Statistical analysis
SECONDARY
The collated data was entered into Excel 2013 and exported to SPSS 25 and R 4.1.2 for analysis. . Mann Whitney test was used to compare two independent groups. Categorical variables were reported using frequency tables and charts while continuous variables were reported using means and standard deviations. The study endpoints were analyzed for the per-protocol population. A sensitivity analysis was then conducted for the intention-to-treat population. For the primary endpoint analysis, a 95% confidence interval with a two-sided 5% level of significance approach was employed. A p-value ≤ 0.05 is statistically significant, however to reduce the chance of type I error in multiple testing, a p-value ≤ 0.003 is considered significant after correcting the alpha using the Bonferonni approach (A multiple tests of 5 variables with 3 levels (0.05/15 = 0.003)). The non-inferiority test was performed for only the primary end point, the secondary endpoints were analyzed for superiority. All missing values were excluded from the analysis.