2.4. Statistical Analyses
The primary statistical analysis was centered on evaluating the efficacy of omega-3 fatty acids in reducing LDL-C levels compared to placebo. The analysis was conducted on an intention-to-treat basis, including all randomized patients who received at least one dose of the study medication and had at least one post-baseline efficacy evaluation. Percent changes in LDL-C levels from baseline to study end were calculated, and the comparison between the omega-3 fatty acid and placebo groups was performed using an independent Secondary analyses compared changes in high-sensitivity To address the possibility of genotype-related treatment effects, interaction terms between the treatment group and genotype were included in the models. Subgroup analyses were pre-specified for patients with and without PPARG polymorphisms based on the presence of the selected single nucleotide polymorphisms (SNPs).All tests were two-sided, with a significance level set at 0.05. Statistical power was maintained at 90%, accounting for a 5% dropout rate, resulting in a total sample size of 102 participants. Continuous variables were expressed as mean ± standard deviation (SD), and categorical variables were summarized with counts and percentages.For the analysis of SNP data, the Hardy–Weinberg equilibrium was tested using a chi-square test for each SNP among the placebo group.All statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC, USA), and figures were generated to visualize the distribution of changes and the treatment effects across subgroups.This analytical approach was designed to ensure robust detection of treatment effects and interactions, providing a comprehensive understanding of the impact of omega-3 fatty acids on lipid metabolism in the context of genetic variability.