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[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.
Information provided by:
[Redacted] Identifier:
First received: December 6, 2016
Last updated: December 7, 2016
Last verified: NA

Responsible Party: [Redacted] Identifier: NCT02988895     History of Changes
Other Study ID Numbers: SMD-201601 
Study First Received: December 6, 2016
Last Updated: December 7, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration processed this record on December 09, 2016

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