Safety/harms
All AEs, distinct by severity and relationship with the randomized drug, will be documented and listed. The number and percentage of AEs will be reported, per treatment arm and overall, along with the number and percentage of participants who experienced at least one AE. Moreover, the number of concomitant medications and changes from baseline in vital signs, routine biochemistry and hematology analyses, and in respiratory endpoints will be analyzed. Discrete safety endpoints will be compared using a chi-squared test. The denominator will be the safety population. Continuous safety endpoints will be compared using a Furthermore, AEs will be described according to the different pandemic periods [