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Article History

Received: 12 February 2019

Accepted: 2 May 2019

First Online: 22 May 2019

Ethics approval and consent to participate

: The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Guidelines for Good Clinical Practice and local regulations. An institutional review board or independent ethics committee at each site approved the protocol, consent form and any other written information provided to patients or their legal representatives.

: All patients or their legal representatives gave written informed consent/assent prior to study entry as per local requirements of the participating centres.

: Gabriella Giancane has no conflicts of interest to disclose.Claudio Lavarello has no conflicts of interest to disclose.Angela Pistorio has no conflicts of interest to disclose.Sheila K. Oliveira has no conflicts of interest to disclose.Francesco Zulian has no conflicts of interest to disclose.Ruben Cuttica reports speaker bureau, consulting and Principal Investigator for Abbvie, BMS, Centocor, GSK, Lilly, Pfizer, Roche, Sanofi, UCB (< 10.000 USD each).Michel Fischbach has no conflicts of interest to disclose.Bo Magnusson has no conflicts of interest to disclose.Serena Pastore has no conflicts of interest to disclose.Roberto Marini has no conflicts of interest to disclose.Silvana Martino has no conflicts of interest to disclose.Anne Pagnier has no conflicts of interest to disclose.Christine Soler has no conflicts of interest to disclose.ValdaStaņēvicha has no conflicts of interest to disclose.Rebecca Ten Cate has no conflicts of interest to disclose.Yosef Uziel has received speaker’s bureaus or consulting fees from: AbbVie, Pfizer, Novartis (< 10.000 USD each).JelenaVojinovic has no conflicts of interest to disclose.Elena Fueri has no conflicts of interest to disclose.Angelo Ravelli has received speaker’s bureaus or consulting fees from: AbbVie, BMS, Pfizer,Hoffman LaRoche, Novartis, Centocor (< 10.000 USD each).Alberto Martini does not have any conflict of interest to declare since March 2016, when he became the Scientific Director of the Gaslini Institute because this role does not allow him to render private consultancy resulting in personal income. AM performed consultancy activities on behalf of the Gaslini Institute for AbbVie, Boehringer, Novartis, and R-Pharm (< 10.000 USD each).Nicolino Ruperto has received honoraria for consultancies or speaker bureaus (< 10.000 USD each) from the following pharmaceutical companies in the past 3 years: Ablynx, AbbVie, Astrazeneca-Medimmune, Biogen, Boehringer, Bristol Myers and Squibb, Eli-Lilly, EMD Serono, Glaxo Smith and Kline, Hoffmann-La Roche, Janssen, Merck, Novartis, Pfizer, R-Pharma, SanofiServier, Sinergie, Sobi and Takeda.The Gaslini Hospital, where NR works as full-time public employee, has received contributions (> 10.000 USD each) from the following industries in the last 3 years: BMS, Eli-Lilly, GlaxoSmithKline, F Hoffmann-La Roche, Janssen, Novartis, Pfizer, Sobi. This funding has been reinvested for the research activities of the hospital in a fully independent manner, without any commitment with third parties.

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