Received: 29 October 2018
Accepted: 10 September 2019
First Online: 15 October 2019
Ethics approval and consent to participate
: All participants have given written informed consent signed by the individual to participate the in the study and ethic committee approval from all participating centres was obtained for both cohorts. IRBs at each participating clinical site have approved the Icona protocol [Additional file InternalRef removed: Table S1].
: Not applicable.
: The authors declare that they have no competing interests.