Ghirardo, Sergio http://orcid.org/0000-0002-6329-4208
Trevisan, Matteo
Ronfani, Luca http://orcid.org/0000-0001-5710-3914
Zanon, Davide http://orcid.org/0000-0003-1350-0509
Maestro, Alessandra
Barbieri, Francesca
De Nardi, Laura
Amaddeo, Alessandro http://orcid.org/0000-0003-2117-0781
Barbi, Egidio http://orcid.org/0000-0002-6343-846X
Cozzi, Giorgio http://orcid.org/0000-0002-6427-1366
Article History
Received: 28 August 2022
Revised: 28 November 2022
Accepted: 7 December 2022
First Online: 17 December 2022
Declarations
:
: The protocol was approved by the independent bioethics committee of IRCCS Burlo Garofolo of Trieste, Italy, and by the Italian pharmacological agency (AIFA), Eudract code: 2018–004057-25. It was recorded at ClinicalTrial.gov before the enrolment of the first participant, registration number NCT04133623.
: All the parents/guardians gave the consent to participate on a dedicated written form; all the children gave their consent as well on written consent forms that were designed to be appropriate for patients aged 8–12 years and 12–18 years.
: All the authors gave the consent for the publication of the article in its current form.
: The authors declare no competing interests.
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