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Adherence in the VivaGel® group was higher than in the placebo group at the Kisumu site, contributed in part by the early closure of the study and the discontinuation of study product in a greater proportion of those randomized to the placebo arm.
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).
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.
With these doses, activity appeared no better than expected, which prompted early closure of the study.
Similar(29)
By the closure of this study, 4 of the 28 children had undergone the 5-year gait analysis and none of them were in need of bone surgery for corrections in the transverse plane.
The number of mutation carriers with invasive breast cancer that had been identified in those studies before closure of the present study was 145.
The CQC has recently undergone significant changes to its primary care services team and undertaken a national consultation on monitoring in GP practices which concluded after the closure of this study.
For each EPIC study center, closure dates of the study period were defined as the latest dates of complete follow-up for both cancer incidence and vital status (dates varied between centers, from June 1999 to December 2003).
For each EPIC centre closure dates of the study period were defined as the latest dates of complete follow-up for both cancer incidence and vital status (dates varied between centres, from June 1999 to January 2003).
More suggestions(19)
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