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Participants 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service.
We used descriptive statistics to compare characteristics of patients randomised with those eligible but not randomised and to assess the balance between the trial arms at baseline.
One thousand one hundred and seven participants were randomised, with 17 withdrawing immediately post-randomisation.
All patients randomised with at least one post-randomisation measure were analysed, i.e. intent-to-treat.
After the baseline assessment, patients were individually randomised with a web based computer randomisation service to one of three groups (see below).
Setting Suburbs of Copenhagen, Denmark Participants 59 616 people aged 30-60 years randomised with different age and sex randomisation ratios to an intervention group (n=11 629) and a control group (n=47 987).
The intent-to-treat population including all patients who are randomised with study medication assignment designated according to initial randomisation, regardless of whether patients receive study medication or receive a different medication from that to which they were randomised.
The experimental design was completely randomised with 4 treatments and 2 replications.
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In all analyses below we have combined cluster-randomised with individually-randomised trials.
For community-level interventions, we searched for controlled trials (with contemporaneous controls, randomised or non-randomised, with comparator no intervention) and uncontrolled studies that collected data on outcomes before and after the intervention.
The study is cluster-randomised, with all enrolled participants in one practice randomised to one arm of the trial in order to avoid potential 'contamination' from participants randomised to different arms.
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