Table 4. Sample-size estimates based on delta NPD*.
Treatment Effect (mV) | Total Number of Subjects | |||||
90% Power | 80% Power | |||||
Average of Both Nostrils | Most-polarized nostril at Each Visit | Most-polarized nostril at Screening Carried Forward | Average of Both Nostrils | Most-polarized nostril at Each Visit | Most-polarized nostril at Screening Carried Forward | |
A. Comparison with placebo | ||||||
−5 | 288 | 206 | 226 | 216 | 154 | 170 |
−10 | 74 | 54 | 58 | 56 | 42 | 44 |
−15 | 34 | 26 | 28 | 26 | 20 | 22 |
−20 | 20 | 16 | 18 | 16 | 12 | 14 |
−25 | 14 | 12 | 12 | 12 | 10 | 10 |
B. Within-group comparison ** | ||||||
−5 | 73 | 53 | 58 | 56 | 40 | 44 |
−10 | 26 | 15 | 16 | 16 | 12 | 13 |
−15 | 11 | 8 | 9 | 9 | 7 | 7 |
−20 | 7 | 6 | 6 | 8 | 5 | 5 |
−25 | 6 | 5 | 5 | 5 | 4 | 4 |
Parts 1 and 2 combined analysis at Day 14.
Assume a single-arm study.