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Repeated measure analyses of binary endpoints will be analysed using generalised estimating equations methods which do not require imputation of missing values, provided the data are ignorable missing.
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Binary secondary endpoints will be analysed using logistic regression models.
All endpoints will be assessed at baseline and postintervention (16 weeks).
That's what leads to the fight for the endpoint — how people protect endpoints will be completely different than over the last two or three decades.
Time-to-event endpoints will be analysed as described for the primary endpoint.
Study endpoints will be assessed by an independent endpoint adjudication committee (EAC) (Appendix F).
All secondary efficacy endpoints will be analysed as described for the primary efficacy endpoint.
Additional secondary endpoints will be analyzed in the ISM group.
The diagnosis of endpoints will be made by the Endpoint Committee.
All secondary endpoints will be analysed on the cluster level.
Secondary endpoints will be evaluated on 7 postintervention visits.
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