Table 2 Comparison of sample sizes required for hypothetical trials with mean IMT or TPV as primary endpoints
Endpoint | Significance Level | Power | Ndiabetic | Nnon-diabetic | N total |
|---|---|---|---|---|---|
IMT (inverse): 6 μ m difference | |||||
0.05 | 0.70 | 601 | 601 | 1202 | |
0.05 | 0.80 | 764 | 764 | 1528 | |
0.05 | 0.90 | 1022 | 1022 | 2044 | |
TPV (square root): 45.9 mm3 difference | |||||
0.05 | 0.70 | 68 | 68 | 136 | |
0.05 | 0.80 | 86 | 86 | 172 | |
0.05 | 0.90 | 115 | 115 | 230 | |