Table 2.
Hypothesis to be evaluated: μ
r − μ
b ≤ d days vs H1: μ
r − μ
b > d days Assumptions: CI, 97.5%; expected difference in means 0.25 days; randomization 1:1 | ||||||||
---|---|---|---|---|---|---|---|---|
Power | 80% | 90% | ||||||
Non-inferiority limit | − 1 day | − 0.5 days | − 1 day | − 0.5 days | ||||
Standard deviation | 1.5 | 2 | 1.5 | 2 | 1.5 | 2 | 1.5 | 2 |
N per group | 24 | 42 | 64 | 113 | 32 | 55 | 86 | 151 |