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Article History

Received: 10 July 2020

Accepted: 1 March 2021

First Online: 12 March 2021

Declarations

:

: The study protocol was reviewed by the Independent Ethics Committee (IEC) of Schleswig–Holstein. A positive vote was given on May 7th, 2019. The study was conducted in accordance with the ethical principles based on the current version of the Declaration of Helsinki []. It abided by the German Medical Device Law and current ISO 14155 and the applicable MEDDEV guidelines and was performed according to the standard operating procedures (SOPs) of the study site. Patient consent was obtained and documented according to the applicable regulatory requirements and adhered to GCP and to the ethical principles based on the principles of the Declaration of Helsinki []. Prior to obtaining consent, information was given in a language and at a level of complexity understandable to the patient in both verbal and written form by the investigator. Prior to participation in the study, a written consent form was signed and personally dated by each patient and by the investigator. Each patient received a copy of the signed and dated consent form.

: Not applicable.

: The authors declare that they have no competing interests.