The study will be performed following the protocol registered before the commencement of screening. However, in case of unexpected and valid circumstances, the protocol registry will be immediately updated and, if required, the bioethical committee will be informed.

The independent DSMB will review data after recruitment of 25, 50, and 75% of participants to review the study progress (including rate of recruitment and completeness of data) and all reported adverse events. The number of recruited children will be monitored and kept up to date. In case of an insufficient recruitment rate, defined as associated with the risk of not finishing the study within the established time (which is 2 years), we will advertise our trial among other pediatric wards and primary care physicians, however, only if adequately trained personnel is present.

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