Ethical aspects
The project was submitted and approved by the Research Ethics Committees of the Faculty of Medicine of the University of São Paulo (FMUSP) with the Certificate of Presentation of Ethical Appreciation CAAE No. 22984819.8.0000.0065 and the Hospital de Clínicas de Porto Alegre (HCPA) CAAE No. 22984819.8.3001.5327. The clinical trial was also registered on ClinicalTrials.gov (