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A logistic regression model including treatment and baseline in the model was used for categorical secondary efficacy variables.
Primary efficacy variables were the change in lipid profile.
To detect a signal for efficacy variables in this exploratory study, the prespecified statistical tests were two-sided at alpha of 20%.
There were no efficacy variables in this study.
All these efficacy variables were assessed at baseline, 30 and 90 days after injection.
We evaluated 50% responder rate for three treatment cycles across multiple efficacy variables.
Other key efficacy variables were HAM-A anxious mood and tension scores and the anxiety subscale scores of the patient-rated Hospital Anxiety and Depression scale (HAD).
The primary efficacy variables were changes in anxiety as determined by final on-therapy HAM-A total and psychic anxiety scores and Clinical Global Impressions scale (CGI) scores.
Secondary efficacy variables included, duration of headache per day (hours), and number of days of symptomatic therapy per month.
Main efficacy variables included: headache days/month, medication intake/month, MIDAS, HIT-6, SDS, FSS, HADS-A/D scores.
Changes in all efficacy variables between T0 and T3 (mean and median values) are summarised in Table 2.
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