Ethics approval and consent to participate
The study was approved by the Ethical Committee, Universidade Metropolitana de Santos, Brazil, and all aspects of the Declaration of Helsinki were observed. It was registered at The Brazilian Registry of Clinical Trials (ReBEC) with the code RBR-6d8whb5 (UTN code: U1111-1277-6020) on 17/05/2022. The patients willingly volunteered for the trial, and provided written informed consent.