Ethics committee approval
This work was approved by the HC-FMUSP Research Ethics Committee under the CAAE number 39984320.5.0000.0068. This research project was carried out following the relevant guidelines and regulations and was approved by the Ethics Committee for the Analysis of Research Projects (CAPPesq). This study received approval from the Brazilian National System of Genetic Registration (SisGen), under the number AC29D69, and registered as a clinical trial under identification number NCT04810572 (ClinicalTrials.gov).