Multiple testing
SECONDARY
For the primary endpoint, we will use a hierarchical testing procedure. This means first we will test the non-inferiority hypothesis at a one-sided alpha of 2.5%. After non-inferiority can be demonstrated, superiority will be tested also using a one-sided alpha of 2.5%. The secondary endpoints include the components of the primary outcome and are needed to support the interpretation of the potential effects in the primary endpoint. The tests for these comparisons would require larger sample sizes to achieve the required power. This was the reason why a composite endpoint has been chosen and these analyses are considered supportive only without further multiplicity correction. For the analyses of all secondary endpoints, two-sided 