This study was designed to mimic a “real-life” situation as much as possible. Although this reasoning was noteworthy, it limited the investigation results. Limitations to this study include the facts that all study sites were within the USA and that study subjects were all volunteers and may not be representative of minority smokers in the general global population. In addition, no data were collected regarding the frequency and patterns of medication use. Whereas all subjects were instructed on the proper use and dosing of all study medication, no tracking of their actual use was conducted, nor was their acceptability of the medication assigned to them or their comprehension of the instructions documented. In addition, no follow-up or data capture took place concerning any additional medications or behavioral counseling the subject may have used outside the study.
