Jessie, Interesting document.
Inclusion Criteria = "Subjects judged as negative for influenza virus infection using a specified diagnostic kit"
Candidates in trial were pre-exposed to infection - but before development of symptoms (blood temp checked) or judged as negative to infection with above kit. I presume kit meassures antibodies to influenza.
What if the diagnostic kit is fallible? ie - candidate has had sufficient exposure for influenza development but cannot be detected at outset of trial?
If 50% of candidates in this category and other 50% were prevented then we have an exceptionally good result.
Is this possible??
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- Ann: Phase III prophylaxis trial for CS-8958
Ann: Phase III prophylaxis trial for CS-8958 , page-23
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