Table 2.
Analysis of primary outcome (shell).
| Time point | Intervention, number, mean (SD) | Control, number, mean (SD) | Mean difference (95% CI) | p Value |
|---|---|---|---|---|
| Pain intensity at | n = xx | n = xx | ||
| 18 wksa | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 26 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| 52 wks | xx (xx) | xx (xx) | xx (xx to xx) | .xx |
| Overall intervention effectb | .xx |
a, b: p values are from a mixed effects model comparing between group differences at 18-weeks post-randomization (a: primary outcome) and over the entire 52-week trial (b).