St u d y desi g n a n d patie nt n u m bers u p date d t o reflect c o h orts re m o ve d a n d re vise d patie nt n u m bers i n pr ot oc ol versi o n 5. Secti o n 3. 1 u p date d t o reflect ne w t u m o ur assess me nt sc he d ule a n d t o re m o ve refere nces t o c o h orts re m o ve d i n pr ot oc ol versi o n 5. Secti o n 3. 3 re m o ve d refere nces t o E C G i nter val data as t his is n ot bei n g c ollecte d. Secti o n 3.