Statistical methods for primary and secondary outcomes {20a}
Primary outcome is a binary outcome presented as number of cases and percentage. Nominal data will also be presented as percentage. Continuous data will be presented as mean ± standard deviation or median ± interquartile range, based upon whether the assumption of normality holds (visual interpretation). Analysis of continuous data will be performed by applying the Students T-test for unpaired data in case of continuous variables with a normal distribution. Otherwise the distribution will be compared using the Mann–Whitney U-test. Chi2 test will be used for comparisons of categorical variables between the two groups. The Fisher’s exact test will be performed where applicable. Since data is clustered analysis will be performed using a generalized logistic mixed-effects model with cluster as random intercept. A P-value < 0.05 is considered statistically significant.