Overview
Participants are being asked to participate in SELECT-LIFE study because participants take part in the SELECT trial.
SELECT-LIFE study is a survey-based study that will start when the SELECT trial ends.
SELECT-LIFE looks at the long-term effects of participants taking part in the SELECT trial including the trial medicine participants have been taking.
When the SELECT trial ends, participants will no longer get the medicine participants got in the study, even if participants decide to take part in the SELECT-LIFE study.
Participants will not get any specific treatment or medicine as part of the SELECT-LIFE study, and participants will be treated as participants normally would by their own doctor.
The SELECT-LIFE study will last for up to 10 years after SELECT trial ends, and participants will be asked to fill in a questionnaire about their health every 6 months.
Eligibility
Inclusion Criteria:
- Randomized into the SELECT clinical trial (EX9536-4388) and has not withdrawn consent, regardless of level of participation, dose achieved or treatment discontinuation.
- Signed SELECT-LIFE consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
Exclusion criteria:
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation