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The trial sample size was determined to detect a difference in the primary outcome, total minutes of weekly exercise at 12 months.
Study group sizes were determined to detect a difference of 1.8 kg between test and control groups; with a power of 80% and a standard deviation (SD) of 2.0 and a type I error of 5%, a sample size of 21 subjects in each group was required, with a total of 42 subjects (Sample power, SPSS, Chicago, Illinois, USA).
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The sample size has been determined to detect a significant difference in the SGRQ at 1 year.
The sample size was determined to detect a clinically important difference (at least 15%) in response rate between the two study arms.
As the sample size for this study was not determined to detect differences between washout and direct-switch patients, the power for testing differences between these groups is unknown.
The sample size was determined to detect differences in biological markers of pre-eclampsia.
A power analysis of the metastasis data was performed to determine its ability to detect a difference.
A total of 2575 patients was determined to provide 80% power to detect a difference in prevalence of 20 25% between treatment groups at a 5% significance level.
Sample size was determined to achieve 80% power to detect a difference inferior to 2.5 points in HAM-A total score on day 28 between the two groups.
With a two-sided test at level 0.05 and 176 patients per treatment group, the study was determined to have 80% power to detect a difference between the treatment groups of at least 0.06 L in the change from baseline FEV1 value.
Using this sample size, it was determined that it would be possible to detect a difference of 3.5% between two countries for a binary outcome (based on 90% compared with 93.5% for potential high adherence to recommendations, as anticipated for some process measures) with 80% power by a standard χ test (α = 5%).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com