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Article History

Received: 28 August 2018

Accepted: 17 September 2018

First Online: 27 September 2018

Ethics approval and consent to participate

: This study complies with the Declaration of Helsinki and has been approved by the ethical committees of the participating hospitals in both countries, with the University Hospital Ghent (Belgium) and the Lazio 1 of San Camillo-Forlanini Hospital in Rome (Italy) as the central ethical committees. Written informed consent is obtained from all participants prior to enrolment. The HeartMan wristband has been approved by the Federal Agency for Medicine and Health products and by the Ministry of Health in Belgium and Italy respectively. Any modifications to the protocol which may impact on the conduct of the study, potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will be submitted as an amendment to the ethical committee. The study is registered at(NCT03497871).

: Not applicable.

: The authors declare that they have no competing interests.

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