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A revised sample size of 66 per treatment arm (allowing 10% loss to follow-up) gave a power of 90% at the 95% confidence level to detect this difference.
A revised sample size was calculated to detect a difference from 1% (the best likely failure rate in any arm) and 15% (above which no drug could be deployed).
The trial steering committee supported a revised sample size calculation based on a follow-up rate of 85% and no effective clustering.
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When re-estimating the sample size using data from an internal pilot study the revised sample size estimate either stays the same or increases, it cannot be less than the original estimate [ 24, 25].
The trial will not proceed if the revised sample size calculation suggests a total sample size notably greater than 600 will be required.
The trial will not proceed if the revised sample size calculation suggests a total sample size greater than 600 will be required.
In fact, the mean in Remington et al [ 20] was 66%, so the revised sample size calculations on the continuous measure are powered for a more modest increase from 65%to8585% (an absolute difference of 20%).
Data regarding secondary endpoints must, however, be interpreted within the limits of the revised sample size.
Revised sample size calculations suggested that, on the basis of these more recent opinions, between 800 and 1200 patients would have been required.
These findings call for revised sampling design in a coordinated, region-wide framework.
This resulted in a revised final sample size (see the "Sample size and statistical analysis" section below).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com