N | DKP/TRAM | DKP | TRAM | Overall |
---|
SDP placebo | SDP active | All | SDP placebo | SDP active | All | SDP placebo | SDP active | All |
---|
ITT population | 51 | 152 | 203 | 51 | 151 | 202 | 51 | 150 | 201 | 606 |
Safety population | 52 | 151 | 203 | 50 | 152 | 202 | 51 | 150 | 201 | 606 |
PP population | 43 | 127 | 170 | 42 | 129 | 171 | 40 | 124 | 164 | 505 |
-
N number of patients, DKP/TRAM dexketoprofen trometamol/tramadol hydrochloride 25 mg/75 mg, DKP dexketoprofen trometamol 25 mg, TRAM tramadol hydrochloride 100 mg, SDP single-dose phase, ITT intention-to-treat, PP per protocol. The ITT population included all patients randomised; the safety population included all patients randomised who received at least one dose of study treatment; the PP population included all ITT patients with no major protocol violations