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Comparing study arm to the waitlist control arm, mean scores reflecting self-concept were not significantly different (p = 0.5027) at baseline.
The difference in health status between participants with definite HF in the two study arms at 12 months will be compared with ANCOVA.
Those with missing outcome data were compared by study arm to assess assumptions of missing at random.
When comparing the three study arms with the standard office hour appointment arm, attendance at initial appointment was significantly lower for evening appointments (OR=0.756, P<0.001) and slightly lower for Saturday appointments.
Levels of biomarkers at all time points and changes from baseline were compared across study arms using Wilcoxon rank sum test.
GLM (general linear model) (family = Gaussian, link = identity) was used to compare the two study arms for the primary and secondary end point at 3 months after the surgery.
The level of missing data will be compared by study arm.
Median levels of biomarkers at baseline and at weeks 4, 12, and 48, as well as relative changes from baseline to weeks 4, 12, and 48 were compared across the 2 study arms by Wilcoxon rank sum test.
Also, average hospital stay will be compared between both study arms.
Based on 12-month plain radiographs, as compared to baseline radiographs, we will compare the proportion of subjects in the two study arms suffering at least one new-onset fracture using the binomial test.
Variation in blood loss was only slightly larger in study arms with ≤200 women compared with larger study arms.
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