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All tumor assessments after baseline will be done within +/−7 days of the scheduled visit.
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Baseline evaluation will be done in ED or PU before discharge.
The baseline visit will be done and then the patient will be scheduled for the next visit.
The baseline blood draw will be done after an overnight fast of at least eight hours.
The primary response variable, change in MADRS-score between baseline and endpoint, will be done with the two-sample t-test at the significance level α = 0.05.
UNICEF is supporting a baseline survey that will be done in 2013 to assess the age range of children with different types of disabilities attending mainstream education and SERCs in eight selected provinces.
Separate baseline, efficacy, and safety analyses will be done for the induction and maintenance phases of the study.
Assessments will be done at baseline, 3, 6 and 12 months after beginning of the interventions.
Data collection will be done at baseline and at each follow-up interview using standardized questionnaires.
This procedure takes 3 minutes and will be done at baseline and at the final visit.
For practical reasons, selection and randomization of all eligible patients will be done at baseline.
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