,
Funding for this research was provided by:
ZonMw (852001922)
Article History
Received: 6 November 2019
Accepted: 13 January 2020
First Online: 18 February 2020
Ethics approval and consent to participate
: Central ethical approval has been confirmed from the Medical Research Ethics Committee of the AUMC location AMC (approval number NL67684.018.18) on 7 February 2019 and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained. All amendments will be notified to the Medical Research Ethics Committee of the AUMC location AMC. Important protocol modifications will be reported to the local investigators. Informed consent will be obtained before the patient can be included in this study. Participants will be asked if they agree that their data will be used should they choose to withdraw from the trial. The DESIGNATION trial does not involve collecting biological specimens for storage. The sponsor has an insurance, which is in accordance with the legal requirements in the Netherlands. This insurance provides cover for damage to research subjects through injury or death caused by the study. The insurance applies to the damage that becomes apparent during the study or within 4 years after the end of the study.
: Not applicable.
: The authors declare that they have no competing interests.