Fig. 1

Patient composition. Pbo, placebo; rand, randomized; Pt, patient; WD, withdrew; inv, investigator decision; LFTU, lost to follow-up; AE, adverse event; prot dev, protocol deviation.

Patient composition. Pbo, placebo; rand, randomized; Pt, patient; WD, withdrew; inv, investigator decision; LFTU, lost to follow-up; AE, adverse event; prot dev, protocol deviation.