2.7. Statistical Analysis
ADVERSE EVENTS, LEAKAGE
The study population was divided into a safety assessment group, referring to the patients undergoing safety-related follow-up, and a full assessment group, representing the patients with whom the drug efficacy was tested. Statistical analysis of the primary endpoint of this study was performed as a two-tailed test with a significance level (α) of 0.1; all other analyses were based on two-tailed tests with an α of 0.05.Data were analyzed based on the number of participants, incidence rates, and number of adverse events related to the investigational drug, as well as their severity, measures taken, and outcomes. The number of participants by system organ class (SOC) and preferred term (PT), incidence rates, and number of occurrences were summarized. Descriptive statistics of the vital signs and quantitative laboratory tests represented the degree of change before and after the investigational drug administration. Changes within the administration groups were tested for differences compared with baseline using the paired To further analyze EG-Mirotin’s effects, the V1 cutoff indicating a significant decrease in ischemic index was determined using the ‘maxstat’ R package, and two groups were defined based on this cutoff. The repeated measures ANOVA test was used to identify changes in ischemic and leakage indexes over time. To assess the difference in average ischemic index between these two groups, the Wilcoxon test, repeated measures ANOVA, and Bonferroni post hoc analysis were used. R version 4.0.4 (R Project for Statistical Computing, Vienna, Austria), SPSS version 28 (IBM, New York, NY, USA), and SAS version 9.4 (SAS Institute, North Carolina, USA) were used for statistical analyses and graphical representation.