Table 3 Outcome measures and time points for application of the various outcomes (statistical calculations are further described in the Statistics section)

Primary outcomes

Difference between BI and BAU in:

a) number of headache days per month

X

b) number of headache medication days per month

X

Change relative to baseline in

a) number of headache days per month

X

b) number of headache medication days per month

X

Secondary outcomes

Difference between BI and BAU in proportion of cases without chronic headache and without medication overuse

X

Change relative to baseline in proportion of patients with more than

a) 25% reduction of headache days

X

X

b) 50% reduction of headache days

X

X

Change relative to baseline in headache index (Area under curve for headache intensity versus time)

X

X

Change relative to baseline in

a) headache days from headache diary

X

X

b) medication days from diary

X

X

Change relative to baseline in average headache intensity recorded by VAS (from headache diary)

X

X

Change relative to 3 month follow-up in self-reported health related costs

X

Change relative to 3 month follow-up in quality of life recorded as SF-36 and MIDAS/HIT-6

X

Change relative to baseline in:

a) number of headache days per month

X

b) number of headache medication days per month

X

Relapse rate compared with status at 3 month

X