Statistical analysis
REGRESSION
Data were analyzed by intention and per-protocol according to the data subset in which they were located. Continuous quantitative data were presented as median (IQR) or mean (SD). Qualitative data were expressed using percentage and number. T-test, Mann-Whitney U test, exact Fisher tests or χ 2 test were used for comparison between groups, according to the type and characteristics of the variables. The receiver operating characteristic (ROC) curve was conducted to confirm the cut-off value of continuous variable. To analyze the factors predicting "First past success without pvwp," a binary logistic regression using the enter method was employed. Before including the independent variables, a multicollinearity test was performed to ensure that the variables being included in the model had a variance inflation factor (VIF) of less than 3. We assessed non-inferiority for the primary endpoint using bilateral 95% CI [