Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

[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: July 31, 2008
Last updated: October 4, 2011
Last verified: NA

Responsible Party: [Redacted] Identifier: NCT00727805     History of Changes
Other Study ID Numbers: C-02-40 
Study First Received: July 31, 2008
Last Updated: October 4, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Regional Commission of Freiburg
Italy: Ministry of Health
Portugal: National Authority of Medicines and Health Products
Spain: Spanish Agency of Medicines
United States: Food and Drug Administration processed this record on December 09, 2016

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