Clinical data, for example, urodynamic parameters, 3-day bladder diary outcome and questionnaire scores, will be statistically analysed and compared between groups using IBM's Statistical Package for the Social Sciences (SPSS) V.19.0 or newer (Armonk, New York, USA) and will be presented with means and SDs or with medians and IQRs as appropriate.
Three trials of comparisons with oral prophylactic agents independently reported no significant between group differences for a variety of diary data outcomes but meta-analysis was not possible.
The baseline visit included an explanation of the accelerometer along with a PA recall diary (see outcomes measures for detail).
For each of the diary derived outcomes, however, we included only diaries in which all the items relevant to the calculation of the given outcome were completed.
The e-diary hypoglycemia outcome questionnaire was also accessible to the patient for entry of hypoglycemia events that were not associated with an SMBG measurement.
Information on physical activity and exercise of all patients will be obtained from the physical activity questionnaire, recordings of the accelerometer and cost-diaries (see outcome measures).
Nearly a third of our cohort had other headaches in addition to CM, all carefully phenotyped by headache specialists and all recorded in separate headache diaries to allow outcomes to be differentiated.
To allow for within participant correlation in the four day food diary, the diet outcome regression analyses were fitted with random intercept models using maximum likelihood estimation.
Relapse rate at late follow-up (LFU-1) 6 months after the start of treatment, and time to relapse; exacerbation rate at late follow-up (LFU-2, one year after start of treatment), and time to next exacerbation; clinical cure rate at the EOT visit and clinical cure rate at the TOC visit (both determined by patient-reported outcome (diary cards).
Outcomes: headache diary; PedMidas and CBCL 6-18 questionnadverseadveventsvents and unpleasant aspects; level of total self perceived satisfaction of the patient and the parents.
