Region Hovedstaden (Denmark), the Committee for the Protection of Persons Sud Est III (France), the National Ethics Committee (Greece), Ethics Committee of the National Institute of Child Diseases/Ethics Committee of the Martin University Hospital (Slovakia), the Swedish Ethical Review Authority (Sweden), the North West - Greater Manchester Central Research Ethics Committee (United Kingdom), and the Medical Research Council Ethics Committee for Clinical Pharmacology (Hungary).

: All patients, parents, or caregivers provided consent for publication as part of the informed consent forms signed before inclusion in the study.

: PC has received speaker honoraria from Ewopharma and Takeda. MR and HS have nothing to disclose. MJ has received honoraria, consultancy, and speaker fees from ALK, CSL Behring, Ewopharma, GSK, Novartis, Sanofi-Genzyme, Stallergenes Greer, and Takeda, and has served as a principal investigator for trials sponsored by BioCryst, Octapharma, Pharming, and Takeda. GK has received support from Baxter/Baxalta/Shire/Takeda, Biotest, CSL Behring, Grifols, Kedrion, LFB, MSD, Novartis, Octapharma, and Sanofi for projects, advisory boards, symposia, clinical studies, and trials. NB has received honoraria from Baxalta/Shire/Takeda, BioCryst, and Octapharma for advisory boards, trials, and speaker fees. SJ has received support from Binding Site, Biotest, BPL, CSL Behring, Grifols, GSK, LFB, Octapharma, Pharming, Sanofi, Sobi, Takeda, UCB Pharma, Weatherden, and Zarodex for projects, advisory boards, meetings, studies, symposia, and clinical trials. CA is an employee of Takeda Development Center Americas, Inc. and a Takeda shareholder. KF and BM are employees and shareholders of Baxalta Innovations GmbH, a Takeda company. SSK was an employee of Takeda Development Center Americas, Inc. and a Takeda shareholder at the time of the study. LY is a Takeda shareholder, and was an employee of Takeda Development Center Americas, Inc. at the time of the study.