reduce the rTNSS by 2 and 9, respective and that a meta-analysis SD of might be a Ubiquinone conservative esti-mate. On the basis of these valu a -sided a value of , and a 0 dropout ra randomized subjects per treatment arm were suf ient to achieve 0 power. Sample size in study MP was determined by excluding a treatment difference of less than units in overall reduction in the rTNSS over a 4-day treatment period. Allowing for dropou a minimum of sub-jects per group had to be randomized. Randomization Patients were randomized and balanced by study site in blocks of .
Eligible subjects received the study site next available randomization num-ber in sequence. Blinding Individual nasal spray bottles were identity masked such that both patients and study personnel were blind to treatment assignment. The active Cabozantinib controlsprised the individualponents of M in the same vehicl pump volum and device . A blind randomization code was maintained at a central site apart from the sponsor and study centers. Study blinding was pre-served at the study sites until all subjectspleted the study and the database had been locked. Statistical analyses A hierarchical test procedure was implemented to maintain the overall -sided type I error level of 5 among the pairwiseparisons.
As changes inbined rTNSSs werepared between patients receiving M and placebo. If this was signi a M was thenpared with azelasti and if this was also signi a it was thenpared with FP. As prespecid in trial protocols and statistical analysis plans before unblindi ef acy purchase Sodium Danshensu analyses were performed on the intent-to-treat population of all randomized patients with at least postbaseline observation. An analysis of covariance model was applied to the primary ef acy variable of absolute change inbined morning plus evening rTNSSs. The model included the treatment days from day to day 4. Fixed effects were treatment gro d and cent with baseline as a continuous covariate. The covariance matrix of the error terms was left unspecid and allowed to differ among treatment group with degrees of freedom calculated by using the Satterthwaite approximation. Treatment differences are presented as differences in least squares means resulting from this applied ANCOV to account for the applied inferential statistical methods.
Change from baseline in iTNS individual re ctive nasal symptom scor rTOS and RQLQ order Ariflo scores were assessed in the same way. The meta-analysis on ef acy data was conducted post hoc andprised all studies. The statistical models used for the meta-analysis were similar to those used in the individual studi with an additional ?xed effect for study. In additi the rTNSS was assessed based on patient severity. Patients were categorized into severity groups according to their median baseline rTNSSs or median baseline RQLQ scores . Moreov time to response was analyzed by using Kaplan-Meier estimates. A change from baseline in bined rTNSS of at least 0 7 or a score of point or less for each nasal magazine symptom were used to dee response. RESULTS Patients Studypletion rates were high and similar across studies and across treatment groups . CARR Dropout rates were negligible . When data were pooled for meta-analys and patients received M , azelasti and place respectively. The baseline characteristics of the treatment.