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The primary analysis is performed based on the full analysis set; to assess the impact of major protocol deviations, the analyses of the primary endpoint described above will also be performed for the per protocol set.
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This will be done using the same methods as for the primary endpoint as described above.
The primary endpoint will be described using frequencies and percentages with a 95% confidence interval (95% CI), and it will be compared between the groups using the Fisher exact test.
The primary endpoint was to describe the incidence of sepsis in children with CDH.
The primary endpoint is to describe the pharmacokinetics of gentamicin administered intraperitoneally in PD patients with peritonitis based on serial blood and dialysate drug levels.
Primary endpoint of the analysis described here was the impact of TIMP-1 and CAIX alone and of each marker in correlation to the presence of CTC.
Post-treatment survival to the primary endpoint of VT/VF was described by Kaplan-Meier cumulative estimates, with comparison performed by the log rank test.
Therefore, the criteria for recurrence, the primary endpoint of this RCT, were described in detail.
Continuous variables defined in the protocol as safety were analyzed on the safety population as absolute change from baseline to end of treatment or end of follow-up using ANCOVA model as described for primary endpoint.
Time-to-event endpoints will be analysed as described for the primary endpoint.
Analyses of secondary endpoints were performed as described for the primary endpoint.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com