For each primary and secondary variable, comparisons between trea

For each primary and secondary variable, comparisons between treatment groups were made by analysis of covariance of change from baseline, with the same variable’s baseline value as a covariate, with main effects of treatment group and acute pain

medication overuse strata. The baseline covariate adjustment was prespecified as the primary analysis. Missing data were imputed using selleck compound a prespecified modified last-observation carried forward methodology (mLOCF) previously described.32,33 For binomial variables, the between-group comparisons were performed with Pearson’s chi-square or Fisher’s exact tests, except that logistic regression with baseline covariate was used for variables with baseline imbalance. This a priori planned analysis corrected for the baseline imbalance. A 2-sided test with P ≤ .05 was considered to be statistically significant. Safety analyses were performed on all randomized patients who received at least 1 dose of study medication at day 0. Contributors.— All authors formed the core writing team for the manuscript and contributed to study conception, design, data analysis, and interpretation. C.C.T., R.E.D., and M.F.B. also provided administrative support and were involved in the collection and/or assembly of data for the PREEMPT trials. S.K.A., S.D.S., Opaganib chemical structure R.B.L., and H.C.D. provided patients

for the PREEMPT trials. All authors contributed to and commented on the manuscript draft and gave their final approval to submit for publication. Demographic and Baseline Headache Characteristics.— A total of 3333 patients were screened for the PREEMPT studies, with 1384 patients randomized and thus included in

the pooled analyses (n = 688 onabotulinumtoxinA; n = 696 placebo). At baseline, there were no notable differences between the pooled treatment groups for most of the important demographic characteristics (Table 1). However, at baseline the onabotulinumtoxinA group compared with the placebo group on average had significantly 上海皓元医药股份有限公司 fewer headache episodes (12.2 vs 13.0; P = .004) and migraine episodes (11.4 vs 12.2; P = .004), and significantly more total cumulative hours of headache occurring on headache days (295.9 vs 281.2; P = .021) (Table 1). Most patients overused acute pain medications during the 28-day baseline; however, very few (1.7%) had opioid overuse. The rate of patient compliance in reporting diary data was high both at baseline (>99%) and throughout the 24-week double-blind phases (>93%). There was no difference in diary compliance between treatment groups. Primary Variable: Frequency of Headache Days.— There was a large mean reduction from baseline in the frequency of headache days in both treatment groups.

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