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Article History

Received: 19 November 2018

Accepted: 9 May 2019

First Online: 23 May 2019

Ethics approval and consent to participate

: The study was approved by the relevant regulatory bodies of each country and institution. It was conducted in accordance with the Declaration of Helsinki and the Good Clinical Practices. All patients or their parents/caregivers provided written consent for participation in the study.

: Not applicable.

: I. Foeldvari has served on advisory boards with AbbVie, Novartis, Chugai, and Genzyme.T. Constantin has received speaker’s fees from or served as a consultant for AbbVie, Novartis, Pfizer, and Roche.J. Vojinović has received honoraria from AbbVie, Pfizer, TEVA, MSD, and Roche.G. Horneff has received honoraria from Chugai, UCB, Pfizer, AbbVie, Roche, and Novartis.J. Dehoorne has received speaker’s fees from or served as a consultant for AbbVie, Pfizer, and Roche.V. Stanevicha has received consulting fees from AbbVie and Roche and has a partnership with Pfizer.I. Nikishina has received honoraria from AbbVie, Bristol-Myers Squibb, Janssen, MSD, Novartis, Pfizer, and Roche.P. Doležalová has received speaker’s bureau honoraria from Pfizer, AbbVie, Novartis, Hoffman-La Roche, Medac, Swedish Orphan Biovitrum, Eli Lilly, Sanofi, and Genzyme.R. Pedersen and B. Vlahos are employees of Pfizer, the sponsor of this study, and own company stock.J. Bukowski is a former employee of Pfizer, the sponsor of this study, and may own company stock.A. Martini has received speaker’s bureau and honoraria from Abbott, AbbVie, Amgen, Biogen Idec, Bristol-Myers Squibb, Astellas, Boehringer, Italfarmaco, Janssen, MedImmune, Novartis, Novo Nordisk, Pfizer, Sanofi, Roche, Servier, and Takeda.N. Ruperto has received speaker’s bureau and honoraria from Abbott, AbbVie, Amgen, Biogen Idec, Astellas, Alter, AstraZeneca, Boehringer, Bristol-Myers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, Servier, Takeda, and Vertex.The IRCCS Istituto Giannina Gaslini, which is the public hospital where Dr. Ruperto and Prof Martini work as full-time employees, has received contributions to support the research activities of the network of PRINTO () from Abbott, Bristol-Myers Squibb, Francesco Angelini SPA, Glaxo SmithKline, Janssen Biotech Inc., Novartis, Pfizer Inc., Roche, Sanofi Aventis, and Schwarz Biosciences GmbH; this money has been reinvested for the research activities of the hospital in a fully independent manner without any commitment to third parties.V. Chasnyk, V. Panaviene, G. Sušić, K. Kobusinska, Z. Zuber, B. Dobrzyniecka, B. Bader-Meunier, L. Breda, C. Job-Deslandre, I. Rumba-Rozenfelde, and N. Wulffraat declare that they have no competing interests.

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