For the brief protocol concept proposals, is it necessary to have a complete description of the statistical considerations and sample size power calculations?
No. A simple sentence that reflects the key considerations for determining your sample size will be sufficient., For example: The sample size was computed using SAS/STAT software to detect a mean difference of 25 L/min in AM PEF between treatment A and treatment B with a two-sided, 0.05 significance level test with 90% statistical power and accounting for a 15% drop-out rate.
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