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Concealment of group allocation will be achieved by giving the responsibility for allocation sequence generation and group allocation to a researcher independent of the study and its investigators.
However, the actual allocation will be transmitted to the TCOD (thereby keeping the outcome assessors blinded to allocation).
The allocation will be to three options.
As this is a pragmatic trial, allocation will be single blinded with outcome analyses conducted blinded to treatment allocation.
Treatment allocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation.
To ensure good allocation concealment, random allocation will be email based and administered by the study statistician.
From 2009 this allocation will be on the basis of metrics.
This allocation will be unalterable.
Allocation will be at random.
Hence allocation will be concealed.
Random allocation will be independent and concealed.
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