Statistical methods
STD
The PCS and MCS data are presented as the mean score ± standard deviation (std dev). The Shapiro-Wilk test was used to assess normality. The data were normally distributed. Therefore, a paired t-test was employed in the statistical analysis of intragroup changes from baseline at 8 weeks and 16 weeks. The p-values presented are for a two-tailed test. Student’s t-test was used to analyze intergroup changes, e.g., mean values of demographic characteristics for the prednisone and placebo arms of the study. SigmaStat v4.0 statistical software was used for the statistical analyses.