While the definition of beyond reasonable doubt will be left to the judgement of the Safety and Data Monitoring Committee, other committees have considered that a difference in total mortality between randomised groups of three standard deviations would normally constitute such evidence. While a major focus of the Committee's brief will be to monitor total mortality, they would also be provided data on serious adverse events and would not be precluded from making recommendations based on other outcomes such as cause-specific death or serious non-fatal adverse events.