2.2. Study Design
This crossover, prospective, double-blind, randomized, placebo-controlled study was approved by the ethics committee of the Federal University of Minas Gerais (CAAE: 31990720.7.000.5149) and registered in the Brazilian registry of clinical trials under code RBr-6wg54rb. The participants involved in this study signed an informed consent form that was prepared in accordance with the Declaration of Helsinki. The protocol for this study has been accepted for publication by the JMIR research protocols. The abstract and the preprint are already available on PubMed [