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Primary efficacy analyses were conducted on the ITT data set.
Where possible, we intended to use intention-to-treat (ITT) data for the primary efficacy analyses.
There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected.
Primary efficacy analyses were conducted using intention-to-treat population.
The sample size was based on primary efficacy analyses.
The results of the primary efficacy analyses from these trials have been reported elsewhere [ 14, 15].
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The treatment group comparability analysis, primary efficacy analysis, secondary efficacy analyses, and biomarker assessments were by treatment group based on the modified intent-to-treat population, consisting of randomized subjects who received at least one dose of study drug and had the postbaseline primary efficacy measurement.
The intent-to-treat (ITT) population was the a priori analysis population, but due to the considerable number of discontinuations, the per-protocol (PP) population was used for the primary efficacy and OSDI analyses, and the ITT population was used for sensitivity analyses.
To analyse the robustness of the results of the primary efficacy analysis, sensitivity analyses were performed using ANCOVA FAS, LOCFF).
Results of the primary efficacy parameter, responder analyses in Ashworth score from visit 1 to the end of the study demonstrate clinically highly meaningful changes in the INCO group compared to baseline for all clinical patterns (see Table 4).
The primary analysis and efficacy analyses were conducted in an intent-to-treat population.
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