Although steps will be taken to avoid it, protocol deviations may happen subject to changes based on the evolution of the COVID-19 pandemic that was occurring during the time of writing. Protocol deviations that occur after the start of trial recruitment will be documented on a Protocol Deviation form and reported to the CI and Sponsor immediately. Deviations from the protocol which are found to frequently recur are not acceptable, will require immediate action, and could potentially be classified as a serious breach. Serious breaches to the principles of Good Clinical Practice and/or the protocol will be relayed to the sponsor immediately.

Consent will be managed sensitively given the age of the young people. Participants will be provided sufficient time to read the information provided to them in the information sheet. They will be given the opportunity to ask questions they might have. If they are willing to continue, then consent/assent will be given. The parents or carers will be consented to provide study assessment about the young person in their care (this is an inclusion criteria). Young people aged 16 or older will provide written consent, and those under 16 will be asked to provide written assent to participate but will also require consent to be provided by their parent or carer. During this feasibility phase, the numbers of young people unable to join the study for this reason will be recorded. In some cases, the role of the parent may be taken by a legal carer (foster carer, or Social Services), and in these cases, relevant consent and engagement by carers (sometimes not the legal guardian) will be facilitated.

All study-related information will be stored securely at each study site. All participant information will be stored in locked file cabinets. All reports, data collection, process, and administrative forms will be identified by a coded ID number only to maintain participant confidentiality. All records that contain names or other personal identifiers will be stored separately from study records identified by a code number. All local databases will be secured with password-protected access systems. Any documents that link participant ID numbers to other identifying information will be stored in a separate, locked file.

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