Data Analysis and Statistical Analysis
Headache, headache
SECONDARY
All absolute values are presented as mean ± standard deviation (SD). Headache intensity and duration scores are presented as median (range). Calculation of sample size was based on detection of a difference between treatments in headache incidence of 80% on the placebo day and 20% on the glibenclamide day at a 5% significance level with 80% power. R statistical software (version 4.2.1) was used to calculate the sample size, using the “power.prop.test” function and “stats” package.Sample size was calculated at 10 participants, and 15 participants were included to ensure power. The primary endpoint was difference in incidence of headache (0–12 h) between the three experimental days: levcromakalim-placebo day, levcromakalim-glibenclamide, and placebo-placebo day. The secondary endpoints were a difference in AUC for headache intensity scores (0–12 h) and HR and MABP from baseline to the last measurement between the three study days. Baseline was defined as T0 before the start of infusion.Incidence of headache was analyzed as categorical paired data using McNemar’s test. Area under the curve (AUC) was calculated according to the trapezium rule to obtain summary measures and to analyze the differences in response between the three study days. AUC was compared between study drugs using the Wilcoxon signed-rank test.Statistical analysis and graphs were performed using GraphPad Prism 8.3.0 (San Diego, CA, USA). Level of significance at five percent (