Statistical analysis
REGRESSION, SECONDARY
A total of 342 patients (1:1 randomization) were planned for evaluation as the intention-to-treat (ITT) population. Assuming a 10% drop-out rate, the final sample size was calculated to be 380 patients (190 per group). With these patient numbers and under the assumption that technical success rate would be 90% in control group and 75% experimental group, the study had approximately 80% power to show non-inferiority of the experimental group compared to the control group at a one-sided significance level of 0.025, with a lower confidence bound for the difference in technical success rate greater than − 15%. The non-inferiority margin was based on results of a pooled analysis and after discussion with contributing physicians who stated that this noninferiority margin of 15% would be clinically relevantPrimary and secondary endpoints were assessed in the ITT population, which included patients who were randomized. Per-protocol analysis was additionally performed for patients who had no additional rescue techniques in DBC. Values are presented as mean ± standard deviation (SD), median (interquartile range [IQR]), range for continuous variables, or as the number (%) of subjects for categorical variables. For primary endpoint, the primary hypothesis of non-inferiority of the experimental group relative to control group was tested first. If non-inferiority was established, a superiority test was done without multiplicity adjustments. Secondary and safety endpoint analyses were conducted using Pearson Chi-square test, Fisher's exact test, or Wilcoxon rank sum test as appropriate as indicated. To determine meaningful variables for DBC, odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated using multivariable logistic regression analysis. All reported 