Statistical analysis
SE, incidense
SECONDARY
The analysis was by an intention-to-treat approach, including all participants who were randomised to a study arm. Categorical variables describing baseline data were presented in frequencies and percentages, and continuous variables with means and standard deviation (SD). Chi-square or Fisher’s exact test were used to evaluate differences in categorical variables between arm groups; for continuous variables, a Student’s t-test was used. For the primary efficacy endpoint an incidense density and ratio was calculated. Frequencies were reported for the primary safety endpoint and secondary outcome. Data analysis was performed in Stata SE 16.1 (StataCorp, USA).