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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.
To detect a 0.7 kg difference in LBM between the groups, assuming a standard deviation (SD) of 1.0 kg, 34 patients are needed in each group with a significance level (two-sided) of 5% and a power of 80%.
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.
Although the sample size was dictated by the class size, a power calculation indicated that this sample size was sufficient to detect a difference of 5percentt in overall examination score between the groups (assuming power of 0.8 and significance level of 0.05).
On the basis of previous research, a target cell size of twenty-two was calculated to achieve a 90%% chance of detecting a difference in change in the body weight of 1·5%% of baseline body weight between the groups (assuming sd= 1·5).
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The sample size was calculated for each group to be 143; keeping beta error at 0.2, significance level 0.05 and with the percentage difference in poor glycemic control between the groups assumed to be 17% as determined in a systematic review by Lustman and colleagues [ 21].
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%.
The sample size determination in study 1 indicated that a total enrollment of 126 subjects would provide 90%% statistical power for detecting a 30%% difference in the response rate between the treatment groups, assuming a 30%% response in the vehicle control group and a two-sided type 1 error of 0.05.
Sample size and recruitment: A sample size of 64 in each group will have 80% power to detect a meaningful difference in health and quality of life state values or utilities of 0.05 between the two groups; assuming that the common SD is 0.100 using a two group t test with a 0.050 two-sided significance level.
A two-group continuity corrected chi-squared test with a two-sided 5% significance level had 80% power to detect a clinically relevant difference between the treatment groups, assuming 28% in the rofecoxib group and 14% in the lumiracoxib group when the sample size is 146 patients per treatment arm.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com