Statistical analysis
ADVERSE REACTIONS, SIDE EFFECT
Statistical Analysis Both PP and ITT analyses were performed. Statistical analyses were performed using the computer program Statistical Package for the Social Sciences (SPSS), version 26.0 (IBM, Chicago, USA). The independent t-test was used for the comparison of 2 group means. The demographic data and frequencies of adverse reactions were compared using the chi-square test or Fisher’s exact test, when appropriate. The incidence of side effects was considered as a binomial variable (present-absent). Any “side effect” was considered absent if the subject reported the same complaint at baseline visit, as assessed by the questionnaire. Data were presented as the mean ± standard deviation or number and percentage. Differences were considered significant at p < 0.05. To detect differences in 