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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.
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RESULTS: Intent-to-treat analyses revealed medium to large treatment effect sizes for all sleep diary outcomes, and very large treatment effects for insomnia severity, sleep quality, and PTSD symptoms.
ICC of the AP with the original and corrected diary outcomes was 0.98 (CI: 0.94 - 0.99).
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.
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).
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).
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).
The preferred methods of recording data were routine patient satisfaction questionnaire, patient diaries, patient reported outcome measures and patient focus groups.
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