2.5. Statistical analysis
This trial was designed to show the superiority of A5E over E and A5 in percentage reduction of LDL cholesterol levels. A10 as the reference standard of moderate-intensity statin was used to assess the utility of A5E in lowering LDL cholesterol. The full analysis set was used for the efficacy assessment and the safety analysis set for the safety assessment. The full analysis set included patients who had a primary end point assessment at least once after administration of an investigational drug, and the safety analysis set included all those who administered an investigational drug. Efficacy and safety analyses were performed for the intention-to-treat population. Efficacy was established by co-primary endpoints by using a gatekeeping method. If the superiority of A5 over E in the reduction of LDL cholesterol levels is demonstrated, then the superiority of the A5E combination treatment over E and A5 was assessed.The sample size was calculated to be 240 patients (60 patients per group) to obtain an overall 80% power of test combined with a 20% drop-out assuming a weighted mean difference of −10.43% in LDL cholesterol level in the A5 and E groups with a standard deviation of 14.3% from the conservative perspective.