Study approval.
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The protocol and all other trial-related materials were approved by the ethics committee of the promoting center (IRCCS Bambino Gesù Children’s Hospital) and by the Italian regulatory authority (Agenzia Italiana del Farmaco – AIFA and Istituto Superiore di Sanità commission for phase I studies) on July 10, 2018. Only 1 protocol amendment was submitted and approved, relating to the change in principal investigator from GR to PR in Bergamo. Written informed consent was obtained from all adults patients and by the parents or legal representatives for all pediatric patients before commencing study-specific procedures. All study procedures were performed in accordance with the Declaration of Helsinki, implementing good clinical and good medicinal practices.