Ethics statement
The study protocol was approved by the Research Ethics Committees of the State University of Londrina, Paraná, Brazil (CAAE 37277420.0.0000.5231), and the followed procedures were in accordance with the Helsinki Declaration of 1975, as revised in 1983.The study was registered in the Brazilian Registry of Clinical Trials (ReBEC) (RBR-8tygcz7) and complied with the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist.