On this, there is a supporting ability to make regulations related to what will be at the legislative level to compel registration of clinical trials. It's the prescribed information in the prescribed time and manner. That would cover all of this.
Your point about observational studies, I think is a very interesting one. That's not yet well defined. It's not as well defined as pre-market studies, so you have the three well-known phases. There are very many different ways to do those.
The value of having the flexibility in the regulations is that as new types of studies come up—and they have in the rare disease area, where we're seeing more study varieties—then we can keep up with that kind of language. The ultimate flexibility is in the regulation-making that's associated with the basic commitment to register trial information.