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Article History

Received: 8 November 2023

Accepted: 22 December 2023

First Online: 15 January 2024

Declarations

:

: The trial will be performed in accordance with the recommendations guiding physicians in biomedical research involving human subjects, adopted by the 18^th World Medical Association General Assembly, Helsinki, Finland, 1964, amended by the 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996. The trial will be conducted in accordance with the UK Policy Framework for Health and Social Care Research, the applicable UK Statutory Instruments, (which include the Medicines for Human Use Clinical Trials 2004 and subsequent amendments, General Data Protection Regulation (Regulation (EU) 2016/679) and the Data Protection Act 2018) and Good Clinical Practice. This trial will be carried out under a Clinical Trial Authorisation in accordance with the Medicines for Human Use Clinical Trials regulations. Written informed consent will be obtained from all patients as described earlier. The protocol has been approved by the London - Westminster Research Ethics Committee on 19^th October 2022. Approval was initially granted by the Medicines and Healthcare Products Regulatory Agency on 24^th October 2022 and combined review from Health Research Authority on 24^th October 2022; the current protocol (v3.0) was approved on 24^th August 2023. The ARISTOCRAT Trial Office will coordinate and communicate protocol modifications and modifications to all relevant parties.

: Not applicable.

: Neither the sponsor nor funders had any role in trial design, data collection, data analysis, data interpretation or writing of the report. The corresponding author had full access to all the data in the trial and had final responsibility for the decision to submit for publication.

: JS, AP, FC, FB, LBr, PB LBi, and SCS received research funding from The Brain Tumour Charity and were provided with the nabiximols and matched placebo free of charge by Jazz Pharmaceuticals for this study. FC received an honorarium from Bayer. No other authors have any completing interests to declare.