*2.10. Ethics*

This study was approved by the Research Ethics Committee of the Faculty of Health Sciences of Trairi (FACISA), of the Federal University of Rio Grande do Norte (UFRN), under opinion 3.980.703/2020 and CAAE 29582020.8.0000.5568. Written informed consent will be obtained from parent or guardian prior to data collection. The trial was prospectively registered at the Brazilian Registry of Clinical Trials (ReBEC) (RBR-2Y2Z8P). The study follows the Consolidated Standards of Reporting Trials (CONSORT) to pilot or feasibility trial.
