2.6. Statistical analysis
SECONDARY
Based on previous studies of IR pregabalin compared with placebo in patients with DPN,Full Analysis Set will be used as the main analysis group to evaluate efficacy while Per-Protocol Set will be used as a subanalysis set; Safety Set will be analyzed for safety data.Differences in VAS scores in each group after 8 weeks of treatment compared with baseline will be described statistically (number of subjects, mean, standard deviation, median, minimum, and maximum) and analyzed by analysis of covariance corrected for baseline as a covariate. SR pregabalin will be considered non-inferior to IR pregabalin if the lower bound of the 95% confidence interval for the least squares mean difference between the treatment groups is greater than the prespecified non-inferiority margin of 9.2 mm. The secondary endpoints will be analyzed using either analysis of covariance or Pearson’s chi-square test, depending on the characteristics of the variables. In addition, demographics, baseline characteristics, treatment compliance, and safety endpoints will be summarized using descriptive statistics. Treatment adherence will be calculated by dividing the number of tablets taken by the number of tablets scheduled for administration and then multiplying by 100. The data will be analyzed using IBM SPSS Statistics for Windows, Version 20 (IBM, Armonk, NY).