What happens next if I agree to be included in this study?
If you decide to join, you will be asked to sign the consent form. Next, brief details identifying you and answering a few questions about your health and medical conditions will be entered into a computer. The computer will then allocate you at random (like rolling a dice) to one of the possible treatment options. In all cases this will include the usual standard of care for your hospital. It may also include an additional treatment, which might be given by mouth, or injection. Neither you nor your doctors can choose which of these options you will be allocated. If your condition is severe or should deteriorate, then your doctors may choose to enter you into a second phase in which the computer will allocate you at random again to one of the further possible treatment options (in addition to your previous study treatment and always including usual standard of care for your hospital).
Additional information about your health will be recorded and entered into the study computer but no additional visits will be required after you leave the hospital. In some instances, information about your health (both prior to, during, and after the study) may be obtained about you from medical records or databases (including NHS Digital, Public Health England, other equivalent bodies, and genetic or other research databases if you have provided samples to them) so that the study team can get more detailed or longer term information about the effects of the study treatments on your health for up to 10 years after the end of your participation.