Funding for this research was provided by:
HEALS project by DG Research (Grant agreement No.: 603946, Grant agreement No.: 603946)
EmeraMed (None, None)
Received: 7 August 2017
Accepted: 29 January 2018
First Online: 14 February 2018
Ethics approval and consent to participate
: The study protocol and study informed consent forms (ICF) were submitted to the Institutional Review Board (IRB) of the Universidad de San Francisco de Quito, Diego de Robles y Vía Interoceánica, Quito, Ecuador for review. After requested revisions the study protocol and ICF were approved in writing on 26 May 2015. The Regulatory Authorities required revisions and protocol (amendment 2) and ICF were therefore re-submitted to the IRB and approved on 27 Jul 2015.The study protocol was amended once during the study (amendment 3, see Additional fileInternalRef removed) to protocol. The amendment, including ICF was submitted to the IRB and approved on 30 September 2015.The study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Conference on Harmonisation/Good Clinical Practice and applicable regulatory requirements on Bioethics.
: Not applicable.
: EmeraMed Ltd. reimbursed the author’s (Paul Schutzmeier) expenses connected with the project and the publication. The authors declare that they have no competing interests.
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