Ethics approval and consent to participate
The SI! Program trial was conducted in accordance to the Declaration of Helsinki. The study was approved by the Committee for Ethical Research (CEI) of the Instituto de Salud Carlos III in Madrid (CEI PI 35_2016) and by the CEI of the Fundació Unió Catalana d'Hospitals in Barcelona (CEI 16/41) and the University of Barcelona Bioethics Committee (IRB00003099). Informed consent was obtained from the legally acceptable representatives (LAR)/parents of all participants in the study.