The first step in assessing the acceptability of the study is to determine if it is consistent with the TMA. We would consider consistency with the indication/patient population studied, dosing, etc. As the indication specifies that the product is an add-on to drug B and it is not used in that fashion in the study, the study design does not appear to be consistent with the TMA. As this appears to be a specific question about a specific product and study, we suggest submitting the published study in an opinion file where we can assess the study design and consistency with TMA.