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Article History

Received: 23 July 2025

Accepted: 12 June 2026

First Online: 29 July 2026

Declarations

Ethics approval and consent to participate: The trial was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines of the International Council for Harmonisation and applicable laws and regulations. The protocol was approved by a central institutional review board (Adarra Inc., Cincinnati, OH, USA; number IRB00000971), and the local institutional review board or ethics committee at each trial center oversaw the conduct and documentation of the trial. Written informed consent or assent (or both) was obtained from all the patients or their parent or legal guardian before enrollment.

Consent for publication: Not applicable.

Competing interests: MC reports consulting fees from Adare Pharma Solutions/Ellodi Pharmaceuticals, Allakos, Apogee, AstraZeneca, Bristol Myers Squibb, Uniquity Bio, Phathom Pharmaceuticals, Recludix Pharma, Regeneron Pharmaceuticals Inc., Sanofi, Shire/Takeda, and research funding from Adare Pharma Solutions/Ellodi Pharmaceuticals, Allakos, AstraZeneca, Celgene, Danone, Regeneron Pharmaceuticals Inc., Shire/Takeda. JMS reports consulting fees from Allakos, ARS Pharma, DBV Technologies, Merck, Novartis, Readysetfood, Regeneron Pharmaceuticals Inc., Sanofi, Shire/Takeda. SO served on advisory boards for C Celgene/Receptos/Bristol Myers Squibb, Medtronic, Ocean Pharma, Sanofi/Regeneron Pharmaceuticals Inc., and reports speaker fees from Medtronic, Sanofi/Regeneron Pharmaceuticlas Inc. ESD reports consulting fees from AbbVie, Adare/Ellodi, Akesobio, Alfasigma, ALK, Allakos, Amgen, Apogee, Apollo, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biocryst, Bryn, Calypso, Celgene/Receptos/Bristol Myers Squibb, Celldex, Dr. Falk Pharma, EsoCap, Eupraxia, Ferring, GI Reviewers, GSK, Holoclara, Invea, Knightpoint, LucidDx, Morphic, Nexstone Immunology/Uniquity, Nutricia, Parexel/Calyx, Phathom, Regeneron Pharmaceuticals Inc., Revolo, Robarts/Alimentiv, Sanofi, Shire/Takeda, Target RWE, Third Harmonic Bio, Upstream Bio, research funding from Adare/Ellodi, Allakos, Arena/Pfizer, AstraZeneca, Celgene/Receptos/Bristol Myers Squibb, Celldex, Eupraxia, Ferring, GSK, Meritage, Miraca, Nutricia, Regeneron Pharmaceuticals Inc., Revolo, Sanofi, Shire/Takeda, Uniquity, and educational grants from Allakos, Aqilion, Holoclara, Invea. DA reports consulting fees from Alexion Pharma, LaunchitDTx, Mirum Pharma, and speaker fees from Sanofi. MER reports consulting fees from AstraZeneca, Celgene, Celldex, ClostraBio, EnZen Therapeutics, GSK, Guidepoint, Pfizer, Pulm One, Regeneron Pharmaceuticals Inc., Sanofi, Serpin Pharma, Spoon Guru, Uniquity Bio, holds equity interest in Allakos, Celldex, ClostraBio, EnZen Therapeutics, Pulm One, Santa Ana Bio, Serpin Pharma, Spoon Guru, Uniquity Bio, receives royalties from PEESSv2 (Mapi Research Trust), reslizumab (Teva Pharmaceuticals), UpToDate, and is the inventor of patents owned by Cincinnati Children’s Hospital. RL, AR, and EM are employees and shareholders with Regeneron Pharmaceuticals Inc. ML and STT are employees and may hold stock and/or stock options with Sanofi.