Ethics approval and consent to participate
The study was approved by the Research Ethics Committee of the Hospital de Clínicas de Porto Alegre (2017–0523). This study was carried out in accordance with the Declaration of Helsinki and Brazilian regulatory guidelines and norms for research involving human beings (National Health Council Resolutions 466/12 and 441/11). At the first visit, inclusion and exclusion criteria were investigated as well as the informed consent was obtained from all participants of the study.