Author: Jund, Rainer; Mondigler, Martin; Stammer, Holger; Stierna, Pontus; Bachert, Claus
Title: Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis Document date: 2015_1_2
ID: 3j8jcmzm_23
Snippet: General definition of population. Only the treatment arms 'placebo' and 'BNO 1016 480 mg' of the ARhiSi-1 trial were included in the combined analysis: as inclusion and exclusion criteria of ARhiSi-2 were applied for the combined analysis, patients in the ARhiSi-1 study with facial pain/pressure > 2 or MSS > 12 or MSS < 8 at inclusion were excluded from the analysis sets, as this was a violation of an inclusion criterion in ARhiSi-2. The allocati.....
Document: General definition of population. Only the treatment arms 'placebo' and 'BNO 1016 480 mg' of the ARhiSi-1 trial were included in the combined analysis: as inclusion and exclusion criteria of ARhiSi-2 were applied for the combined analysis, patients in the ARhiSi-1 study with facial pain/pressure > 2 or MSS > 12 or MSS < 8 at inclusion were excluded from the analysis sets, as this was a violation of an inclusion criterion in ARhiSi-2. The allocation of patients to the different analysis sets was done according the 'Blinded Review Meetings' of the respective ARhiSi-1 and ARhiSi-2 trials.
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