Patient demographic and baseline characteristics by treatment group (ITT population)
| Demographic and baseline characteristics | TRAM/ DKP, n=260 | TRAM/ paracetamol, n=262 | Placebo, n=131 |
| Race (n, %) | |||
| Asian | 14 (5.4) | 21 (8.0) | 6 (4.6) |
| Black or African American | 7 (2.7) | 3 (1.1) | 6 (4.6) |
| White | 235 (90.4) | 233 (88.9) | 118 (90.1) |
| Other | 4 (1.5) | 5 (1.9) | 1 (0.8) |
| Gender (n, %) | |||
| Female | 152 (58.5) | 158 (60.3) | 78 (59.5) |
| Male | 108 (41.5) | 104 (39.7) | 53 (40.5) |
| Age (years) | |||
| Mean (SD) | 26.8 (7.48) | 27.1 (8.13) | 26.5 (7.67) |
| Range | 18–52 | 18–63 | 18–59 |
| Body mass index | |||
| Mean (SD) | 23.5 (4.48) | 23.4 (4.36) | 23.7 (4.21) |
| Range | 16–44 | 15–44 | 16–40 |
| Pain intensity (NRS-PI) | |||
| Mean (SD) | 5.7 (1.4) | 5.5 (1.3) | 5.6 (1.3) |
| 4≤ NRS-PI ≤6 (n, %) | 196 (75.4) | 210 (80.2) | 102 (77.9) |
| NRS-PI >6 (n, %) | 63 (24.2) | 52 (19.8) | 29 (22.1) |
4≤ NRS-PI ≤6 corresponding to moderate pain intensity; NRS-PI >6 corresponding to severe pain intensity.
ITT, intention to treat; NRS, Numerical Rating Scale; TRAM/DKP, tramadol/dexketoprofen.