Statistical analyses
death, bleeding
EVENTS, BLEEDING
Analyses included only those events that occurred between randomisation and date of death or censoring, except for participants living in Northern Ireland where routine data follow-up was censored at day zero. For the major bleeding outcome (and its components), participants were categorised as having ‘outcome in both datasets’, ‘outcome in routine data only’, ‘outcome in adjudicated follow-up alone’ or ‘no such outcome in either dataset’, irrespective of the relative timings of the events. Comparisons between routine data and adjudicated direct-participant follow-up were performed using sensitivity, specificity and kappa statistics with 95% CIs.All randomised comparisons used standard log-rank methods