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Primary efficacy parameters were: attack frequency and aura frequency reduction.
There were no differences among groups in other efficacy parameters.
Baseline between-group comparability with respect to demographic variables and efficacy parameters were assessed.
These are mainly the vaccine efficacy parameters, together with the age-specific incidence rate of diarrhoea.
The baseline phase also served as a baseline for the evaluation of efficacy parameters.
Secondary efficacy parameters were pain intensity, pain duration and aura duration reduction.
The 8 patients ≥65 years old did not present a significant reduction of efficacy parameters vs younger patients.
Other efficacy parameters, including changes from baseline in FVC, DLCO, and HRCT/fibrosis score, were exploratory endpoints.
Clearly, the parameter τ has similar effect as the drug efficacy parameters (varepsilon_{1}) and (varepsilon_{2}).
A positive treatment effect with entacapone was also seen with all secondary efficacy parameters, including QoL.
However, previous studies revealed equivocal results depending on study design and efficacy parameters.
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