It is estimated that it will take 16 weeks to enroll the entire cohort of subjects. An additional 8 to 12 weeks is allocated for sample analysis by Merck, followed by an additional 4 to 6 weeks for data analysis and report generation. All data (in the form of a final study report) will be submitted for review and comment by the study sponsor (appx. 4-6 weeks). Manuscript generation and submission will then follow (appx. 6-8 weeks).