Table I.
Demographic characteristics of volunteers
| Parameter | OAC | OCF | OBAM | OBTM | Total |
|---|---|---|---|---|---|
| Total number (ITT*) | 100 | 100 | 100 | 100 | 400 |
| Included per-protocol (PP) | 98 | 95 | 94 | 90 | 377 |
| Female, n (%) | 43 (43.9) | 50 (52.6) | 43 (45.7) | 43 (47.8) | 179 (47.5) |
| Male, n (%) | 55 (56.1) | 45 (47.4) | 51 (54.3) | 47 (52.2) | 198 (52.5) |
| Age range (mean ± SD) [years] | 10–70 (40 ±13.1) | 14–80 (41 ±13.18) | 16–73 (38 ±11.79) | 15–79 (39 ±12.53) |
*
Intention to treat. There was no significant difference between the groups regarding sex and age distribution (p = 0.65%).