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Table 2 Scientific strength of evidence

From: Italian guidelines for primary headaches: 2012 revised version

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The difference in the parameters of efficacy registered in studies compared with placebo or another active drug has a high level of significance (p < 0.01; p < 0.001; p < 0.0001). Adverse events are rare or occasional and not severe

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The difference in the parameters of efficacy registered in studies reaches the minimum level of significance (p < 0.05) or the minimum clinically significant level (difference in the parameters <15 %)a

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The difference in the efficacy parameters between the study drug and placebo or another active drug is not statistically significant

0

The drug is not efficacious or is characterized by severe adverse events

  1. aEven drugs for which the difference in the efficacy parameters compared with placebo or another active drug is higher than the minimum level of statistical significance, but have frequent, yet no severe adverse events are included in this group