Linear mixed models were used for analyzing the amount of ST use at different time points adjusting for the background level reported at the orientation visit, for each treatment group. For all analyses, p values of .05 or less were considered statistically significant. Results Subject Characteristics There were 332 subjects who were randomized at the phone screening Dorsomorphin IC50 (163 in the immediate cessation group and 169 in the reduction group). Of the 332 subjects, 206 subjects attended an orientation meeting with 101 in the immediate cessation and 105 in the reduction group, indicating that one approach was not favored over another (OR = 1.01, p = .98). Of the 206 enrolled, 7 were found to be ineligible, leading to a total of 199 subjects who continued with the study (97 in the immediate cessation group and 102 in the ST reduction group).

Among the randomized subjects, 99.7% were male, the M �� SD age was 34.8 �� 8.5, the number of tins per week was 3.6 �� 2.4, and the duration of the use of at least 6 dips per day was 11.8 �� 8.2 years. Almost all subjects used one brand of ST, but the brands varied from subject to subject. The most popular brands, which together were used by 81% of subjects at baseline, were Grizzly, Copenhagen, Skoal, and Kodiak. Subjects who entered treatment compared with those who chose not to enter treatment after randomization were significantly older (35.9 �� 9.0 vs. 33.2 �� 7.5, p = .005), but no other demographic and ST use history were significantly different. Among those who entered treatment, no significant differences were observed between the groups.

Subject Dispositions A substantial dropout rate was observed (see Figure 1). Among the 199 subjects who were eligible and attended orientation, no significant differences were observed in retention rates for immediate cessation and ST reduction groups at Week 2 (76% vs. 72%, respectively), Week 4 (61% vs. 61%, respectively), and at Week 6 (46% vs. 47%, respectively). Product Use and ST Use During Treatment Among subjects assigned to the immediate cessation group, three were unable to tolerate the patch and switched to nicotine lozenge and two subjects were reduced to the 14 mg patch. During the 2-week medication assignment, 77.3% reported use of NRT (40.2% for all 14 days). Analysis of ST reduction across all subjects in the immediate cessation group revealed significant reductions for ST use from Week 0 to Week 2 of ~7 dips per day and ~3 tins per week (p < .

0001), whereas the reduction from Week 2 to Week 6 was not statistically significant (see Table 1). Table 1. M (SD) Product Use Among subjects assigned to the ST reduction group, 14 subjects used Skoal products at baseline and were assigned to the nicotine lozenge, 24 chose brand switching, 53 chose nicotine lozenge for ST reduction, and 11 were assigned reduction Dacomitinib but dropped before choosing a reduction method.