2.6. Statistics
pain
SECONDARY, ADVERSE EVENT, OXIDATIVE STRESS
The primary objective of this study was to quantify changes in the subjects’ self-reported pain and pain interference compared to the study baseline, and the secondary objective was to determine the tolerability of the intervention by assessing the adverse event rates and oxidative stress in the peripheral blood mononuclear cells (PBMC). The statistical analyses used the following parameters based on the pilot study data (data on file): the mean of the primary outcome minimum detectable effect size; the standard deviation of the population outcome for the primary outcome; and the levels of significance for the Type I and Type II error rates. They were performed using JMP 15 (SAS Institute, Cary, NC, USA). Power calculations were performed in order to determine that the data analyses would be based on a power of 0.85 so as to detect significant differences between and within the groups using dependent and independent analyses with a level set at 