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The owners answered multi-dimensional questionnaires about their dogs at seven different times: Six weeks before the first screening visit (W−8 = 8 weeks before baseline), during the screening visit (W−2 ), at the baseline visit (W0), at home once a month between visits (W4, W8, and W12) and at the end of trial-visit (W16).
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Study compliance will be assessed during the screening and baseline periods using attendance at appointments and completion of questionnaires.
This condition was not symptomatic during the screening or baseline assessment, hence was not detected before randomization.
As presented in Table 1, the retrospectively assessed frequency of SMBG during the screening visit baseline was 4.69 readings/subject/day, which was not statistically different from the subsequently observed frequency of SMBG.
For both studies, patients were required to have pain for ≥14 days of each month for 3 months prior to study entry, with a mean pain severity ≥4 on daily pain diary ratings during the screening and baseline periods.
Table 1 shows the baseline characteristics of the screening cohort.
Serum ethanol levels were obtained during the screening process, at the baseline visit and at the end of study.
Sociodemographic data and clinical data are obtained during the screening interview and via the baseline questionnaire.
Patients completed the GA-VAS during six clinic visits (screening, baseline, Weeks 1, 2, 4, and 5) and at home each night during the screening week and first week of treatment.
Baseline lipid measurements were generally a mean of at least two assessments taken during the screening period.
Baseline hs-CRP was determined as the average of all of the values during the screening period, prior to dosing on Day 1.
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CEO of Professional Science Editing for Scientists @ prosciediting.com