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We plan to analyse the OS and RFS at 5 years after the last enrolment, as described in the study protocol.
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Evaluation of the primary endpoint will be performed two years after the last patients' enrolment.
All follow-up investigations were completed at the time of data cutoff in April 2012, which was 1 year and 8 months after the last patient enrolment.
The median overall survival time was not reached when 1 year passed since the last patient enrolment, namely 18 patients were alive and 10 patients were dead, and the 1-year survival rate was 78.6% by the Kaplan Meier method (Table 3).
Maternal follow-up lasted from enrolment through pregnancy outcome.
This number exceeds the original sample size (100) because of a high number of patients appearing on the last day of enrolment.
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.
The main evaluation will be performed two years after the last patient's enrolment.
Pregnant women and women given birth in the last year before enrolment will be excluded from the study, as are patients who live and work outside a 50-km radius of the treatment location.
Enrolment lasted one year and follow-up lasted one month.
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