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Article History

Received: 28 July 2020

Accepted: 27 March 2021

First Online: 20 April 2021

Declarations

:

: As mentioned above, the study received ethical approval from the Ethics Committee at each of the three sites. After providing the families with sufficient verbal and written information about the project (including all protection data procedures, the potential benefits and risks of participating in the study, and the option to disengage from the study at any point without affecting their usual clinical care), they will be asked to sign the written informed consent.The study will be conducted following the principles developed by the World Medical Association, outlined in the Declaration of Helsinki.

: Before signing in the consent form, all participant families will be provided with written information about the study. This includes the aims of the study, families’ voluntary participation, the duration of the study, the timeline of families’ participation, the potential risks and benefits of participating in the study, all data protection measures, and their consent for including anonymous study data on scientific publications.On the consent form, participants will be asked if they agree to the use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with other team members or the Incredible Years team for supervision purposes. This trial does not involve collecting biological specimens for storage.

: The views expressed in this publication are those of the authors, and they all report no potential conflict of interest.