| Methods |
Country: France
Recruitment: community volunteers |
| Participants |
433 smokers (excludes 25 from ITT population)
52% female, average age 39, average cpd 21 |
| Interventions |
1. Nicotine lozenge (1 mg, 8 to 24/day, 6 weeks + 6 weeks weaning for quitters)
2. Placebo lozenge
Level of support: not stated |
| Outcomes |
PP abstinence at 26 weeks
Validation: CO < 10 ppm |
| Notes |
Based on published abstract
Study was funded by Novartis Consumer Health |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Method not stated |
| Allocation concealment (selection bias) |
Unclear risk |
Method not stated |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Described as "double‐blind", but no further information |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Higher losses in placebo than active group (44% vs 37%); analyses conducted as ITT counting dropouts as treatment failures |
