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. Author manuscript; available in PMC: 2013 Nov 7.
Published in final edited form as: Mol Nutr Food Res. 2012 Jul 20;56(9):10.1002/mnfr.201200166. doi: 10.1002/mnfr.201200166

Table 1.

Summary of the studies conducted and the primary objectives of each study.

Study name Duration
(days abstain/consume/abstain)		 Number of volunteers
(number of urine samples expected
to be collected)		 Objectives
Study 1 11 days
(3/3/5)		 n=1
(n=54, 1 PM sample during 3 abstaining days before consuming and then every urination during 3 days consuming and the following 5 days abstaining)

  1. Collect urine for methods development.

  2. Confirm ability to detect FB1, B2 and B3.

  3. Obtain preliminary 3 day kinetic data.
Study 2 14 days
(3/6/5)		 n=1
(n=25, 1 PM sample during 3 abstaining days before consuming and then 1 AM and 1 PM during 6 days consuming and the following 5 days abstaining)

  1. Determine FB1, B2 and B3 in AM and PM spot urine samples.

  2. Obtain 6 day kinetic data to compare to Study 1.
Study 3 11 days
(3/3/5)		 n=8
(n=88, 1 sample/day/volunteer)

  1. Determine inter-individual variability.

  2. Confirm clearance kinetics from Studies 1&2.

  3. Confirm ability to detect FB1, B2 and B3.

  4. Confirm spot urine sample use to estimate intake.
Study 4 Daily
(all consuming)		 n=177
(n=177, 1 sample/volunteer)

  1. Confirm method in naturally exposed population.

  2. Confirm detection of FB1, B2 and B3 in naturally exposed population.

  3. Confirm spot urine sample use to estimate intake.
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