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CR has received compensation as a scientific consultant and as a speaker in sponsored symposia from Jazz Pharmaceuticals, Servier, Amgen, Clinigen, and SERB Pharmaceuticals. RP has participated in advisory board meetings for Amgen, Novartis, Clinigen, and Jazz and has received honoraria from Amgen for participating in the speaker\u2019s bureau. CP reports research funding from Amgen, Neovii, Jazz, Medac, and Riemser. LV has received research funding from Merck Sharpe and Co, travel and accommodation expenses from Amgen and Takeda, and has been a member of the speaker\u2019s bureau for Amgen and Takeda. MH and GZ are employees of Amgen Inc. GZ has patents 20190300609 and 20130323247 licensed. AvS has received honoraria from and has been member of the speaker bureau for Amgen and Novartis and has participated in an advisory board for Amgen, Jazz-Pharmaceuticals, and Clinigen. The remaining authors have declared that they have no conflicts of interest to disclose.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"The study was performed in accordance with the Declaration of Helsinki. The trial protocol received approval from each center\u2019s ethics committee\/institutional review board (Supplementary Table\u00a0\n                      \n                      ). Written informed consent was provided by patients\u2019 parents or legal guardians.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}}]}}