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Article History

Received: 3 September 2025

Revised: 4 November 2025

Accepted: 6 December 2025

First Online: 18 December 2025

Declarations

:

: Compliance with ethical standards in this trial, including the Declaration of Helsinki, was previously reported by Schaefer et al.: Eur J Pediatr 2019;178:1013–21. Written informed consent was obtained from a parent/guardian or legally acceptable representative, and the trial participants provided age-appropriate informed assent. The study was authorized by the Independent Ethics Committee of UZ Leuven (Leuven, Belgium), the institution of the Coordinating Investigator, and by those of the participating institutions at each study site.

: SES and KS are employees of Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, MD, United States.