Table 1.
Baseline Demographic Characteristics of the Study Population
| Overall population |
Immunogenicity subset (Parent study; PPS) |
Extension study (FAS) |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Zagreb group (n = 549) | Essen group (n = 275) | P value | Zagreb group (n = 69) | Essen group (n = 70) | P value | Zagreb group (n = 104) | Essen group (n = 96) | P value | |
| Age, mean (SD), years | 38.2 ± 7.1 | 39.3 ± 6.9 | 0.24 | 38.5 ± 7.2 | 40.5 ± 6.3 | 0.09 | 39.5 ± 7.3 | 41.4 ± 6.5 | 0.054 |
| Weight, mean (SD), kg | 68.2 ± 10.9 | 68.9 ± 11.7 | 0.39 | 68.2 ± 10.5 | 71.9 ± 13.4 | 0.07 | — | — | — |
| Height, mean (SD), cm | 162.7 ± 7.4 | 162.4 ± 8.2 | 0.63 | 163.4 ± 7.6 | 165.0 ± 9.1 | 0.28 | — | — | — |
| Males, n (%) | 226 (41.4) | 121 (44.0) | 0.44 | 28 (41.1) | 37 (56.9) | 0.15 | 65 (62.5) | 54 (56.25) | 0.37 |
| Asian, n (%) | 549 (100) | 275 (100) | 1.0 | 69 (100) | 70 (100) | 1.0 | 104 (100) | 96 (100) | 1.0 |
PPS: per protocol set; FAS: full analysis set.