2.16. Ethical considerations
VIRUS
The study was approved at December 2018 by the Research Ethics Committee of the Universidade do Estado da Bahia (No. 3.068.511/2018). The written ICF was presented and signed by all participants. All study procedures followed Brazilian ethical legislation and the trial has been sent to registry at The Brazilian Clinical Trials Registry (REBEC) since February 2019. All adjustments and information required by REBEC had no ethical or methodological implications and were made accordingly. The approval was updated online as January 2020 (No. RBR-79dn4k).The COVID-19 pandemic was declared in March 11Expansion of the data collection window on Visit 2 to 1 month before and 1 month after the 180 days counted from the date of Visit 1;Optional conduction of final interview (Visit 2) via phone call, registered on a file containing telephone number, date and time of interview. This modification was important to preserve isolation during peak phases of the virus dissemination, while maintaining the study’s feasibility.