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This is a randomized, multi-center, double-blind Phase II study, the primary goal of which is to evaluate the safety and efficacy of the drug vs. placebo. The study participants include volunteers with atherosclerosis in the blood vessels of the lower limbs. All in all, 360 patients were enrolled in 21 sites in Russia.
For completing the review of data is a Russia-based vendor Data MATRIX was selected, who provide top-tier data management services that ensure integrity, accountability and speed from database build development to database lock.
OCT is responsible for the all major activities within the project, including site selection, project management, clinical monitoring and final report preparation.
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