Ethics approval and protocol registration
This clinical trial investigation was approved by the local Research Ethics Committee (protocol # 2.647.386) of CEUMA University (São Luís, MA, Brazil), and written informed consent was obtained from all participants. Participants were informed of the nature and objectives of the present study. The study was registered in the Clinical Trials Registry (RBR-3sqsh8; first trial registration: 09/07/2018). The protocol established by the Consolidated Standards of Reporting Trials (CONSORT) [