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| Rows 1-20: | Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in PTTSTCND which is E-Liquid Standard (Long Term) Condition. | | Rows 2, 12, 13: | Show the Nicotine, 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK), and N-nitrosonornicotine analytes in the Aerosol substance represented using the PTSPEC variable. | | Rows 17, 18: | Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTCAT variable. The E-Liquid substance has the condition represented using the PTTSTCND which is E-Liquid Standard (Long Term) Condition. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | STOCONDID | PTSEQ | PTREFID | PTCAS | PTTESTCD | PTTEST | PTCAT | PTSCATPTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTMATRIX | PTSPCCND | PTMETHOD | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
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| 1 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | | VAP77777.1 | 54-11-5 | NIC | Nicotine | STABILITY STUDY |
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| E-Liquid Standard (Long Term) ConditionE-LIQUID |
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| 1 | Week 0 | 1 | | 2 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 2 | VAP77777.1 | 54-11-5 | NIC | Nicotine | STABILITY STUDY | E-Liquid Standard (Long Term) Condition |
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| AEROSOL |
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| 1 | Week 0 | 1 | | 3 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 3 | VAP77777.1 | 494-97-3 | XXXXX | | STABILITY STUDY | Nicotine Degradant |
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| E-Liquid Standard (Long Term) Condition | E-LIQUID | 1 | LIQUID |
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| 1 | Week 0 | 1 | | 4 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 4 | VAP77777.1 | 494-52-0 | XXXXX | | STABILITY STUDY | Nicotine Degradant |
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| E-Liquid Standard (Long Term) ConditionE-LIQUID |
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| 1 | Week 0 | 1 | | 5 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 5 | VAP77777.1 | 56-81-5 | XXXXX | Glycerin | STABILITY STUDY | Primary IngredientE-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | | 6 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 6 | VAP77777.1 | 57-55-6 | XXXXX | Propylene Glycol | STABILITY STUDY | Primary Ingredient |
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| E-Liquid Standard (Long Term) ConditionE-LIQUID |
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| 1 | Week 0 | 1 | | 7 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 7 | VAP77777.1 | 65-85-0 | XXXXX | Benzoic Acid | STABILITY STUDY | Acid |
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| E-Liquid Standard (Long Term) ConditionE-LIQUID |
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| 1 | Week 0 | 1 | | 8 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 8 | VAP77777.1 | 89-78-1
confirm this one, there are two - the other is 1490-04-6 | XXXXX | Menthol | STABILITY STUDY | FlavorantE-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | | 9 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 9 | VAP77777.1 |
| XXXXX | Vanillin | STABILITY STUDY | Flavorant |
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| E-Liquid Standard (Long Term) ConditionE-LIQUIDLIQUID |
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| 1 | Week 0 | 1 | | 10 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 10 | VAP77777.1 | 64091-91-4 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | HPHC |
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| E-Liquid Standard (Long Term) ConditionE-LIQUID |
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| 1 | Week 0 | 1 | | 11 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 11 | VAP77777.1 | 80508-23-2 | NNN | N-nitrosonornicotine | STABILITY STUDY | HPHCE-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | | 12 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 12 | VAP77777.1 | 64091-91-4 | NNK | 4-(N-methyl-N-nitrosoamino)-1-(3-pyridyl)-1-butanone (NNK) | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition |
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| AEROSOL |
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| 1 | Week 0 | 1 | | 13 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 13 | VAP77777.1 | 80508-23-2 | NNN | N-nitrosonornicotine | STABILITY STUDY | HPHC | E-Liquid Standard (Long Term) Condition |
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| AEROSOL |
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| 1 | Week 0 | 1 | | 14 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 14 | VAP77777.1 |
| XXXXX | Metals - Nickel | STABILITY STUDY | Extractables / Leachables E-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | | 15 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 15 | VAP77777.1 |
| PH | pH | STABILITY STUDY |
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| E-Liquid Standard (Long Term) ConditionE-LIQUIDLIQUID |
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| 1 | Week 0 | 1 | | 16 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 16 | VAP77777.1 |
| XXXXX | Endotoxin | STABILITY STUDY | ToxinsE-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | | 17 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 17 | VAP77777.1 |
| XXXXX | TAMC | STABILITY STUDY | Microbiological |
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| E-Liquid Standard (Long Term) ConditionE-LIQUID |
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| 1 | Week 0 | 1 | | 18 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 18 | VAP77777.1 |
| XXXXX | TYMC | STABILITY STUDY | Microbiological |
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| E-Liquid Standard (Long Term) ConditionE-LIQUID |
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| 1 | Week 0 | 1 | | 19 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 19 | VAP77777.1 | 75-07-0 | XXXXX | Acetaldehyde | STABILITY STUDY | Aldehyde | STUDY | AldehydeE-Liquid Standard (Long Term) Condition |
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| E-LIQUID |
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| 1 | Week 0 | 1 | | 20 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 20 | VAP77777.1 |
| XXXXX | Acetyl propionyl | STABILITY STUDY | Diketone |
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| E-Liquid Standard (Long Term) ConditionE-LIQUID |
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| 1 | Week 0 | 1 |
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A Shelf Life study dataset would shows analytes done in different test conditions with replicates over time points. In the interest of brevity for this example, only portions of the content using the TEST of Nicotine is shown in a sample of timepoints in two conditions with replicates. The weeks reflective of Week 1, Week 2, Week 3, etc. which would align with the PTTPTNUM of 2,3, etc. are not shown for visual viewing purposes. This is an example, this provides possible tests that might be used to demonstrate how to use the datasets and variables to show what was done for the shelf-life stability study. It shows what timepoint and what type of data follows. It is important to show different test conditions for each analyte. For aerosol a machine similutaion is use so mg/puff is valid.
| Dataset wrap |
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| Rows 1-9: | Show the PTTEST of Nicotine for E-Liquid Standard (Long Term) Condition which is shown in PTTSTCND. The sample of various timepoints that may be used in the testing for Nicotine is reflected in PTTPT. The PTTPTNUM shows the numerical version of the planned timepoint. The REPNUM shows the incidence number of a test that is repeated within a given timeframe for the same test. | | Rows 10-19: | Show the PTTEST of Nicotine for E-Vapor Standard Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. | | Rows 20-27: | Show the PTTEST of Nicotine for E-Vapor Intense Aerosol Condition across the same timepoints. The PTGRPID is used to tie together a block of related records in a single domain. |
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| Dataset2 |
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| Row | | DOMAIN | SPTOBID | STOCONID | PTSEQ | PTREFID | PTGRPID | PTTESTCD | PTTEST | PTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM |
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| 1 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 211 | VAP77777.1 | 1 | NIC | E-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 1 | Week 0 | 1 | | 2 | TOB07 | PT111 | 111 | E-Liquid Standard (Long Term) Condition | 212 | VAP77777.1 | 1 | | NicotineE-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 2 | Week 0 | 1 | | 3 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 213 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 3 | Week 0 | 1 | | 4 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 214 | VAP77777.1 | 1 | NIC | NicotineE-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 1 | Week 24 | 4 | | 5 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 215 | VAP77777.1 | 1 | NIC | NicotineE-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 2 | Week 24 | 4 | | 6 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 216 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 3 | Week 24 | 4 | | 7 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 217 | VAP77777.1 | 1 | NIC | NicotineE-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 1 | Week 52 | 9 | | 8 | TOB07 | PT111 | 111 | E-Liquid Standard (Long Term) Condition | 218 | VAP77777.1 | 1 | NIC | NicotineE-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 2 | Week 52 | 9 | | 9 | TOB07 | PT | 111 | E-Liquid Standard (Long Term) Condition | 219 | VAP77777.1 | 1 | NIC | Nicotine | E-Liquid Standard (Long Term) Condition |
| mg/mL |
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| mg/mL | E-LIQUID |
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| 3 | Week 52 | 9 | | 10 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 220 | VAP77777.1 | 3 | NIC | E-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 1 | Week 0 | 1 | | 11 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 221 | VAP77777.1 | 3 | NIC | Nicotine | NIC | NicotineE-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 2 | Week 0 | 1 | | 12 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 222 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 3 | Week 0 | 1 | | 13 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 223 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 1 | Week 24 | 4 | | 14 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 224 | VAP77777.1 | 3 | NIC | NicotineE-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 2 | Week 24 | 4 | | 15 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 225 | VAP77777.1 | 3 | NIC | Nicotine | | NicotineE-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 3 | Week 24 | 4 | | 16 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 226 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 1 | Week 52 | 9 | | 17 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 227 | VAP77777.1 | 3 | NIC | Nicotine | E-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 2 | Week 52 | 9 | | 18 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 228 | VAP77777.1 | 3 | NIC | NicotineE-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 3 | Week 52 | 9 | | 19 | TOB07 | PT | 111 | E-Vapor Standard Aerosol Condition | 229 | VAP77777.1 | 3 | NIC | Nicotine | NIC | NicotineE-Vapor Standard Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 1 | Week 0 | 1 | | 20 | TOB07 | PT | 111 | E-Vapor Intense Aerosol Condition | 230 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 2 | Week 0 | 1 | | 21 | TOB07 | PT |
| E-Vapor Intense Aerosol Condition | 231 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 3 | Week 0 | 1 | | 22 | TOB07 | PT |
| E-Vapor Intense Aerosol Condition | 232 | VAP77777.1 | 4 | NIC | NicotineE-Vapor Intense Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 1 | Week 24 | 4 | | 23 | TOB07 | PT |
| E-Vapor Intense Aerosol Condition | 233 | VAP77777.1 | 4 | NIC | Nicotine | | NicotineE-Vapor Intense Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 2 | Week 24 | 4 | | 24 | TOB07 | PT |
| E-Vapor Intense Aerosol Condition | 234 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 3 | Week 24 | 4 | | 25 | TOB07 | PT |
| E-Vapor Intense Aerosol Condition | 235 | VAP77777.1 | 4 | NIC | Nicotine | E-Vapor Intense Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 1 | Week 52 | 9 | | 26 | TOB07 | PT |
| E-Vapor Intense Aerosol Condition | 236 | VAP77777.1 | 4 | NIC | NicotineE-Vapor Intense Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 2 | Week 52 | 9 | | 27 | TOB07 | PT |
| E-Vapor Intense Aerosol Condition | 237 | VAP77777.1 | 4 | NIC | NicotineE-Vapor Intense Aerosol Condition |
| mg/puff |
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| mg/puff | AEROSOL |
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| 3 | Week 52 | 9 |
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