*Statistically significant between-group difference in mean change (p < 0.05).
a within treatment p values are from t-tests on LS Mean change; p values and LS Mean for change from baseline are from analysis of covariance model: change = treatment + baseline + geographic region (Type III sums of squares).
b within treatment p values are from t-tests on LS Mean change; p values are from Type III sums of squares and Kenward-Roger approximation as denominator degrees of freedom; MMRM analysis: change = treatment + baseline + geographic region + visit + treatment * visit.
For CELP, there were significant positive changes in MMSE (mean change 2.67, P = 0.04), DRS (mean change 4.67, P = 0.03), and BAPM (mean change −0.26, P = 0.03), respectively, as well as a marginal significant change in HKLLT (mean change 4.17, P = 0.06).
No significant differences were found in the TELP and control groups, except in MBI (mean change 2.5, P = 0.04) and GDS (mean change 2, P = 0.03), and a marginally significant change in MMSE (mean change 1.33, P = 0.09) in TELP.
Days per month with headache at the baseline and at the end of intervention period were 6.40 and 4.58 (mean change −1.81, p < 0.0001), respectively; days with neck and shoulder pain were 7.48 and 6.18 (mean change −1.30, p = 0.0179); days of analgesic consumption were 1.67 and 1.17 (mean change −0.50, p = 0.0222).
Unpaired t-tests with adjustments for multiple comparisons were used to evaluate group mean change differences (P ⩽ 0.05/25 ⩽ 0.002).
Similarly, readiness as assessed by the RTCQ also increased (mean change +0.14, p < 0.0001).
However, the change in EQ-5D score between these follow-ups was not significant (mean change 0.03, p = 0.2).
In those achieving the iPTH target, mean relative vitamin D dose decreased, from 1.6 to 1.4, although this change was not statistically significant (mean change −0.1; p = 0.18).
The changes in EQ-5D score between the 2- and 7-year follow-ups were not statistically significant (mean change 0.03, p = 0.2).
