Direct-participant mail-based follow-up and adjudication
Bleeding, bleeding, ’
BLEEDING, BLEEDING, RECRUITMENT, BLIND
The principal method of direct-participant recruitment and follow-up was by mailed or online questionnaire 6-monthly. On questionnaires, participants were asked to indicate if they had suffered ‘Bleeding for which you saw a doctor’ and to record a date and the site of the bleeding. Participants were also asked ‘Were you admitted to hospital?’ Study clinicians blind to treatment allocation coded the bleeding site using the free-text information, and these data are referred to in this manuscript as ‘pre-adjudicated direct-participant follow-up’ (
