Table 2.
Demographic characteristics of the ITT and PP subgroups.
| Characteristic | ITT population (n = 386) |
PP Population (n = 346) |
||
|---|---|---|---|---|
| Investigational drug (n = 191) | Control drug (n = 195) | Investigational drug (n = 171) | Control drug (n = 175) | |
| Gender, n (%) | ||||
| Women | 119 (62.30) | 117 (60.00) | 107 (62.57) | 108 (61.71) |
| Men | 72 (37.70) | 78 (40.00) | 64 (37.43) | 67 (38.29) |
| Age, years (mean ± SD) | 27.74 ± 12.51 | 31.04 ± 14.41 | 28.04 ± 12.81 | 31.15 ± 14.42 |
| Range | 12.19–70.38 | 12.01–67.54 | 12.19–70.38 | 12.00–67.54 |
| Median (IQR) | 25.12 (17.60–34.39) |
28.79 (18.68–41.35) |
25.39 (17.69–34.94) |
28.79 (19.01–41.40) |
| Ethnicity, n (%) | ||||
| White | 112 (58.64) | 120 (61.54) | 99 (57.89) | 109 (62.29) |
| Mixed | 32 (16.75) | 33 (16.92) | 28 (16.37) | 27 (15.43) |
| African-American | 42 (21.99) | 37 (18.97) | 39 (22.81) | 34 (19.43) |
| Asian | 5 (2.62) | 5 (2.56) | 5 (2.92) | 5 (2.86) |
| BMI, km/m2(mean ± SD) | 24.96 ± 5.39 | 25.02 ± 5.07 | 24.65 ± 5.36 | 25.03 ± 4.84 |
| Range | 15.27–44.31 | 15.27–45.92 | 15.27–44.31 | 15.27–39.81 |
| Median (IQR) | 24.13 (20.76–28.41) |
24.61 (21.90–27.29) |
23.72 (20.55–28.13) |
24.64 (21.95–27.36) |
| History of smoking; n (%) | ||||
| Non-smokers | 177 (92.67) | 181 (92.82) | 158 (92.40) | 162 (92.57) |
| Ex-smokersa | 14 (7.33) | 14 (7.18) | 13 (7.60) | 13 (7.43) |
SD, standard deviation; BMI, body mass index; NIS, nasal index score; IQR, interquartile range; ITT, intent to treat population; PP, per-protocol population.
a
Stopped smoking three months prior to study entry.