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The top priorities of the discontinuation plan at the Africa Centre were: 1) to disseminate the information quickly and comprehensively to trial participants, community members and stakeholders; and 2) to discontinue women from 2% PRO2000/5 gel.
The discontinuation plan will continuously be adjusted according to the individual participant.
During the taper off, we assume that the dose decay curve approximately follows an exponential function, because the discontinuation plan assumes a constant withdrawal rate.
We furthermore assume that the participants in the control group on average will be able to follow the discontinuation plan for two months (8 weeks) while the participants in the melatonin group are assumed to be able to follow the discontinuation plan for four months (16 weeks).
We assume that the trial participant, after having followed a discontinuation plan for a certain period of time, either has completed the withdrawal (intake of benzodiazepines stopped) or has paused the gradual taper and continues on a reduced dose.
We wish to be able to detect a statistically significant difference of minimum 8 weeks between the two intervention groups with regard to average duration of adherence to the discontinuation plan with 90% probability.
Similar(53)
Discontinuation before planned completion of the study implies insufficient efficacy or unacceptable adverse effects.
Discontinuation was planned to commence on the 14th February 2008 across all sites in line with the public release of the discontinuation.
No maintenance therapy with Bevacizumab after chemotherapy discontinuation was planned.
During the academic year, the team will apply advanced data analysis techniques using the DHS data and develop methods for collecting big data to provide dynamic information on contraceptive discontinuation to family planning researchers and advocates.
This Bass Connections project aims to curate available data into an online, user-friendly tool, apply advanced data analysis techniques and develop methods for collecting big data to provide dynamic information on contraceptive discontinuation to family planning researchers and advocates.
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