Sample size and statistical analysis
EVENTS, SECONDARY
Data are presented as means and standard deviations (SDs) for continuous variables, and as frequencies and percentages for categorical variables. Because of the lack of evidence for EMS-dependent AEs, our sample size calculation was based on analysis of our own data with an assumed AE rate of 2% for the conventional physician-based EMS. We assumed a non-inferiority margin of 1.5% and a power of 80%, and we allocated an overall significance level of 5% to The final analysis of all randomised cases was performed at a significance level of 2.25%. Considering an assumed dropout rate of 10% evenly distributed over the stages and groups, the calculated sample size using Addplan 6.0 [To evaluate all dichotomous secondary endpoints, we used two-sided chi-square tests (proc FREQ). The exact Fisher test was applied for values < 5, and no further evaluation was performed in the case of 0 events in both groups. All continuous endpoints were evaluated with two-sided t-tests (proc TTEST), and the bootstrap statement with 10 000 bootstrap samples was used to calculate the bootstrap t intervals for skewed data.Except for the primary endpoint, 