Table 2.
Background of Safety Population per Cohort
| Cohort 1 | Cohort 2 | Cohort 3 | Pooled | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Measure | BIW | QW | P | BIW | P | BIW | P | P | |
| Age | n | 20 | 20 | 10 | 20 | 5 | 20 | 5 | 20 |
| (y) | Mean | 61.3 | 58.9 | 58.3 | 56.4 | 57.8 | 58.7 | 63.8 | 59.6 |
| SD | 5.8 | 5.5 | 5.1 | 4.3 | 8.2 | 5.5 | 6.3 | 6.4 | |
| Height | n | 20 | 20 | 10 | 20 | 5 | 20 | 5 | 20 |
| (cm) | Mean | 154.7 | 154.9 | 157.3 | 156.1 | 153.6 | 155.4 | 154.7 | 155.7 |
| SD | 5.1 | 5.6 | 3.5 | 5.8 | 6.4 | 5.7 | 3.8 | 4.5 | |
| Body weight | n | 20 | 20 | 10 | 20 | 5 | 20 | 5 | 20 |
| (kg) | Mean | 55.1 | 52.9 | 58.9 | 51.6 | 51.2 | 55.2 | 51.6 | 55.2 |
| SD | 6.5 | 6.4 | 4.9 | 7.6 | 5.2 | 7.7 | 7.0 | 6.5 | |
| BMI | n | 20 | 20 | 10 | 20 | 5 | 20 | 5 | 20 |
| (kg/m2) | Mean | 23.0 | 22.0 | 23.8 | 21.2 | 21.7 | 22.9 | 21.6 | 22.7 |
| SD | 2.5 | 2.4 | 2.4 | 2.5 | 1.4 | 3.1 | 3.1 | 2.5 | |
| 25‐Hydroxyvitamin D3 | n | 20 | 20 | 10 | 20 | 5 | 20 | 5 | 20 |
| (ng/mL) | Mean | 16.4 | 18.6 | 17.5 | 23.5 | 23.9 | 21.0 | 19.2 | 19.5 |
| SD | 3.8 | 4.3 | 4.7 | 4.0 | 6.0 | 5.2 | 3.6 | 5.3 | |
| Serum albumin‐corrected calcium | n | 20 | 20 | 10 | 20 | 5 | 20 | 5 | 20 |
| (mg/dL) | Mean | 9.01 | 9.06 | 8.99 | 9.17 | 9.32 | 8.95 | 8.82 | 9.03 |
| SD | 0.17 | 0.22 | 0.20 | 0.20 | 0.45 | 0.25 | 0.25 | 0.33 | |
BIW, twice‐weekly 28.2‐μg injection group; BMI, body mass index; P, placebo group; pooled P, pooled placebo group; QW, once‐weekly 56.5‐μg injection group.