Ethics approval and consent to participate
The study procedures were approved by the research ethics board from the Hospital de Clínicas de Porto Alegre on 8 August, 2017 (protocol no. 20170291). The informed consent document includes the objectives of the study, a description of the testing procedures, explanation about interventions and its randomized allocation nature, the potential risks and benefits involved in the study, information on anonymized data sharing, and liabilities of the researcher staff. Once a subject decided to participate, a signed and personally dated informed consent was obtained from the subject before any trial-related procedure. A copy of the consent form was given to the participant.