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16.2.5 Compliance And/Or Drug Concentration Data Clinical Study Report Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 16.2.5 Compliance and/or Drug Concentration Data Clinical Study Report Confidential Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 Listing 16.2.5-1 Product Dispensation by Subject (Page 1 of 86) Study Population: ITT Subject Amount Dispensed Number Timepoint Study product (logs) R1001 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 4 1.0 g of snus or placebo logs dispensed 0 Week 10 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 4 R1002 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 Week 10 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 R1003 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Clinical Study Report Confidential Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 Listing 16.2.5-1 Product Dispensation by Subject (Page 2 of 86) Study Population: ITT Subject Amount Dispensed Number Timepoint Study product (logs) R1004 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 3 1.0 g of snus or placebo logs dispensed 3 Week 10 0.5 g of snus or placebo logs dispensed 6 1.0 g of snus or placebo logs dispensed 0 R1005 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 4 1.0 g of snus or placebo logs dispensed 2 Week 10 0.5 g of snus or placebo logs dispensed 5 1.0 g of snus or placebo logs dispensed 2 R1006 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Clinical Study Report Confidential Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 Listing 16.2.5-1 Product Dispensation by Subject (Page 3 of 86) Study Population: ITT Subject Amount Dispensed Number Timepoint Study product (logs) R1006 Week 6 0.5 g of snus or placebo logs dispensed 3 1.0 g of snus or placebo logs dispensed 0 Week 10 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 R1007 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 Week 10 0.5 g of snus or placebo logs dispensed 3 1.0 g of snus or placebo logs dispensed 0 R1008 Week 0 0.5 g of snus or placebo logs dispensed 10 1.0 g of snus or placebo logs dispensed 6 Week 6 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 Clinical Study Report Confidential Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 Listing 16.2.5-1 Product Dispensation by Subject (Page 4 of 86) Study Population: ITT Subject Amount Dispensed Number Timepoint Study product (logs) R1009 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 1 1.0 g of snus or placebo logs dispensed 0 R1010 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 2 Week 10 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 4 R1011 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 Clinical Study Report Confidential Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 Listing 16.2.5-1 Product Dispensation by Subject (Page 5 of 86) Study Population: ITT Subject Amount Dispensed Number Timepoint Study product (logs) R1011 Week 10 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 R1012 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 1 1.0 g of snus or placebo logs dispensed 3 Week 10 0.5 g of snus or placebo logs dispensed 1 1.0 g of snus or placebo logs dispensed 5 R1013 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 3 1.0 g of snus or placebo logs dispensed 0 Week 10 0.5 g of snus or placebo logs dispensed 3 1.0 g of snus or placebo logs dispensed 0 Clinical Study Report Confidential Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 Listing 16.2.5-1 Product Dispensation by Subject (Page 6 of 86) Study Population: ITT Subject Amount Dispensed Number Timepoint Study product (logs) R1014 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 R1015 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 1 1.0 g of snus or placebo logs dispensed 0 Week 10 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 R1016 Week 0 0.5 g of snus or placebo logs dispensed 10 1.0 g of snus or placebo logs dispensed 6 Week 6 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 2 Week 10 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 2 Clinical Study Report Confidential Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 Listing 16.2.5-1 Product Dispensation by Subject (Page 7 of 86) Study Population: ITT Subject Amount Dispensed Number Timepoint Study product (logs) R1017 Week 0 0.5 g of snus or placebo logs dispensed 08 1.0 g of snus or placebo logs dispensed 04 Week 6 0.5 g of snus or placebo logs dispensed 2 1.0 g of snus or placebo logs dispensed 0 Week 10 0.5 g of snus or placebo logs dispensed 1 1.0 g of snus or placebo logs dispensed 0 R1018 Week 0 0.5 g of snus or placebo logs dispensed 10 1.0 g of snus or placebo logs dispensed 06 Week 6 0.5 g of snus or placebo logs dispensed 1 1.0 g of snus or placebo logs dispensed 0 R1019 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 3 Clinical Study Report Confidential Covance CRU Study No. 7694-105 Sponsor Protocol No. SM 08-01 Listing 16.2.5-1 Product Dispensation by Subject (Page 8 of 86) Study Population: ITT Subject Amount Dispensed Number Timepoint Study product (logs) R1019 Week 10 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 3 R1020 Week 0 0.5 g of snus or placebo logs dispensed 8 1.0 g of snus or placebo logs dispensed 4 Week 6 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 2 Week 10 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 2 R1021 Week 0 0.5 g of snus or placebo logs dispensed 10 1.0 g of snus or placebo logs dispensed 6 Week 6 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 2 Week 10 0.5 g of snus or placebo logs dispensed 0 1.0 g of snus or placebo logs dispensed 3 Clinical Study Report Confidential Covance CRU Study No.
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