TABLE 1.
Summary of Demographics (All-Treated Analysis Set)
| RE104 5 mg (N=6) | RE104 11 mg (N=6) | RE104 20 mg (N=6) | RE104 30 mg (N=9) | RE104 35 mg (N=6) | RE104 40 mg (N=3) | Pooled RE104 (N=36) | Pooled Placebo (N=12) | All Participants (N=48) | |
|---|---|---|---|---|---|---|---|---|---|
| Age (y) | |||||||||
| n | 6 | 6 | 6 | 9 | 6 | 3 | 36 | 12 | 48 |
| Mean | 37.2 | 29.0 | 46.2 | 34.7 | 38.2 | 26.7 | 36.0 | 40.1 | 37.0 |
| SD | 8.47 | 10.53 | 10.07 | 8.96 | 13.26 | 1.15 | 10.92 | 13.01 | 11.47 |
| Sex | |||||||||
| Female | |||||||||
| n (%) | 0 | 2 (33.3) | 1 (16.7) | 3 (33.3) | 1 (16.7) | 2 (66.7) | 9 (25.0) | 4 (33.3) | 13 (27.1) |
| Male | |||||||||
| n (%) | 6 (100) | 4 (66.7) | 5 (83.3) | 6 (66.7) | 5 (83.3) | 1 (33.3) | 27 (75.0) | 8 (66.7) | 35 (72.9) |
| Ethnicity | |||||||||
| Hispanic or Latino | |||||||||
| n (%) | 0 | 0 | 0 | 1 (11.1) | 2 (33.3) | 0 | 3 (8.3) | 0 | 3 (6.3) |
| Not Hispanic or Latino | |||||||||
| n (%) | 6 (100) | 6 (100) | 6 (100) | 8 (88.9) | 4 (66.7) | 3 (100) | 33 (91.7) | 12 (100) | 45 (93.8) |
| Race | |||||||||
| Asian | |||||||||
| n (%) | 0 | 0 | 0 | 0 | 0 | 1 (33.3) | 1 (2.8) | 0 | 1 (2.1) |
| Black or African American | |||||||||
| n (%) | 0 | 1 (16.7) | 0 | 0 | 0 | 0 | 1 (2.8) | 0 | 1 (2.1) |
| White | |||||||||
| n (%) | 6 (100) | 5 (83.3) | 6 (100) | 9 (100) | 5 (83.3) | 2 (66.7) | 33 (91.7) | 12 (100) | 45 (93.8) |
| Native Hawaiian or Other Pacific Islander | |||||||||
| n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Australian Aboriginal or Torres Strait Islander | |||||||||
| n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| American Indian or Alaska Native | |||||||||
| n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Other | |||||||||
| n (%) | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 1 (2.8) | 0 | 1 (2.1) |