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We calculated that at least 38 patients would need to be enrolled to detect a 4% increase in GLS after fluid expansion with a 90% statistical power and a two-sided alpha value of 0.05.
Overall, 852 participants are planned to be enrolled to detect a difference of one retrieved oocyte between the two treatment arms, with a common SD of 4.5.
Using simulations of size N=10,000, and defining statistical significance as α=5% (2-sided), 70 patients need to be enrolled to detect a mean treatment mean difference in the total CGI-P score of 2.0 with 80% power.
We estimated that a 500-mL difference in total fluid input would be relevant to the patients, and therefore 38 patients (19 in each group) would need to be enrolled to detect this difference with 80% power at a P value < 0.05.
(9) Briefly, 3000 patients were to be enrolled to detect an AE in one case out of 3000 patients with at least a power of 95%; however, during enrolment, target accrual was increased to 10 000 patients by the Japanese Health Authority to further evaluate the safety and efficacy of erlotinib.
A priori power analysis allowing an alpha error of 5% and statistical power of 80% revealed that 22 subjects needed to be enrolled to detect an average per subject bias of 5% with an SD of 8% from the reference measurement, a range detected by other commercially released cerebral oximeters and accepted by the Food and Drug Administration for regulatory findings.
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It shows how large a sample would have to be enrolled to be able to detect displacements of a specified value if the subpopulation had not been identified in advance.
We calculated that a sample of thirty patients would need to be enrolled to achieve 80% power to detect a log-linear trend in the primary endpoint assuming that the percentage increase of reactive hyperemia after exercise, as measured by TR, was 50 percentage points.
The studies using this clinical model are extremely costly due to the large numbers of patients that must be enrolled to have a reasonable probability of detecting a statistical difference between the treatment groups and the follow-up period is usually long.
In order to repeat the same results, we calculated that at least 70 patients in the resonant group should have been enrolled to guarantee a 90% power detecting a mean difference between IBP and NIBP of 15.61 mmHg with a significance level (alpha) of 0.05 (one-tailed).
Thirty-two patients were enrolled to the study.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com