Just to address the implantation registry, it's something that we did consider in the review. Specifically, the panel recommended that Health Canada consult with the Canadian Institute for Health Information on the subject of a registry. We did that. We actually went back to CIHI because they're the national experts in terms of data collection and database and registries, and they went through all the information that we have with breast implants. Their opinion--and we actually have that in writing--would be that a national registry would not be the best way to follow these patients.
There were a number of different reasons that they actually signified that it wasn't. One was that for a registry you actually a priori usually identify the events that you're looking for, and that for a registry to work we would have to mandate reporting. As an interesting point, the U.K. breast implant registry was operable for a number of years. They closed it down for two reasons. One was that they didn't actually get a very high level of participation, and the second was that they didn't actually get any meaningful clinical data out of the registry.
So we did consult with CIHI on the issue, and they went through all of the reasons why it wouldn't be the best way to monitor the patients, which is why then we began to think of what would be the best way to monitor these patients. What conditions could we put on? The way we structured the clinical trials not only met the outcomes of what people were looking for in a registry, but it surpassed them.