Statistical analysis
bleeding
BLEEDING
The sample size for the study was calculated based on a level 0.025 test to exclude a probability of hemostasis within 5 min that was 10% less among subjects treated with CHM compared to those treated with GHM. The 10% non-inferiority margin is based on an FDA guidance for industry on non-inferiority clinical trials [Patients were randomized 1:1 using computer-generated permuted block randomization. Lists with a block size of 4 were generated at the initiation of the study using the RandList software (Datlnf GmbH, Tübingen, Germany). The results for the effective achievement of the primary end point were statistically assessed using an intention-to-treat analysis. The time to cessation of bleeding was compared using the Gehan-Wilcoxon test. The between-group difference of hemostatic rate and corresponding 95% confidence intervals (CIs) for this difference were calculated. CHM was considered non-inferior to GHM if one-sided P value was < 0.025. because the non-inferiority test is one-sided by nature, a clinical significance level of 0.025 was used for the non-inferiority test to keep the duality between the test and 95% CI as well as the same level of rigor of the two-sided test. The baseline and short-term clinical follow-up data were compared between the groups using the Fisher’s exact test. The number of distal anastomoses was analyzed by nonparametric analysis of variance (Kruskal–Wallis ANOVA). The IBM SPSS Statistics package (version 23.0, IBM-SPSS Inc., Armonk, NY) and SAS System software (version 9.3, SAS Institute, Cary, NC) were used for all statistical analyses.