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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).
Final visits were completed between September and December 2005.
All visits were completed within 4 – 28 days.
During the first six months of the program, only about 50% of scheduled visits were completed.
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Follow-up visits are completed ± 2 month of the scheduled visit date (Table 2).
To prevent classification and observer bias, matching of ED visits was completed with the investigator (LO) blinded to the ED diagnosis and visit details.
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.
For each participant and each follow-up visit we calculated expected visit date, date visit window opened, date visit window closed, logged whether the visit was completed, visit completion date, and made notes about the participant's status with the study and our attempts at contact.
"Talk about the Arafat-Peres meeting is postponed until the visit is completed," Mr. Shaath said.
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