Document is current

Article History

Received: 5 September 2023

Accepted: 14 January 2024

First Online: 18 January 2024

Declarations

:

: I confirm that all experiments in this study will be conducted in strict accordance with the relevant guidelines and regulations, or in accordance with the Declaration of Helsinki.The IODA study was approved by the ethical committees of the four participating centers (protocol version 2– date: 30/01/2023): de Ethische Commissie Onderzoek UZ/KU Leuven (S67021) and Comité d’Ethique Hospitalo-Facultaire Universitaire de Liège (2020 − 212). If the medical doctor confirms the eligibility and the patient agrees upon participation, informed consent will be signed by both the investigator and the patient. The study will be conducted in accordance to relevant guidelines and regulations.

: Not applicable.

: The authors declare that they have no competing interests.

: Patient recruitment is ongoing in the University Hospital of Leuven, CHU Liège, Jessa Ziekenhuis, and Clinique Saint Luc Bouge 35 patients are randomized (29 pilot study + 6 full study).

: Personal data recorded on all documents will be regarded as confidential. All data will be handled and stored in accordance with the General Data Protection Regulation (GDPR) and the Data Protection Act 2018. During the clinical trial and after trial closure, adequate and accurate records will be maintained to enable the conduct of a clinical trial and the quality of the research data to be evaluated and verified. All essential documents will be stored to ensure that they are readily available, upon request, for the minimum period required by national legislation or for longer if needed.