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Article History

Received: 14 July 2023

Accepted: 9 August 2023

First Online: 23 August 2023

Declarations

:

: Ethical approval has been granted by the Medical Ethical Committee region Arnhem-Nijmegen, the Netherlands on the 21st of March 2022 (NL79202.091.21). All methods will be carried out in accordance with relevant guidelines and regulations. All experimental protocols were approved by the Medical Ethical Committee region Arnhem-Nijmegen.

: Informed consent will be obtained from all subjects and/or their legal guardian(s).

: Not applicable.

: The preliminary pilot study was co-financed by Medtronic. Medtronic has no financial contribution to the EMITT trial. MtL is a board member of the Dutch Society of Neuro Oncology. This organization advises the ministry on including certain treatments in the basic healthcare package and is responsible for drawing up treatment guidelines. All other authors declare that they have no competing interests.

: Important protocol modifications will be resubmitted to the MEC and will be communicated to all investigators and trial participants as well as the DSMB and the Dutch Healthcare Institute.

: The results of the study will be disclosed unreservedly. Both positive and negative results will be submitted for publication to peer-reviewed journal. The results of the study will be presented at (inter)national meetings and will be shared with the patient association and study participants.

: This study is in the process of recruiting participants as of the 8th of April 2022.