1 “...: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness...”

2 “...: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness...”

3 “... including its natural history, biologic mechanisms of disease, and ways to measure elevated Phe to better...”

4 “... including its natural history, biologic mechanisms of disease, and ways to measure elevated Phe to better...”

5

6

7

8

9

10

11 “..., Bleeding history or predisposition, Labile international normalized ratio, Elderly [>65 years], Drugs...”

12 “..., Bleeding history or predisposition, Labile international normalized ratio, Elderly [>65 years], Drugs...”