Statistical analysis
dysuria
The analysis was carried out using the intention-to-treat (ITT) population, evaluating all participants who were included in the study after randomization, who received at least one dose of the medication, and who presented at V2.Demographic data were evaluated using descriptive analysis, presenting mean, median, standard deviation, minimum, and maximum if necessary.We calculated the percentage of participants presenting an excellent clinical response in 24 h for each group with the 95% confidence interval (CI), and the treatment with the test drug was considered superior to the comparator in symptomatic relief of dysuria if the lower limit of the 95% CI of the difference between groups was greater than the superiority margin.For categorical variables, a categorical change test, such as McNemar’s test, was applied to compare patients' notes (0 h, 12 h, 24 h, 48 h, and 72 h; comparison within each treatment). The Chi-squared test was used to test the significance of differences in proportions between drugs (test and comparator). The Kaplan–Meier method and the log-rank test assessed the time to relieve dysuria. Episodes of AEs were analyzed descriptively.