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To determine if miRNA expressions were related significantly to overall and disease-free survival of patients (endpoint of cancer-specific death and relapse, respectively), we performed several analyses.
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Marked differences in patient endpoints were evident across sites (Table 2).
For purposes of the PSQI, the safety population included only those patients at endpoint with a valid endpoint PSQI measurement (n = 402).
We considered DMFS of BC patients as endpoint for the "IJB95/96" and "JNIadj" data sets and PFS as endpoint for the "JNImeta" data set.
Using data from all 131 patients with endpoint data, the unadjusted difference in adherence was 14%.
All patients whose endpoint was not liver disease diagnosis were censored in the model.
In addition, patients whose endpoint CDRS-R total score was ≤ 28 were considered "remitted".
Follow-up data was obtained following the operations for all patients; the endpoint of the follow-up was set at the patients' death.
Although IQWiG considered SVR irrelevant, G-BA decided to accept SVR as a patient-relevant endpoint, demonstrating inconsistency in the interpretation for patient relevance.
Overall survival rate was identified as the only valid patient-relevant endpoint; no valid surrogate endpoint was identified.
For validation, usually a meta-analysis is required, which investigates the effects of an intervention on both the surrogate outcome and the patient-relevant endpoint of interest [19],[19].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com