Approvals

The study is conducted in accordance with the Declaration of Helsinki and was approved by the Danish Ethics Committee (H-B-2008-093) and the Danish Data Protection Agency (2008-41-2599).

The study is conducted and monitored in accordance with the requirements of Good Clinical Practice (GCP) as defined in Guidelines, EU Clinical Trials Directive (2001/20/EC), and EU GCP Directive (2005/28/EC).

All study participants must sign approved informed consent forms prior to any study-related procedures. The confidentiality of all study participants will be protected in accordance with GCP Guidelines.