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A sample size of 120 patients was planned to have a power of 80% to detect a difference in the time spent in hypoglycemia between study groups, assuming a population difference of 42%, a SD of 1.12, an α-level of 0.05, and a loss to follow-up of no more than 17%.
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Common slope: the estimated common slope across study groups assuming no interaction.
A multiple linear model was used to test for difference between genotype groups assuming an additive model in quantitative trait studies.
A sample size of 91 patients was based on similar studies conducted with other RA treatments 6 17 and 0% difference between treatment groups assuming an 80% response rate.
The study had 80% power to detect a difference in mean glucose of 30 mg/dl between groups, assuming SD of 60 mg/dl.
The study was designed to detect a 25% difference in the proportion of participants choosing comfort care between the two groups, assuming the rate in the verbal group was 60%.
With 754 patients in two groups, the study has more than 80% power to detect a difference of 1 point in SCORE function at 12 months between the two treatment groups, assuming a SD of 4.5 points.
The study had 80% power to detect a 14.4% difference between the intervention and control groups, assuming that the null rate for asking about CAM use was 10%.
The sample size was calculated based on a 10 point difference (10%) in the DASH between the two groups studied, assuming a 95% confidence interval, 80% statistical power and 20% sampling error, resulting in 36 patients in each group.
Based on two earlier studies, a difference between both study groups of 2% in SCORE risk assessment was assumed [ 24, 25].
With 12 subjects in each treatment group, the study was designed to have approximately 74% power to detect a 45% difference in hs-CRP between the treated group and the placebo group, assuming the treated group would have a 50% reduction in hs-CRP while the control group would have a 5%reductionn.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com