2.1. Study design
RECRUITMENT
This randomized, controlled, blinded clinical trial was written according to the Standard Protocol Items: Recommendations for Interventional Trials checklist and following the Declaration of Helsinki. This protocol was approved by the Research Ethics Committee of the Nove de Julho University on October 27, 2020 (acceptance number: 4.365.565). This trial has been registered in ClinicalTrials.gov (ID: NCT04911140). This study is recruiting.After a verbal and written explanation of the study, the participants who agree to take part in the research will sign the informed consent form. All participants will be seen at the clinic of specialties at Nove de Julho University - São Paulo, Brazil.The patients and/or the public were not involved in the design, recruitment, and conduct of the study. Standard Protocol Items: Recommendations for Interventional Trials schedule of enrollment, interventions, and assessments according to Figure SPIRIT schedule of enrollment, interventions, and assessments. Pg 5. SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials.