Providing potential participants with trial information (see Participant Information Sheet) at the earliest opportunity following or during their primary therapy will allow time for them to consider their participation and for any queries or issues surrounding eligibility to be addressed. Participants should be registered for the run-in period as soon as it is considered clinically safe to do so (see diagrams showing timing of trial entry for each cohort). After the run-in period, participants should be assessed to ensure suitability for the study prior to randomisation.
There will be no exceptions to eligibility requirements at the time of registration and randomisation.
Participants will be considered eligible for enrolment if they fulfil all the inclusion criteria and none of the exclusion criteria as defined in the following sections. Eligibility should be assessed at registration and those not meeting the criteria should not join the study. After the run-in period, participants will be assessed to ensure suitability for the study prior to randomisation.
For any eligibility queries, please contact the Trial Managers at the MRC CTU (firstname.lastname@example.org) prior to attempting to register or randomise the participant.
Please select relevant cohort for detailed eligibility criteria