Cost analysis
Information will be gathered and reported on the costs incurred by patients in each arm along the treatment pathway that they follow from randomization to the end of the trial follow-up (1 year). These pathway costs will include appointments at the hospital (inpatient and outpatient), plus any primary or community care appointments, medications, and emergency attention, and any other things that might be of interest to the intended decision-maker, as well as the costs of the initial interventions themselves. The cost of the initial interventions will be determined using the previously described direct cost calculation method [