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We did not plan any interim analysis and did not perform any.
Without any interim analysis, no adjustment for multiple testing was necessary and the study was analysed after collection of all data.
Implementing post hoc group-sequential analysis strategies in the same way as above, i.e. comprising one (at N = 50), two (at N = 33, 67), or three interim analyses (at N = 25, 50, 75), did not lead to early termination of the study at any interim analysis (Table 3).
The basic idea is to use significance levels smaller than the nominal significance level (of usually 5%) in interim analyses in order to secure that the probability of falsely rejecting the null hypothesis at any interim analysis or at the final analysis does not exceed the nominal significance level.
We did not plan any interim analysis or early stopping.
We did not plan or undertake any interim analysis.
Similar(49)
Had this been an interim analysis, any independent safety and data monitoring committee would have recommended continued randomisation and completion of the trial (figures 2 and 3).
In Figure 1, one sees that the ETSL is fairly flat for optimal designs with interim analyses between 1.8 and 2.8 years, so any design chosen with an interim analysis between these two times will be close to optimal.
Criteria for evaluation were based on results of an interim analysis from stage 1.
Enrollment was closed prior to the target accrual, following an interim analysis and futility calculation.
Many trials, including those with mortality as an endpoint, did not appear to have any formal interim analysis, which is inadequate if we are to protect participant safety.
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