If the individual components of the composites meet all relevant code requirements and guidelines (e.g. pre-defined statistical analysis for individual components, directionally consistent with overall, within the limitations of the indication) then individual components of a composite can be presented. Note that they should be presented in the context of the overall composite endpoint. Caution: There are many potential reasons why all relevant code requirements might not be met. For example, last week I saw an example in which the TMA study was not blinded and the endpoints were subjective. We therefore had to limit the APS presentation to the content found in the TMA.