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If a total number of N packets are selected, the probability of detecting at least one malicious packet will be given by the Bernoulli statistical trial probability [30] P detection = ∑ r = 1 N N r ( P ) r ( 1 - P ) N - r (17).
Strengths of response adaptive trial design include more efficient assessment of efficacy, limited risk of RCTs that find potential harm (by decreasing the sample size compared to frequentist statistical trial design), decreased time and expense (i.e., more efficient futility rules), improved drug dose selection and earlier completion of negative RCTs.
This is a retrospective exploratory analysis, which was not considered in the initial statistical trial design or trial sample size determination.
ML and SH conducted statistical trial planning, SH generated the random allocation sequence and concealment mechanism, reviewed and edited the manuscript, VW contributed towards recruitment and review of subjects, reviewed and edited the manuscript, AM reviewed and edited the manuscript.
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In order to obtain probability of joint failure, Monte-Carlo sampling method was used for statistical trials.
In the hierarchy of statistical trials, the RCT has been on the throne for over half a century [ 1].
Both the statistical test and the trial design we considered were modeled closely after recently completed and published trials [ 1- 3].
However, as would be expected given the diverse nature of the trials, statistical heterogeneity between trials is very high (I² statistic = 98%and97%7%, respectively).
Although none reached statistical significance, trials focusing on a general dialysis population tended to show either no effect or a benefit of greater hemoglobin level target, whereas trials enrolling cardiac patients suggested increased mortality associated with greater hemoglobin levels.
Statistical between-trial heterogeneity within each subgroup was assessed using the I2 measure with 95% CIs [ 6].
Given the clinical heterogeneity and insufficient data for statistical pooling, trials were described in a narrative way, taking into consideration methodological quality scores.
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