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Compliance with study medication was assessed at each study visit by questioning the subject, reviewing the diary cards, and examining the subject's drug supply.
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This study received approval by CMS and the human subjects review board at the University of Michigan.
For these reasons, this analysis was exempt from human subjects review requirements.
EC, PB and AO participated in the management of study subjects, reviewed and revised the manuscript.
Samples and data were obtained at multiple institutions after appropriate human subjects review and written consent.
All studies were approved by research subjects review board at University of Pittsburgh and University of Rochester.
Each site had approval from their local human subjects review board for their study.
CDC human subjects review classified this work as public health evaluation and control.
All subjects reviewed an Informed Consent document and gave consent prior to enrolment.
The study was approved by the human subjects review board of our institution.
This study conduct was pursuant to review and oversight by a human subjects review board in Midland, Michigan.
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