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Note |
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- The use of SPDEVID and PTREFID in this example on records where PTSPEC=AEROSOL indicates that a smoking machine (shown in SPDEVID) was used to perform the vaping regimen (shown in PTREFID) to produce the aerosol from the e-liquid product on records where PTSPEC=AEROSOL. Details of the smoking machine and vaping regimen are not shown in this example. For examples illustrating how to represent these concepts in SDTM, see Section 3.1.3.2, HPHCs, Other Constituents, and Smoking / Vaping Regimens.
- PTXFN (External File Path) is used to document the location or file name within the submission that contains the lab methodology protocol used to assay the associated constituent when such methodology is too complex for the single PTMETHOD variable.
- STOCONID is used to identify the storage conditions of the e-liquid product for the testing performed. Details of these conditions are represented in the ES dataset example that follows the two PT dataset examples.
- In this example, the applicant chose to sub-categorize some consituents and parameters using the permissible variable PTSCAT (Sub-Category of Test).
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Dataset wrap |
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Rowcaps |
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Rows 1, 3, 5, 7, 9, 10, 15, 17-19, 22, 24, 25, 27-31: | Show the results of testing for constituents in samples of e-liquid product (PTSPEC=E-LIQUID). | Rows 2, 4, 6, 8, 11-14, 16, 20, 21, 23, 26: | Show the results of testing for constituents/parameters in aerosol produced from the e-liquid product. The smoking machine is shown in SPDEVID and the regimen is shown in PTREFID. |
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | STOCONDID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU | PTNAM | PTXFN | PTSPEC | PTLLOQ | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | 111 |
| Condition 1 | | | NICOTINE | Nicotine | STABILITY STUDY |
| 35.94 | mg/g |
| 35.94 | 35.94 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 2 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 2 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | STABILITY STUDY |
| | mg/PUFF |
| 0.1039 | 0.1039 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 3 | TOB07 | PT | 111 |
| Condition 1 | 3 |
| NORNCTN | | STABILITY STUDY | Nicotine Degradant | 25.76 | ug/g |
| 25.76 | 25.76 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 4 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 4 | NON-INTENSE REGIMEN | NORNCTN | | STABILITY STUDY | Nicotine Degradant | 0.0392 | ug/PUFF |
| 0.0392 | 0.0392 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 5 | TOB07 | PT | 111 |
| Condition 1 | 5 |
| GLYCRL | Glycerol | STABILITY STUDY | Primary Ingredient | 615.68 | mg/g |
| 615.68 | 615.68 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 6 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 6 | NON-INTENSE REGIMEN | GLYCRL | Glycerol | STABILITY STUDY | Primary Ingredient | 1.81 | mg/PUFF | 0.00144 | 1.81 | 1.81 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 7 | TOB07 | PT | 111 |
| Condition 1 | 7 |
| PRPYLGLY | Propylene Glycol | STABILITY STUDY | Primary Ingredient | 218.21 | mg/g |
| 218.21 | 218.21 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 8 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 8 | NON-INTENSE REGIMEN | PRPYLGLY | Propylene Glycol | STABILITY STUDY | Primary Ingredient | 0.8565 | mg/PUFF | 0.00024 | 0.8565 | 0.8565 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 9 | TOB07 | PT | 111 |
| Condition 1 | 9 |
| BNZOICAC | Benzoic Acid | STABILITY STUDY | Acid | 42.2 | ug/PUFF |
| 42.2 | 42.2 | ug/PUFF | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 10 | TOB07 | PT | 111 |
| Condition 1 | 10 |
| MENTHOL | Menthol | STABILITY STUDY | Flavorant | 37.53 | mg/g |
| 37.53 | 37.53 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 11 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 11 | NON-INTENSE REGIMEN | MENTHOL | Menthol | STABILITY STUDY | Flavorant | 0.5881 | mg/PUFF | 0.00024 | 0.5881 | 0.5881 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 12 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 12 | NON-INTENSE REGIMEN | GLYCDOL | Glycidol | STABILITY STUDY | Stabilizer | NOT DETECTED |
| 0.00011 | NOT DETECTED |
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| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 13 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 13 | NON-INTENSE REGIMEN | FRMLDHD | Formaldehyde | STABILITY STUDY |
| 0.0728 | ug/PUFF | 0.00549 | 0.0728 | 0.0728 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 14 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 14 | NON-INTENSE REGIMEN | ACROLN | Acrolien | STABILITY STUDY |
| DETECTED, BELOW LLOQ |
| 0.00928 | DETECTED, BELOW LLOQ |
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| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 15 | TOB07 | PT | 111 |
| Condition 1 | 15 |
| LACTICAC | Lactic Acid | STABILITY STUDY |
| 40.44 | ug/g |
| 40.44 | 40.44 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 16 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 16 | NON-INTENSE REGIMEN | LACTICAC | Lactic Acid | STABILITY STUDY |
| 29.71 | ug/PUFF | 0.284 | 29.71 | 29.71 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 17 | TOB07 | PT | 111 |
| Condition 1 | 17 |
| VANLLN | Vanillin | STABILITY STUDY | Flavorant | 1.12 | ug/g |
| 1.12 | 1.12 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 18 | TOB07 | PT | 111 |
| Condition 1 | 18 |
| NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY STUDY | HPHC | 0.0711 | ug/g |
| 0.0711 | 0.0711 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 19 | TOB07 | PT | 111 |
| Condition 1 | 19 |
| NNN | N-Nitrosonornicotine | STABILITY STUDY | HPHC | 0.0852 | ug/g |
| 0.0852 | 0.0852 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 20 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 20 | NON-INTENSE REGIMEN | NNK | Nicotine-Derived Nitrosamine Ketone | STABILITY STUDY | HPHC | 0.0577 | ug/PUFF |
| 0.0577 | 0.0577 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 21 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 21 | NON-INTENSE REGIMEN | NNN | N-Nitrosonornicotine | STABILITY STUDY | HPHC | 0.0742 | ug/PUFF |
| 0.0742 | 0.0742 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 22 | TOB07 | PT | 111 |
| Condition 1 | 22 |
| NICKEL | Nickel | STABILITY STUDY | Extractables / Leachables | 0.0897 | ug/g |
| 0.0897 | 0.0897 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 23 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 23 | NON-INTENSE REGIMEN | MASS | Mass | STABILITY STUDY |
| 3.87 | mg/PUFF | 0.0071 | 3.87 | 3.87 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 24 | TOB07 | PT | 111 |
| Condition 1 | 24 |
| CHROMIUM | Chromium | STABILITY STUDY |
| NOT DETECTED |
|
| NOT DETECTED |
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| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 25 | TOB07 | PT | 111 |
| Condition 1 | 25 |
| PH | pHpH Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-109 |
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| STABILITY STUDY |
| 7.15 |
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| 7.15 | 7.15 |
| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 26 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 1 | 26 | NON-INTENSE REGIMEN | PH | pH | STABILITY STUDY |
| 7.24 |
|
| 7.24 | 7.24 |
| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 27 | TOB07 | PT | 111 |
| Condition 1 | 27 |
| ENDTXN | Endotoxin | STABILITY STUDY | Toxins | NOT DETECTED |
|
| NOT DETECTED |
|
| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 28 | TOB07 | PT | 111 |
| Condition 1 | 28 |
| AEBPLCT | Aerobic Plate Count | STABILITY STUDY | Microbiological | <1 | CFU/mL |
| <1 |
| CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 29 | TOB07 | PT | 111 |
| Condition 1 | 29 |
| TYMC | Total Yeast and/or Mold Count | STABILITY STUDY | Microbiological | 1 | CFU/mL |
| 1 | 1 | CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 30 | TOB07 | PT | 111 |
| Condition 1 | 30 |
| ACTALD | Acetaldehyde | STABILITY STUDY | Aldehyde | 7.8 | ug/mL |
| 7.8 | 7.8 | ug/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 | 31 | TOB07 | PT | 111 |
| Condition 1 | 31 |
| ACTPROPN | Acetyl Propionyl | STABILITY STUDY | Diketone | 32.4 | ug/mL |
| 32.4 | 32.4 | ug/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 0.001 | 1 | 02-01-2023 | Week 0 | 1 |
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Dataset wrap |
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Dataset2 |
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Row | | DOMAIN | SPTOBID | SPDEVID | STOCONID | PTSEQ | PTREFID | PTTESTCD | PTTEST | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTNAM | PTXFN | PTSPEC | PTREPNUM | PTDTC | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | 111 |
| Condition 1 | 211 |
| NICOTINE | | 35.94 | mg/g | 35.94 | 35.94 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 02-01-2023 | Week 0 | 1 | 2 | TOB07 | PT | 111 |
| Condition 1 | 212 | | | Nicotine | 35.46 | mg/g | 35.46 | 35.46 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 02-01-2023 | Week 0 | 1 | 3 | TOB07 | PT | 111 |
| Condition 1 | 213 |
| NICOTINE | Nicotine | 35.97 | mg/g | 35.97 | 35.97 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 02-01-2023 | Week 0 | 1 | 4 | TOB07 | PT | 111 |
| Condition 1 | 214 |
| NICOTINE | Nicotine | 35.55 | mg/g | 35.55 | 35.55 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 03-29-2023 | Week 8 | 2 | 5 | TOB07 | PT | 111 |
| Condition 1 | 215 |
| NICOTINE | Nicotine | 35.88 | mg/g | 35.88 | 35.88 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 03-29-2023 | Week 8 | 2 | 6 | TOB07 | PT | 111 |
| Condition 1 | 216 |
| NICOTINE | Nicotine | 35.67 | mg/g | 35.67 | 35.67 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 03-29-2023 | Week 8 | 2 | 7 | TOB07 | PT | 111 |
| Condition 1 | 217 |
| NICOTINE | Nicotine | 36.11 | mg/g | 36.11 | 36.11 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | 07-19-2023 | Week 24 | 3 | 8 | TOB07 | PT | 111 |
| Condition 1 | 218 |
| NICOTINE | Nicotine | 35.72 | mg/g | 35.72 | 35.72 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | 07-19-2023 | Week 24 | 3 | 9 | TOB07 | PT | 111 |
| Condition 1 | 219 |
| NICOTINE | Nicotine | 35.54 | mg/g | 35.54 | 35.54 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | 07-19-2023 | Week 24 | 3 | 10 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 220 | NON-INTENSE REGIMEN | NICOTINE | | 0.1039 | mg/PUFF | 0.1039 | 0.1039 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 02-01-2023 | Week 0 | 1 | 11 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 221 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1142 | mg/PUFF | 0.1142 | 0.1142 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 02-01-2023 | Week 0 | 1 | 12 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 222 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1282 | mg/PUFF | 0.1282 | 0.1282 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 02-01-2023 | Week Week 0 | 1 | 13 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 223 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1242 | mg/PUFF | 0.1242 | 0.1242 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 03-29-2023 | Week 8 | 2 | 14 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 224 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1084 | mg/PUFF | 0.1084 | 0.1084 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 03-29-2023 | Week 8 | 2 | 15 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 225 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1174 | mg/PUFF | 0.1174 | 0.1174 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 03-29-2023 | Week 8 | 2 | 16 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 226 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1374 | mg/PUFF | 0.1374 | 0.1374 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 07-19-2023 | Week 24 | 3 | 17 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 227 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1364 | mg/PUFF | 0.1364 | 0.1364 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 07-19-2023 | Week 24 | 3 | 18 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 228 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1264 | mg/PUFF | 0.1264 | 0.1264 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 07-19-2023 | Week 24 | 3 | 19 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 2 | 229 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1256 | mg/PUFF | 0.1256 | 0.1256 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 02-01-2023 | Week 0 | 1 | 20 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 230 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1236 | mg/PUFF | 0.1236 | 0.1236 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 02-01-2023 | Week 0 | 1 | 21 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 231 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1126 | mg/PUFF | 0.1126 | 0.1126 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 02-01-2023 | Week 0 | 1 | 22 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 232 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1334 | mg/PUFF | 0.1334 | 0.1334 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 03-29-2023 | Week 8 | 2 | 23 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 233 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1134 | mg/PUFF | 0.1134 | 0.1134 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 03-29-2023 | Week 8 | 2 | 24 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 234 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1125 | mg/PUFF | 0.1125 | 0.1125 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 03-29-2023 | Week 8 | 2 | 25 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 235 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1156 | mg/PUFF | 0.1156 | 0.1156 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | 07-19-2023 | Week 24 | 3 | 26 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 236 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1145 | mg/PUFF | 0.1145 | 0.1145 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | 07-19-2023 | Week 24 | 3 | 27 | TOB07 | PT | 111 | PUFFMASTER3K | Condition 3 | 237 | NON-INTENSE REGIMEN | NICOTINE | Nicotine | 0.1157 | mg/PUFF | 0.1157 | 0.1157 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | 07-19-2023 | Week 24 | 3 |
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Details of the storage conditions are represented in the Environmental Storage Conditions (ES) dataset. The variable STOCONID/Storage Condition ID represents the storage condition and links to the PT datasets above by matching values of STOCONID there. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU. The es.xpt dataset below shows all three sets of storage conditions used across both pt.xpt dataset examples above.
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