Sample size {14}
stroke, Stroke
STROKE, STROKE
The study is predicted to have 90% power in the analysis of both primary outcomes at a significance level of 2.5% for each individual test to account for planned correction for multiple comparisons with a target familywise error rate of 5%.Sample size calculations were performed assuming a mean difference of 4 points in the SIS-p score between the groups at the 12-month follow-up. There is uncertainty regarding the minimum clinically important difference in the SIS-p, but differences in sizes between 10 and 15 points have previously been suggested [The sample size calculation for the mRS score was based on aggregated unpublished data from the Swedish Stroke Register (Riksstroke). The marginal distribution of mRS scores collected 12 months after stroke among Swedish patients was Thus, 940 patients should be sufficient for both primary outcomes. To account for a 15% loss to follow-up rate, we plan to recruit 1106 patients for the study (Fig. 