Statistical analysis
SECONDARY
Since pre-study calculation of sample size was not performed, a Baseline data are reported as proportions for categorical variables; as mean ± standard deviation (SD) for normally distributed data; or as median with interquartile (IQR) for nonnormally distributed continuous variables. The primary and secondary outcomes were compared between the two treatment groups using Chi-square or Fisher’s exact test, or by Wilcoxon rank-sum test, as appropriate, at a two-sided significance level of 0.05. Kaplan–Meier estimates for the distribution of time to culture conversion by treatment group were constructed, censoring data on patients who had no follow-up sputum samples, did not achieve culture conversion by the end of the treatment, permanently changed assigned regimen, were lost to follow-up or died before culture conversion occurred. Considering the nature of this pilot clinical trial, small sample size and the lack of pre-analysis plan, all results should be explained as exploratory. Analyses were performed with IBM SPSS 26.0 (IBM Corp., Armonk, NY) and R software, version 4.1.1 (R Foundation for Statistical Computing).