All participants who give consent for participation and who fulfil the inclusion criteria will be randomised. Randomisation will be performed centrally by the study manager using an online bespoke randomisation module provided and managed by Norwich Clinical Trials Unit (NCTU). The allocation sequence will be generated by the NCTU applying a permuted block design with random blocks stratified by study centre. The randomisation list remains with NCTU for the whole duration of the study. Thus, randomisation will be conducted without any influence of the principal investigators, MHSWs, or REPs.

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