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Mean baseline scores were similar among groups on most efficacy measures.
Although most efficacy measures were maintained at similar levels throughout the study, for most measures, the mean scores were slightly worsened at end point compared with baseline.
Across most efficacy measures, response rates and improvements were greater with apremilast 30 mg BID versus apremilast 20 mg BID, although the study was not designed to make formal efficacy comparisons.
Changes consistent with improvement in anxiety symptoms were observed on most efficacy measures for vilazodone 40-mg/day patients; greater overall improvement in illness versus placebo was suggested by statistically significant differences from placebo on the CGI-I score (vilazodone 20 and 40 mg/day) and CGI-S change (vilazodone 40 mg/day).
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The efficacy of LAIs in general, and SGAs in particular, seems to be consistently shown throughout studies where patients reported improvement on the most common efficacy measures.
A dose-dependent trend for improved efficacy with increasing lipegfilgrastim doses was apparent for most secondary efficacy measures, including DSN cycles 3 and 4, mean time to ANC nadir, depth of ANC nadir, and ANC recovery.
However, the PEG-only formulation was constantly superior for most objective and subjective parameters, including the frequency of stools which is considered the most objective efficacy measure in constipation.
The most commonly reported efficacy measures were ACR-, European League Against Rheumatism (EULAR)- and DAS28-based response criteria.
Patients receiving 8 mg VM202 per leg improved the most in all efficacy measures including a significant (P = 0.03) reduction at 3 months in the mean pain score and continued but not statistically significant reductions in pain at 6 and 9 months.
The LOCF method was not used for repeated measures ANOVA (RMANOVA), which was used to analyze most efficacy endpoints.
For clinicians, the most important indicator of efficacy was represented by the reduction in the number of days with headache, in agreement with the efficacy measures used in the clinical trials and in real-life studies evaluating OBT-A in CM [14, 15, 28, 31, 34, 35].
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