Fig. 1

Study CONSORT flow diagram. Participant flow with the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome. Five patients in the ITT population received incorrect kit study treatment: *one patient was randomized to receive DKP (first dose placebo) but received DKP/TRAM (first dose placebo) instead; † one patient was randomized to receive DKP/TRAM (first dose active) but received TRAM (first dose active) instead; ‡ one patient was randomized to receive DKP (first dose active) but received TRAM (first dose placebo) instead; § one patient was randomized to receive TRAM (first dose placebo) but received DKP (first dose active) instead; ¶ one patient was randomized to receive TRAM (first dose active) but received DKP (first dose active) instead. ** Received at least one dose; alloc. allocated, 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; DKP/TRAM dexketoprofen trometamol/tramadol hydrochloride 25 mg/75 mg, DKP dexketoprofen trometamol 25 mg, TRAM tramadol hydrochloride 100 mg; n: number of patients