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Full ethical approval was gained for the study of both cohorts.
A cost utility ratio will estimate the incremental costs per Quality Adjusted Life Year gained for the study period.
The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2369/15/18/prepub No grant support was gained for the study.
The average weight gains during the study for anakinra- and placebo-treated patients were 1.3 ± 0.6 and 1.7 ± 0.8 kg (P = 0.678), respectively.
A critical part of this process was establishing whether it was feasible and ethical to implement a meaningful intervention within a randomised controlled trial (RCT) framework; key to gaining acceptance for the study was assuring stakeholders that the control arm would receive 'usual care' and that there was a prima facie case for equipoise.
We gained permission for the study from the Institute of Psychiatry, King's College London Research Ethics Committee.
KG was involved in gaining funding for the study, overall study design and interpretation of the data.
The project was discussed with local leaders to gain support for the study at each training location.
FH was involved in gaining funding for the study, overall study design and interpretation of the data and led the response to the reviewers' comments.
SS and JA was involved in gaining funding for the study, overall study design and discussions relating to the use of exposure data.
MC was involved in gaining funding for the study, overall study design and discussions relating to the use of exposure data.
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