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Article History

Received: 18 October 2019

Accepted: 24 August 2020

First Online: 10 September 2020

Ethics approval and consent to participate

: Both trials included in this manuscript were conducted in accordance with the Declaration of Helsinki and good clinical practice and were approved by local institutional review boards or independent ethics committees at each center. Parents or guardians provided written informed consent, and patients provided written informed assent according to national requirements.

: Not applicable

: CM has received consulting fees (< $10,000) from AbbVie.NR has received honoraria for consultancies or speaker bureaus (< $10,000) from the following in the past 2 years: Ablynx, AbbVie, Boehringer, Bristol-Myers Squibb, Eli Lilly, EMD Serono, F. Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, Rewind, R-Pharma, Sanofi, Servier, Sinergie, and Takeda. The Gaslini Hospital, where NR works as a full-time public employee, has received contributions (> $10,000) from the following industries in the last 2 years: Abbott, Bristol-Myers Squibb, The Angelini Group “Francesco Angelini,” GlaxoSmithKline, F. Hoffmann-La Roche, Italfarmaco, Janssen, Novartis, Pfizer, Sanofi Aventis, Schwarz Biosciences, Sobi, Xoma, and Wyeth. This funding has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties.SP, EP, AP, BF, SG, and GG declare no competing interests.CWouters declares unrestricted research grants to her institution from GlaxoSmithKline, Pfizer, and Roche.PD has received speaker or consultant fees from AbbVie, Novartis, Pfizer, F. Hoffmann-La Roche, Medac, Eli Lilly, Sanofi, and Merck Sharp & Dohme (< $10,000).CWells is an employee of Roche Products Ltd.WD is an employee of and owns stock in Roche Products Ltd.HIB has received consulting fees (< $10,000) from Pfizer, EMD Serono, and AstraZeneca and (> $10,000) from Bristol-Myers Squibb and Janssen and research grants from Bristol-Myers Squibb and Pfizer.FDB has received consulting fees (< $10,000) from F. Hoffmann-La Roche and an unrestricted research grant from F. Hoffmann-La Roche.AR has received consulting fees (< $10,000) from AbbVie, Bristol-Myers Squibb, Pfizer, F. Hoffmann-La Roche, Novartis, Centocor, Francesco Angelini, and Reckitt Benckiser.