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The executive committee will be responsible for high-level decisions affecting the running of the trial (eg, closure of study sites, response to emerging safety issues), and will convene quarterly or more frequently, as required.
Although a well organised effort was made to follow up the patients every 6 months who completed treatment, an attempt was also made to follow up defaulters at the closure of study, who defaulted for various reasons and their clinical condition was assessed.
Similar(58)
In addition, 2 (5.7%) participants in the VivaGel® arm and 4 (21.0%) in the placebo arm did not take all 28 doses due to product discontinuation by study staff; 3 due to early closure of the study, and 3 due to protocol deviations by study staff (Table 2).
Following closure of this study, we adopted the chemoradiotherapy regimen used in 0099 as our standard of practice.
Before the early closure of this study, five patients were enrolled, of whom four were evaluable for toxicity/feasibility.
Severe difficulties with recruitment were encountered, leading to premature closure of the study.
At closure of the study, dead or alive status was recorded for all patients.
All investigators remained blind to this schedule until closure of the study.
All endpoints and SAE will be finally evaluated before closure of the study.
With these doses, activity appeared no better than expected, which prompted early closure of the study.
All data will be held for 15 years after closure of the study.
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