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The main efficacy variable was the difference in GIR level after an 8-week period of treatment.
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Main efficacy variables included: headache days/month, medication intake/month, MIDAS, HIT-6, SDS, FSS, HADS-A/D scores.
The main efficacy variables were clinical and microbiological outcome at day 7. Analyses on both valid patients and intention-to-treat populations were performed.
The three main hypotheses of the primary efficacy variable (APID between the baseline pain assessment and the mean of the 3-hour and 5-hour actual pain assessments after the first dose of study medication) were tested in sequence.
Response rate was the primary efficacy variable.
The primary efficacy variable was morning PEF.
The primary efficacy variable was MAP.
The primary efficacy variable was HbA1c concentration.
The results for all secondary efficacy variables were well in line with the primary efficacy variable.
The primary efficacy variable was POM after 48 h.
The primary efficacy variable was A1C level at Week 24.
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