Updates are available Correction dated 2016-11-21
Click to view Correction: https://doi.org/10.1007/s40262-016-0487-z
-
Authors
Bodenlenz, Manfred
Tiffner, Katrin I.
Raml, Reingard
Augustin, Thomas
Dragatin, Christian
Birngruber, Thomas
Schimek, Denise
Schwagerle, Gerd
Pieber, Thomas R.
Raney, Sam G.
Kanfer, Isadore
Sinner, Frank
-
Funding
Funding for this research was provided by:
U.S. Food and Drug Administration (1U01 FD004946-01)
- License Information
-
More Information
Article History
First Online: 18 August 2016
Compliance with Ethical Standards
:
: Funding for this project was made possible, in part, by the FDA through research award FD004946. The views expressed in this publication do not reflect the official policies of the FDA, or the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
: MB, KIT, RR, BT, TA, CD, TB, SK, DS, TRP, and FS are employees of Joanneum Research holding patents on OFM devices. SGR is an employee of US FDA. GS and IK declare that there are no conflicts of interest.
: The study was conducted with the full informed consent of all participating subjects, under the authority of the Ethical Committee of the Medical University of Graz, the Austrian health authority AGES, and the FDA’s Research Involving Human Subjects Committee (RIHSC) and was performed in accordance with Good Clinical Practice and the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. The study has been registered in the European Clinical Trials Register (EudraCT No. 2013-005062-19) and at ClinicalTrials.gov (NCT02711267).
