Ethical Approval
This study was carried out in accordance with the Declaration of
Helsinki and approved by the local MRB of all study centers; the Medical
Ethics Committee of the University Medical Center Utrecht, Utrecht, the
Netherlands (NL55788.041.15); the ethics committee of University
Regensburg, Germany (18–1034–101); Clinical Research Ethics Committee
of the Basque Country, Spain (PI2015075 (SO)); National Medical Ethics
Committee, Slovenia (0120–569/2017/4)). The SysPharmPediA study was
registered at Clinicaltrials.gov with the identifier of NCT04865575. All
participants/parents gave their informed consent.