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Standard adjustment of analyses according to eventual differences between groups at baseline will be made if necessary.
Time point-specific comparisons between the groups of the changes with respect to baseline will be made based on this model.
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Baseline assessments will be made 1-2 weeks before program commencement.
Adjustments for baseline scores will be made and interactions with age and gender will be studied.
If necessary, corrections for baseline differences will be made during analysis.
After inclusion, an appointment for the baseline measurement will be made.
If necessary, adjustment for baseline variable will be made, using analysis of covariance (ANCOVA).
A description of baseline characteristics will be made between those randomised to the control and intervention groups.
Simple comparisons of the baseline characteristics will be made among the participants and non participants of the cohort.
All baseline measures will be made prior to group allocation and follow up measures will be subject to a strict protocol with researchers blind to group allocation.
For binary outcomes (notably the primary outcome), no baseline adjustment will be made because of issues relating to the non-collapsibility of ORs.
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