Blinding and statistical methods
REGRESSION
The study data were extracted from the centralised database and grouped, ensuring that the researchers responsible for statistical analysis were blinded to study group assignments.The analysis was based on the intention-to-treat principle (including all participants randomly assigned in V0, regardless of whether they received the allocated intervention and subsequent withdrawal or deviation from the protocol), assuming a ‘worst-case’ strategy regarding smoking (participants who did not have laboratory-confirmed abstinence data at the end of the study were considered as active smokers) [Initially, a bivariate analysis was conducted to assess the comparability and homogeneity of the groups at baseline. The prevalence of prolonged and punctual abstinence after 12 months of the intervention in both groups was compared using the Chi-Square test. Additionally, multivariate logistic regression and Cox regression analyses were performed to identify the independent risk factors associated with abstinence. The results were expressed as Odds Ratios (All measures were expressed with their respective 95% confidence interval (