Why tadalafil rather than another comparator?

Tadalafil was chosen as a control product at the original suggestion of FDA. We agreed with the choice as it represents a widely used marketed product in the USA. After discussion with FDA, they agreed that we could use the lowest effective and approved dose in the USA (5mg). As indicated above, the purpose of including and assessing relative efficacy and safety is to help FDA determine the benefit risk ratio for MED3000 against a marketed control. It is not a pre-requisite for success in the study that we match the efficacy of tadalafil.