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Follow-up visits are completed ± 2 month of the scheduled visit date (Table 2).
The primary outcome for the study will be analyzed using an intent-to-treat strategy, where data for all participants who meet the inclusion/exclusion criteria will be included in the analysis, regardless of how many home visits are completed.
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Mid-point reliability visits were completed with each data collector and the "gold standard" rater or the author to ensure inter-rater agreement continued to exceed 80% agreement within one scale point.
In total, 1,434 of 1,568 (91%) scheduled visits were completed.
A similar number of follow up visits were completed among children allocated to either vaccination (4,958 visits among FFM ME-TRAP vaccinees vs 5,130 among controls), and a similar number presented for assessment of fever between visits (1,086 among FFM ME-TRAP vaccinees vs 1,095 among controls), p = 0.58).
All visits were completed within 4 – 28 days.
Final visits were completed between September and December 2005.
Study visits were completed at baseline, and follow-up visits three and six months later.
For this reason, the majority of telephone follow-up visits were completed by the Program Coordinator.
During the first six months of the program, only about 50% of scheduled visits were completed.
Baseline visits were completed by 45.7% of the eligible cohort (5,294 visits/11,592 subjects).
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