5); the Peto odds ratio was 0.96 (0.75 to 1.22; P=0.74, I2=0.0%) and the risk difference was −0.001 (−0.01 to 0.01; P=0.74, I2=0.0%). Death was reported in 36 trials (total 13/5760 in the varenicline group and 11/4887 in the placebo group). The Peto odds ratio for death was 1.05 (0.47 to 2.38; P=0.9, I2=38.7%), and there was no evidence of an increased risk of death in the varenicline group compared with the placebo group (risk difference 0.0001, −0.003 to 0.003; P=0.94, I2=0.0%) (table 4). The forest plots for the secondary outcomes are shown in appendix 3.