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To detect a minimal clinically important change of 0.26 points [ 39] in mean HAQ scores between both groups, assuming a SD of: 0.66 (SE*√N = 0.04*√271 = 0.66) [ 40] with 80% power and a two-sided 5% level, we will need 102 patients per arm (effect size is 0.26/0.66 = 0.39).
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For statistical analysis between two groups, assuming equal variance, one-tailed Student's t test was performed (p < 0.1).
A multiple linear model was used to test for difference between genotype groups assuming an additive model in quantitative trait studies.
A group size of 30 participants (in the non-CPG and CPG groups combined) gave a power of 0.8 for detecting a 2.4 fold difference in antibody responses between the groups, assuming a coefficient of variation in antibody responses of 1.7 and a significance level of 0.05.
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.
To detect a 10% difference in LVEF between two groups (assuming a SD of 15%), one needs at least 70 patients (35 in each group) to achieve 80% power.
Induction of total structural aberration between two groups (assuming 33 × number of metaphase spreads scored for the purpose of determining proportion values) was compared using Z-test to find the statistical significance between TAP control and TAP-Lxn cells.
It also had a similarly low power of 80% to detect a 50% reduction in early neonatal mortality between treatment groups, assuming a two tailed test, with α=0.05 and an early neonatal mortality rate of 15 per 1000 live births.
The targeted sample size was 150 patients (100 receiving IFX+NPX and 50 receiving PBO+NPX) for 90% power to detect a 30% difference in ASAS partial remission between treatment groups, assuming a 15% withdrawal rate.
We calculated that 80 patients would be needed to detect an absolute difference of 30% in anti-factor Xa levels 4 hours after enoxaparin administration between the groups, assuming a power of 80% and a significance level of 5%.
We estimated that 35 patients in each group would be required to achieve 80% power; α=0.05 to detect a mean difference of four hours in the recovery time between the groups, assuming a mean recovery time of 10 hours (SD 2.5 hours) in the antivenom plus prazosin group and 14 (SD 3) hours for the prazosin alone group.
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