Secondary outcome analysis
The one-sample Kolmogorov–Smirnov test was used to assess the normality of the quantitative data. Normally distributed output data are presented as the mean (standard deviation, SD) and were compared using Student's VAS, RSS, IUC and FHR were assessed longitudinally between groups with a linear mixed model using the restricted maximum likelihood method and accounting for patient-level clustering (random intercept) under an unstructured model. The baseline values of VAS, RSS, IUC and FHR (T0) were included as covariates to ensure statistical balance and reduce error variance [