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The primary outcome was the change from baseline in the frequency of mixed and obstructive apneas and hypopneas.
The primary efficacy end point was mean change from baseline in the frequency of headache days for the 28-day period ending with week 12.
Fig. 5 Percentage of patients with at least a 50% decrease from baseline in the frequency of headache days across all time points and at 12 weeks in BoNTA and placebo treated.
CM-MO treatment was considered successful when the improvement, obtained after BoNT-A - preceded or not by detoxification - resulted in more than 30% decrease from baseline in the frequency of headache days at the 12 month control.
A significantly greater percentage of onabotulinum toxin A-treated than placebo-treated patients had at least a 50% decrease from baseline in the frequency of headache days when both headache days at 12 weeks (Z = −2.915; p = 0.004) and that across all time points (Z = 2.121; p = 0.034) were considered (Fig. 5).
Other efficacy analysis included the incidence of subjects with no less than 50% decrease from baseline in the frequency of headache days for the 28-day period ending with week 12 (primary end point) and during the whole observed period from 4 to 12 weeks.
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The secondary endpoints included the change from baseline in the frequencies of migraine days, moderate/severe headache days, headache episodes, migraine episodes, and acute headache medication intakes, as well as the change from baseline in total cumulative hours of headache on headache days and the percent of patients with severe (≥60) HIT-6 score.
The full-band of the regional cerebral blood flow signal is dominated by baseline changes in the frequency range from 0 to 0.05 Hz on which low-frequency vascular fluctuations (LF-VF) (0.05 0.1 Hz) and high-frequency vascular fluctuations (HF-VF) (0.5 10 Hz) are superimposed.
Therefore we applied the beamformer to 35 45 Hz activity occurring 220 280 ms and 540 600 ms pre-response, relative to an intervening 370 430 ms baseline in the same frequency range.
Furthermore there were differences at baseline in the recorded frequency of smoking which made it more difficult to show improvement in this risk factor the control group.
Mann–Whitney U tests revealed a statistically significant difference at baseline in the total frequency of services use by parents in the intervention group who scored below the BDI II [ 24] clinical cut-off and parents who scored above the BDI II [ 24] clinical cut-off U = 351, z = −3.47, p < .05.05
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