Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\]. Subjects participating in this observational study originally participated in study A4061012 \[NCT00076011\], and may have also have participated in study A4061008 \[NCT00828919\].
5-year survival information to be updated.