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A Data Monitoring Committee (DMC) supervised the conduct of the study by an ongoing review of unblinded safety and main efficacy parameters.
A data monitoring committee supervised the conduct of the study by an ongoing review of unblinded safety and main efficacy parameters.
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Primary efficacy parameters were: attack frequency and aura frequency reduction.
The primary efficacy parameter was a responder analysis at study end.
In 2000, pain-free after 2 h was recommended as the primary efficacy parameter by IHS.
Tumor response was the primary efficacy parameter.
The primary efficacy parameter is pain relief.
The primary efficacy parameter was the HbA1c change.
The influence of additional adverse events is only included via the main efficacy and benefit parameters as used in the PLATO trial.
The main safety and efficacy parameters for the treatment groups were compared at baseline, using analysis of variance (ANOVA) or Kruskal-Wallis test according to the variable distribution for quantitative parameters, and the Fisher's exact test when relevant.
Three parameters are specified as main efficacy outcomes in the study protocol: change in waist circumference, change in subscapular skinfold thickness and change in endurance performance during a 6-min run; changes are measured as difference between follow-up measurement and baseline measurement.
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