2.3. Ethics
The study was registered in the Brazilian Research Registry under No. 43408615.7.0000.5327, in the Brazilian Registry of Clinical Trials (ReBEC) under No. RBR-2h2hjy and approved (150066) by the Research Ethics Committee of Hospital de Clínicas de Porto Alegre (HCPA). Patients and their legal guardians provided written informed consent after reading and understanding the intervention program and their rights.