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DAS28: Multi-level repeated measures analysis, including minimisation factors and baseline DAS28 in addition to treatment.
The minimisation factors will be fractures involving either tuberosity and centre.
Multivariate linear regression will be used to adjust for minimisation factors.
*Adjusted difference between treatment groups for baseline blood pressure and minimisation factors.
When interactions between factors were included as minimisation factors, there was no major reduction in the balance overall.
For binary outcomes, if the number of events allows, the analysis will adjust for the minimisation factors.
Similar(13)
It may be a useful minimisation factor when setting up further randomised clinical trials in mesothelioma.
If pazopanib is permitted, then an additional minimisation factor will be required, as well as a recalculation of the QALY powering of the trial.
The minimisation (design) factors will also be included as fixed effects.
Treatment is primarily based on non-pharmacological measures including information, minimisation of trigger factors, physiotherapy including posture correction and instruction about active exercises, and stress and pain management.
Sensitivity analyses will be performed adjusting for minimisation and prognostic factors and by trial (FOXFIRE/SIRFLOX) in a multivariate analysis framework.
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