What happens at other appointments?

Your next two appointments (called follow-up visits) will be about one month and three months after your second study visit Your randomisation visit).

The blood tests taken for these first two follow-up visits will include a check of the levels of stress hormone cortisol in your blood. It is important, wherever possible, that the blood tests for these two visits are taken early in the morning (ideally before 09:00) to ensure the results of a cortisol test can be reliably interpreted. taking samples after 09:00 might mean they need to be repeated and we want to avoid this inconvenience for you wherever possible. We appreciate your cooperation with timing of appointments.

 You will not be given any study pills at the one month follow-up visit. At the three month follow-up visit you will be given another supply of study pills and the study research team will see you three months later and then every six months. Blood sampling will usually not be required to be before 09:00 at subsequent visits.

Note that only at the one month and three-month visits will you need to have early morning (ideally before 09:00) blood tests. However, your contribution to the study could be even more valuable if you would be willing to have early morning blood tests at every study visit. This would allow us to learn about any changes in hormone levels caused by study pills over a longer period of time but is an optional part of the study.

At each six-monthly follow-up visit, the study team will ask you about any new medical problems since your last appointment, give you the next supply of study pills, and take a blood sample (between three to six teaspoons each time), and possibly a urine sample. Each follow-up visit is designed to ideally take less than 30 minutes (although the time needed to collect blood samples and dispense study pills can vary from hospital to hospital).

Following your last trial follow-up visit, you will stop the study pills.