Correction
Following publication of the original article [1], the authors reported that additional file 10 contained a typing error in the table “Percentage of responders (≥50% max TOTPAR) over two, four, six and eight hours (single-dose phase) (ITT Population)”. The table is to be read as follows:
DKP/TRAM(N = 152) | DKP (N = 151) | TRAM (N = 150) | Placebo (N = 153) | ||
|---|---|---|---|---|---|
TOTPAR2
| Responder, n (%) | 91 (60) | 69 (46) | 58 (39) | 50 (33) |
Non-Responder, n (%) | 60 (40) | 82 (54) | 91 (61) | 103 (67) | |
Treatment comparisons p-value | |||||
DKP/TRAM vs. DKP | 0.011 | ||||
DKP/TRAM vs. TRAM | <0.001 | ||||
DKP vs. Placebo | 0.020 | ||||
TRAM vs. Placebo | 0.258 | ||||
TOTPAR4
| Responder, n (%) | 99 (65) | 80 (53) | 65 (43) | 49 (32) |
Non-Responder, n (%) | 52 (34) | 71 (47) | 84 (56) | 104 (68) | |
Treatment comparisons p-value | |||||
DKP/TRAM vs. DKP | 0.026 | ||||
DKP/TRAM vs. TRAM | <0.001 | ||||
DKP vs. Placebo | <0.001 | ||||
TRAM vs. Placebo | 0.038 | ||||
TOTPAR6
| Responder, n (%) | 105 (69) | 72 (48) | 64 (43) | 49 (32) |
Non-Responder, n (%) | 46 (30) | 79 (52) | 85 (57) | 104 (68) | |
Treatment comparisons p-value | |||||
DKP/TRAM vs. DKP | <0.001 | ||||
DKP/TRAM vs. TRAM | <0.001 | ||||
DKP vs. Placebo | 0.005 | ||||
TRAM vs. Placebo | 0.050 | ||||
TOTPAR8
| Responder, n (%) | 100 (66) | 72 (48) | 66 (44) | 47 (31) |
Non-Responder, n (%) | 51 (34) | 79 (52) | 83 (55) | 106 (69) | |
Treatment comparisons p-value | |||||
DKP/TRAM vs. DKP | 0.001 | ||||
DKP/TRAM vs. TRAM | <0.001 | ||||
DKP vs. Placebo | 0.002 | ||||
TRAM vs. Placebo | 0.015 | ||||
TOTPAR: total pain relief; % max TOTPAR: percentage of the theoretical maximum possible TOTPAR; ITT: intention-to-treat; DKP/TRAM: dexketoprofen trometamol/tramadol hydrochloride 25 mg/75 mg; DKP: dexketoprofen trometamol 25 mg; TRAM: tramadol hydrochloride 100 mg; N: number of patients; n: number of patients with data. The ITT population included all patients randomised; response was defined as the achievement of at least 50% of the maximum possible TOTPAR within the respective treatment arm; TOTPAR was calculated as the time-weighted sum of the pain relief (PAR) scores; PAR was measured on a five-point verbal rating scale (VRS) (0 = none, 1 = slight, 2 = moderate, 3 = good, 4 = complete); the percentage of PAR responders was analysed using a chi-square test.
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