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An important difficulty in defining or identifying biomarkers is the evaluation of the endpoint of the actual responses of the patients.
This may result in an inaccurate evaluation of the endpoint of an episode, with the misclassification of an insufficient increase as a full repair.
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The prespecified statistical hierarchical testing strategy, jointly agreed by the FDA and the investigators, included a stepwise evaluation of the endpoints.
There will be an interim analysis after the 1-year follow-up visit of the last enrolled patient which includes the evaluation of the primary endpoint and the secondary endpoints.
Statistical evaluation of the primary endpoint as well as of the secondary endpoints BFS, QoL, overall survival and detailed safety analysis will be performed separately for each arm, for the ITT (SDR, BFS, QoL) as well as for the per protocol (PP; SDR,BFS) and the safety (SF; QoL, NCI CTC AE) population.
The evaluation of the primary endpoint was accomplished by a GEE analysis with BPF as target variable and RNFLT and age as independent variables, taking into account the history of ON.
The evaluation of the primary endpoint will start four weeks after the last patient's enrolment.
Evaluation of the primary endpoint will be performed two years after the last patient's enrolment.
He was categorized as a positive responder in the evaluation of the primary endpoint.
Evaluation of the primary endpoint will be performed two years after the last patients' enrolment.
Evaluation of the primary endpoint revealed marked differences between the groups, even though the differences did not reach statistical significance.
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CEO of Professional Science Editing for Scientists @ prosciediting.com