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In all three trials, allocation concealment was either inadequate or unclear.
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The trial allocation remained blinded throughout the process.
They are given the trial allocation by telephone.
Trial allocation will be concealed from this person.
The electronic and manual searches were done blind to trial allocation status.
As this is a pragmatic trial, allocation will be single blinded with outcome analyses conducted blinded to treatment allocation.
For other trials, it was unclear whether this was adequate, and for one trial, allocation concealment was not considered adequate.
If such an error occurs, participants will be analysed according to their trial allocation on an intention-to-treat basis.
It was also unclear whether participants randomised to early or delayed delivery would comply with the trial allocation.
As there were no significant effects from the trial intervention, patients within the OSCAR trial were pooled for these secondary analyses regardless of trial allocation [ 24].
Owing to the nature of the intervention and the production of an agenda, it will not be possible to blind health professionals or patients to trial allocation.
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