Mean percentage change in body weight and mean changes in vital signs from week –14 (screening) to week 68 (follow-up). Data for body weight (a) are observed means±s.e. for individuals completing each scheduled visit. Data for SBP (b) and DBP (c) are for the full analysis set (n=413), and for pulse (d) are for the safety set (n=422) and are observed means. Values at week 0 (randomization) were arbitrarily set to 0. S, screening period; F, follow-up.