Table 2:

Risk-of-bias assessment of randomized controlled trials (RCTs) of varenicline included in the analysis of serious adverse cardiovascular events^*

Study	Adequate sequence generation	Adequate allocation concealment	Adequate blinding of personnel and participants	Adequate reporting of withdrawals and loss to follow-up	Adequate reporting of serious adverse events
Double-blind RCTs
Protocol A305108016	Unclear	Unclear	Yes	Yes	Yes
Protocol A305109517	Unclear	Unclear	Yes	Yes	Yes
Fagerstrom et al.18	Yes	Yes	Yes	Yes	Yes
Gonzales et al.19	Yes	Yes	Yes	Yes	Yes
Jorenby et al.20	Yes	Yes	Yes	Yes	Yes
Nakamura et al.21	Yes	Yes	Yes	Yes	Yes
Niaura et al.22	Yes	Yes	Yes	Yes	Yes
Nides et al.23	Yes	Yes	Yes	Yes	Yes
Oncken et al.24	Unclear	Unclear	Yes	Yes	Yes
Rigotti et al.9	Yes	Yes	Yes	Yes	Yes
Tashkin et al.25	Unclear	Unclear	Yes	Yes	Yes
Tonstad et al.26	Yes	Yes	Yes	Yes	Yes
Tsai et al.27	Yes	Yes	Yes	Yes	Yes
Williams et al.28	Unclear	Unclear	Yes	Yes	Yes
Open-label RCT
Aubin et al.29	Yes	Unclear	Yes	Yes	Yes

^*Details of the methodology of the studies are available in Appendix 3 (www.cmaj.ca/lookup/suppl/doi:10.1503/cmaj.110218/-/DC1).