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Whilst personal possession is not straightforwardly criminalised, its supply and sale are regulated under the Human Medicines Regulations 2012, and use without clinical oversight falls entirely outside regulated UK healthcare

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All SAEs of death, development of signs of critical illness and severe illness requiring hospitalisation, and AEs as described previously will be reported to the Ethics Committees, the Data and Safety Monitoring Board (DSMB) and to the sponsors of the study within 24 hours of awareness of the event, followed by a final report within 10 days

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