Ethical aspects
RESOLUTION
The study followed the recommendations set forth in Resolution No. 466, dated December 12 The study was approved by the Committee of Ethics in Research with Human Beings of a public university under opinion No. 1,322,956 and Certificate of Presentation of Ethical Appreciation No. 49827815.2.0000.5390; approval was also obtained in the Brazilian Registry of Clinical Trials under No. U1111-1210 -2389, which can be accessed at The manuscript was prepared based on the rules set forth in the Consolidated Standards of Reporting Trials (CONSORT).