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First, the amount of mRNA that can be extracted reliably from each sample is anticipated to be near the minimum required for a microarray assay.
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No possible biases regarding the selection of sample were anticipated and the sample was representative of the reference population.
Further testing of several of these instruments or domains in larger samples is anticipated.
The minimum new sample size is anticipated to be in the order of 1125 (375 fFN positive and 750 fFN negative women), but the proportions of each will dictate the exact sample size, as it is anticipated that at least 2 fFN negative women are required to achieve the event rate predicted in 1 fFN positive woman.
The band at 633 cm−1 is the most intense negative control band and is reasonably constant for all samples, thus it is anticipated that this band is due only to a vibrational mode of a matrix component and that changes in band intensity relative to the 633 cm−1 band are due to viral vibrations.
The proposed sample size of 36 subjects is anticipated to be further reduced by follow-up attrition, resulting in an approximate final study sample of 28-31 subjects.
It is anticipated that sample collections will be completed by spring 2011, all participants will have delivered their infant(s) by summer 2011 and data collection will be completed by fall 2011.
If it is anticipated that samples may take longer than 24 hours between collection and cell inoculation then the specimen should be rapidly frozen to -70°C to maintain viable viral titre[ 4].
It is anticipated that the sample would be reduced by follow-up attrition, resulting in an approximate final study sample of 28-31 subjects.
It is anticipated that this sample size of 1316 will be obtained by 31st December 2011.
A questionnaire will be sent to everyone on the database and it is anticipated that the sample size will be approximately 1000.
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