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. 2023 Aug 30;13(8):e068487. doi: 10.1136/bmjopen-2022-068487

Table 3.

(A) Sample size for the overall population (alpha=0.05). (B) Sample size for high-risk group (alpha=0.05). (C) Sample size by region (alpha=0.025)

Baseline risk Risk reduction Evaluable sample size per arm
Power=0.80 Power=0.85 Power=0.90
(A)
3% 20% 11 455 13 103 15 334
3% 25% 7133 8159 9548
3% 30% 4815 5508 6446
8% 20% 4096 4686 5483
8% 25% 2554 2921 3419
8% 30% 1727 1975 2311
14% 20% 2204 2521 2950
14% 25% 1377 1575 1842
14% 30% 932 1066 1247
(B)
6% 20% 5568 6369 7453
6% 25% 3470 3969 4644
6% 30% 2344 2681 3138
(C)
8% 20% 4961 5607 6477
8% 25% 3093 3496 4038
8% 30% 2091 2363 2729
14% 20% 2669 3017 3485
14% 25% 1677 1884 2176
14% 30% 1129 1276 1474