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Summary........................................................................................................................... 1 Table of Contents................................................................................................................ 2 Collaborators...................................................................................................................... 3 Study Design...................................................................................................................... 4 Analytical Method................................................................................................................ 4 Method Performance ........................................................................................................... 5 Safety Considerations........................................................................................................ 51 Comments from Collaborators ............................................................................................ 51 Conclusions ...................................................................................................................... 52 Acknowledgements ........................................................................................................... 52 References ....................................................................................................................... 52

2011.14 (APRIL 2017) - MTE-01/03

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