Methods/design Study design This clinical trial will use a double-blind, placebo-controlled, dose escalation design, with random assignment of participants to an experimental (group A) and a control condition (group B) for 10 weeks after failure to achieve abstinence during an open-label run-in period of approximately 2 weeks using a 21-mg nicotine patch daily
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Co-existing Medical Conditions Smokers with pre-existing medical conditions, such as heart disease, high blood pressure, and diabetes, are at an even higher risk of developing ED
Outcomes of the Rasch Measurement Theory (RMT) analyses against the acceptability criteria outlined in Supplementary Table S3 are summarized in Table 3
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