In terms of the assessment of quality of life, many of the clinical trials that are done with new drugs now include measurements of quality of life that the committee will look at, and that helps in assessment of what's called the cost per quality-adjusted life, which is a frequently used standard to assess cost-effectiveness of the drug.
We don't have an ethicist on the committee per se, and as to how to incorporate an ethical framework into the decision-making process, I may turn to Mr. Wright to address that. The mandate of our process is to look at the evidence on the clinical effectiveness and safety and the cost-effectiveness, and to make a recommendation on that basis.