Data collection
death
The study procedures and data collection methods for the main outcomes are presented in detail in the main study report [All instances of death were systematically investigated by the local study teams. After becoming aware of a possible death case, study personnel contacted relatives, peers or medical staff to confirm the death and ascertain the date and the cause of death. All case report forms were independently assessed by two independent physicians to verify and categorize the cause; discrepancies were resolved by a third physician.