Statistical analysis
The primary objective was to determine the placebo-adjusted median percentage difference in fasting TG levels between weeks 0 and 12 of treatment. According to data from the MARINE trial, the difference in effectiveness between IPE 4 g/day and placebo was estimated to be 30% (51% standard deviation). With 100 patients in each group, IPE 4 g/day, and placebo, there would be 98.5% statistical test power at a two-sided significance level of 0.05 (based on the PASS 12.0 software). It was anticipated that there was a difference of 25.4% (with a standard deviation of 51%) between IPE 2 g/day and placebo (data from the MARINE study). If 100 patients were assigned to the IPE 2 g/day group, and 100 patients to the placebo group, the statistical test would have a power of 94% at a significance level of 0.05 for two-sided analysis (based on PASS 12.0 software). A total of 360 patients were intended for randomization, with 120 in each group, taking into account a 20% dropout rate from randomization until study completion.The statistical evaluation was produced with SAS 9.4. For the main effectiveness analysis, the modified intent-to-treat (mITT) data set, per protocol set (PPS) data, and Safety Set (SS) data were used. A covariance model (ANCOVA) was used for the effectiveness analysis, with the treatment group, gender, and baseline statin usage as variables and baseline TG value as a covariate. If a normal distribution or homogeneity of variances could not be met, nonparametric intergroup comparisons were made using Wilcoxon rank-sum tests with the interquartile and median ranges for each group. Additionally, Hodges-Lehmann two-sided 95% and 99% CIs for the predicted median and treatment differences for each comparison across groups were supplied. In all two-sided statistical tests, the threshold for statistical significance was established at 