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The main efficacy analysis of BCIRG 005 [ 35] was also presented.
The main efficacy analysis included all participants with at least one adequate CUS examination after the baseline scan.
The main efficacy analysis population was defined as a 'full analysis set (FAS)' not including patients with major GCP violations.
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The primary efficacy analysis was conducted on the observed values.
The main efficacy criterion was assessed by analysis of covariance (ANCOVA) with the product, site and sequence factors as fixed effects, the subject factor as random effect and the baseline as the covariate.
Within the imagery condition, we carried out the same mixed-model analysis as for the main efficacy analyses, with BDI-II as outcome, but included the mean vividness rating (M = 3.42, SD = 0.71) as a covariate.
However, a phase III clinical study evaluating the efficacy and safety of bevacizumab together with rituximab plus CHOP in patients with DLBCL (MAIN trial) could not be completed after a safety and efficacy analysis of the first 720 patients.
These estimations confirm a former meta-analysis by Trautmann et al. [19] which found that headache intensity was the main efficacy criteria in pediatric headaches.
Since the main objective of our article is to provide a descriptive listing of the training offered and not to conduct an efficacy analysis, we included studies that did not have control conditions.
Five subjects were excluded from efficacy analysis, three because they did not receive any injection and two because they were not evaluated for the main efficacy criterion.
Efficacy analysis set.
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