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Minimisation will be used to ensure balance between the groups with respect to severity of encephalopathy.
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.
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.
Minimisation will be used to ensure balance between the groups with respect to the most important factors likely to affect later outcome, one of which is the method of cannulation (either veno-venous or veno-arterial).
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Full details of the minimisation process will be published in a separate document with restricted access.
The minimisation factors will be fractures involving either tuberosity and centre.
6 9 The minimisation variables will be included as covariates in the regression model for each outcome.
A random-deterministic minimisation algorithm will be used to produce treatment groups balanced for important prognostic factors.
If pazopanib is permitted, then an additional minimisation factor will be required, as well as a recalculation of the QALY powering of the trial.
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