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In the 50 64 y age group, 134 subjects were enrolled (site 1, n = 68; site 2, n = 66) and completed the study; all were included in the evaluable immunogenicity population (n = 134).
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PERCH sites will recruit a minimum of 25 controls per month, and in months with >25 cases enrolled, sites will enroll additional controls for a 1 1 ratio for that month.
A treatment-by-enrollment sequence was observed at both small (≤8 patients) and high (>8 patients) enrolling sites (data not shown).
The genetic participation rate varied across enrolling sites, ranging from 40%to100%0%.
The Institutional Review Boards of the study coordinating center, the Fred Hutchinson Cancer Research Center/ University ofWashington Cancer Consortium, and all of enrolling sites, approved the study, and participants provided written consent.
There were 5 independent study sites: site 1 enrolled 19 patients, site 2 enrolled 15 patients, site 3 enrolled 13 patients, site 4 enrolled 12 patients, and site 5 enrolled 14 patients.
The median number of patients enrolled per site was eight.
Table 1 displays the number of participants enrolled per site.
The mean number of subjects enrolled per site for each study day was 2.4.
The mean number of patients enrolled per site was 5.0 (range per country from 1.3 to 11.1).
However, subgroup analyses did not detect an interaction between treatment effect and the number of patients enrolled per site.
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