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Unlike stratified randomisation, minimisation will work towards minimising the total imbalance for all factors taken together instead of considering mutually exclusive subgroups (strata).
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Minimisation will be used to ensure balance between the groups with respect to severity of encephalopathy.
The cut-off age and GRID-HAMD17 score for minimisation will not be disclosed until study completion to ensure concealment.
Adjustment for other variables will not be necessary, as the technique of minimisation will be used during randomisation, and randomisation will be stratified by site.
In addition, for centres using telephone randomisation, minimisation will be used to ensure balance between groups with respect to first or second caesarean section.
However, minimisation will be used to ensure balance between groups with respect to the most important prognostic risk factor: in-labour and not in-labour caesarean section.
Minimisation will be used to balance the potentially confounding variables of chemotherapy and treatment with Tamoxifen, aromatase inhibitors or no hormone therapy across the groups.
An illicit drugs programme using a harm minimisation strategy can work effectively alongside a sport's WADA compliant Anti-Doping Code.
Full details of the minimisation process will be published in a separate document with restricted access.
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