Table 2.
Baseline characteristics of those aged 65-80, by treatment: age, sex, race, height, weight, BMI and medication use.
| All | First randomization | Second randomization | |||||
|---|---|---|---|---|---|---|---|
| PRM | Placebo | PRM | Placebo | ||||
| N | 281 | 137 | 144 | 198 | 75 | ||
| Characteristic | Visit | ||||||
| Age (years) | 1 | Mean (SD) | 71.0 (4.1) | 71.1 (3.8) | 70.9 (4.4) | 70.9 (3.9) | 70.9 (4.4) |
| Sex | N (%) female | 182 (64.8%) | 89 (65.0%) | 93 (64.6%) | 128 (64.6%) | 50 (66.7%) | |
| Race* | N (%) white | 280 (100.0%) | 137 (100.0%) | 143 (100.0%) | 198 (100.0%) | 74 (100.0%) | |
| Height (m) | 1 | Mean (SD) | 1.65 (0.09) | 1.65 (0.09) | 1.64 (0.09) | 1.65 (0.09) | 1.64 (0.09) |
| Weight (kg) | 1 | Mean (SD) | 73.3 (13.0) | 73.1 (14.1) | 73.6 (11.8) | 73.2 (13.2) | 74.1 (12.6) |
| BMI (kg/m2) | 1 | Mean (SD) | 27.0 (3.8) | 26.8 (3.6) | 27.3 (3.9) | 26.8 (3.6) | 27.7 (4.2) |
| Taking any medications |
1 | N (%) | 265 (94.3%) | 130 (94.9%) | 135 (93.8%) | 187 (94.4%) | 70 (93.3%) |
| Taking codeine† | 1 | N (%) | 73 (26.2%) | 35 (25.7%) | 38 (26.6%) | 50 (25.5%) | 20 (26.7%) |
| Taking codeine | 2 | N (%) | 58 (20.6%) | 28 (20.4%) | 30 (20.8%) | 40 (20.2%) | 16 (21.3%) |
| Confirmed codeine analgesic |
2 | N (%) | 43 (15.3%) | 18 (13.1%) | 25 (17.4%) | 25 (12.6%) | 16 (21.3%) |
*One patient missed observation
†Two patients missed observations at Visit 1
PRM, prolonged release melatonin; SD, standard deviation