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| Rows 1-31: | Show several analytes (as noted in the PTTEST) in the E-Liquid substance for the condition noted in STOCONDID which is Condition 1. | | Rows 2, 4, 6, 8, 11, 12, 13, 14, 16, 20, 21, 23, 26: | Show the several analytes such as 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 28, 29: | Show microbials, TAMC and TYMC (PTTEST and PTTESTCD), used in testing (aerobic plate count, mold, and yeast) using the PTSCAT variable. |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | SPDEVID | STOCONDID | PTSEQ |
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PTREFID | | PTTESTCD | PTTEST | PTCAT | PTSCAT | PTORRES | PTORRESU | PTLLOD | PTSTRESC | PTSTRESN | PTSTRESU |
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PTSPECPTSPCCNDPTMETHOD| PTSPEC | PTLLOQ | PTREPNUM | PTTPT | PTTPTNUM |
|---|
| 1 | TOB07 | PT | 111 |
| Condition 1 | |
VAP77777.1 | | NICOTINE | Nicotine | STABILITY STUDY |
| 35.94 | mg/g |
| 35.94 | 35.94 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 2 | TOB07 | PT | 111 |
| Condition 1 | 2 |
VAP77777.1 | | NICOTINE | Nicotine | STABILITY STUDY |
| | mg/PUFF |
| 0.1039 | 0.1039 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 3 | TOB07 | PT | 111 |
| Condition 1 | 3 |
VAP77777.1 | | NORNCTN | | STABILITY STUDY | Nicotine Degradant | 25.76 | ug/g |
| 25.76 | 25.76 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 4 | TOB07 | PT | 111 |
| Condition 1 | 4 |
VAP77777.1 | NORNCTN | | STABILITY STUDY | Nicotine Degradant | 0.0392 | ug/PUFF |
| 0.0392 | 0.0392 | ug/PUFF |
AEROSOL | 1 | | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 5 | TOB07 | PT | 111 |
| Condition 1 | 5 |
VAP77777.1 | | GLYCRL | Glycerol | STABILITY STUDY | Primary Ingredient | 615.68 | mg/g |
| 615.68 | 615.68 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 6 | TOB07 | PT | 111 |
| Condition 1 | 6 |
VAP77777.1 | | 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 |
| 1 | Week 0 | 1 | | 7 | TOB07 | PT | 111 |
| Condition 1 | 7 |
VAP77777.1 | | 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 |
| 1 | Week 0 | 1 | | 8 | TOB07 | PT | 111 |
| Condition 1 | 8 |
VAP77777.1 | | 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 |
| 1 | Week 0 | 1 | | 9 | TOB07 | PT | 111 |
| Condition 1 | 9 |
VAP77777.1 | BNZOICAC | Benzoic Acid | STABILITY STUDY | Acid | 42.2 | ug/PUFF |
| 42.2 | 42.2 | ug/PUFF | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 10 | TOB07 | PT | 111 |
| Condition 1 | 10 |
VAP77777.1 | MENTHOL | Menthol | STABILITY STUDY | Flavorant | 37.53 | mg/g |
| 37.53 | 37.53 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 11 | TOB07 | PT | 111 |
| Condition 1 | 11 |
VAP77777.1 | | MENTHOL | Menthol | STABILITY STUDY | Flavorant | 0.5881 | mg/PUFF | 0.00024 | 0.5881 | 0.5881 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 12 | TOB07 | PT | 111 |
| Condition 1 | 12 |
VAP77777.1 | | GLYCDOL | Glycidol | STABILITY STUDY | Stabilizer | <Limit of Detection (LOD) |
| 0.00011 | <Limit of detection (LOD) |
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| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 13 | TOB07 | PT | 111 |
| Condition 1 | 13 |
VAP77777.1 | FRMLDHD | Formaldehyde | STABILITY STUDY |
| 0.0728 | ug/PUFF | 0.00549 | 0.0728 | 0.0728 | ug/PUFF |
AEROSOL | 1 | | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 14 | TOB07 | PT | 111 |
| Condition 1 | 14 |
VAP77777.1 | | ACROLN | Acrolien | STABILITY STUDY |
| <Limit of Quantification (LOQ) |
| 0.00928 | Limit of Quantification (LOQ) |
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| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 15 | TOB07 | PT | 111 |
| Condition 1 | 15 |
VAP77777.1 | | LACTICAC | Lactic Acid | STABILITY STUDY |
| 40.44 | ug/g |
| 40.44 | 40.44 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 16 | TOB07 | PT | 111 |
| Condition 1 | 16 |
VAP77777.1 | | LACTICAC | Lactic Acid | STABILITY STUDY |
| 29.71 | ug/PUFF | 0.284 | 29.71 | 29.71 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 17 | TOB07 | PT | 111 |
| Condition 1 | 17 |
VAP77777.1 | | VANLLN | Vanillin | STABILITY STUDY | Flavorant | 1.12 | ug/g |
| 1.12 | 1.12 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 18 | TOB07 | PT | 111 |
| Condition 1 | 18 |
VAP77777.1NNK | | 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 |
| 1 | Week 0 | 1 | | 19 | TOB07 | PT | 111 |
| Condition 1 | 19 |
VAP77777.1 | NNN | N-Nitrosonornicotine | STABILITY STUDY | HPHC | 0.0852 | ug/g |
| 0.0852 | 0.0852 | ug/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 20 | TOB07 | PT | 111 |
| Condition 1 | 20 |
VAP77777.1 | | 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 |
| 1 | Week 0 | 1 | | 21 | TOB07 | PT | 111 |
| Condition 1 | 21 |
VAP77777.1 | NNN | N-Nitrosonornicotine | STABILITY STUDY | HPHC | 0.0742 | ug/PUFF |
| 0.0742 | 0.0742 | ug/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 22 | TOB07 | PT | 111 |
| Condition 1 | 22 |
VAP77777.1 | NICKEL | Nickel | STABILITY STUDY | Extractables / Leachables | 0.0897 | ug/g |
| 0.0897 | 0.0897 | ug/g |
E| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 23 | TOB07 | PT | 111 |
| Condition 1 | 23 |
VAP77777.1 | | MASS | Mass | STABILITY STUDY |
| 3.87 | mg/PUFF | 0.0071 | 3.87 | 3.87 | mg/PUFF | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 24 | TOB07 | PT | 111 |
| Condition 1 | 24 |
VAP77777.1 | CHROMIUM | Chromium | STABILITY STUDY |
| NOT DETECTED |
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| NOT DETECTED |
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| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 25 | TOB07 | PT | 111 |
| Condition 1 | 25 |
VAP77777.1 | PH | pH | STABILITY STUDY |
| 7.15 |
|
| 7.15 | 7.15 |
| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 26 | TOB07 | PT | 111 |
| Condition 1 | 26 |
VAP77777.1 | | PH | pH | STABILITY STUDY |
| 7.24 |
|
| 7.24 | 7 |
.24| .24 |
| TPT LABCO | TLAE01_v2.1.pdf | AEROSOL |
| 1 | Week 0 | 1 | | 27 | TOB07 | PT | 111 |
| Condition 1 | 27 |
VAP77777.1 | | ENDTXN | Endotoxin | STABILITY STUDY | Toxins | NOT DETECTED |
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| NOT DETECTED |
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| TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 28 | TOB07 | PT | 111 |
| Condition 1 | 28 |
VAP77777.1 | | AEBPLCT | Aerobic Plate Count | STABILITY STUDY | Microbiological | <1 | CFU/mL |
| <1 |
| CFU/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 29 | TOB07 | PT | 111 |
| Condition 1 | 29 |
VAP77777.1 | | 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 |
| 1 | Week 0 | 1 | | 30 | TOB07 | PT | 111 |
| Condition 1 | 30 |
VAP77777.1 | ACTALD | Acetaldehyde | STABILITY STUDY | Aldehyde | 7.8 | ug/mL |
| 7.8 | 7.8 | ug/mL | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID |
| 1 | Week 0 | 1 | | 31 | TOB07 | PT | 111 |
| Condition |
131 | VAP77777.| 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 |
| 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.
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| Rows 1-9: | Show the PTTEST of Nicotine for Condition 1 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 Condition 2 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 Condition 3 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 | PTSEQPTREFID | PTGRPID | PTTESTCD | PTTEST | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPECPTNAM | PTSPCCNDPTXFN | PTMETHODPTSPEC | PTREPNUM | PTTPT | PTTPTNUM |
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| 1 | TOB07 | PT | 111 | Condition 1 | 211 | VAP77777.1 | 1 | NICOTINE | | 35.94 | mg/g | 35.94 | 35.94 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | Week 0 | 1 | | 2 | TOB07 | PT | 111 | Condition 1 | 212 | VAP77777.1 | 1 | | Nicotine | 35.46 | mg/g | 35.46 | 35.46 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | Week 0 | 1 | | 3 | TOB07 | PT | 111 | Condition 1 | 213 | VAP77777.1 | 1 | NICOTINE | Nicotine | 35.97 | mg/g | 35.97 | 35.97 | mg/gg | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | Week 0 | 1 | | 4 | TOB07 | PT | 111 | Condition 1 | 214 | VAP77777.1 | 1 | NICOTINE | Nicotine | 35.55 | mg/g | 35.55 | 35.55 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | Week 24 | 4 | | 5 | TOB07 | PT | 111 | Condition 1 | 215 | VAP77777.1 | 1 | NICOTINE | Nicotine | 35.88 | mg/g | 35.88 | 35.88 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | Week 24 | 4 | | 6 | TOB07 | PT | 111 | Condition 1 | 216 | VAP77777.1 | 1 | NICOTINE | Nicotine | 35.67 | mg/g | 35.67 | 35.67 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | Week 24 | 4 | | 7 | TOB07 | PT | 111 | Condition 1 | 217 | VAP77777.1 | 1 | NICOTINE | Nicotine | 36.11 | mg/g | 36.11 | 36.11 | mg/g | 36.11 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 1 | Week 52 | 9 | | 8 | TOB07 | PT | 111 | Condition 1 | 218 | VAP77777.1 | 1 | NICOTINE | Nicotine | 35.72 | mg/g | 35.72 | 35.72 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 2 | Week 52 | 9 | | 9 | TOB07 | PT | 111 | Condition 1 | 219 | VAP77777.1 | 1 | NICOTINE | Nicotine | 35.54 | mg/g | 35.54 | 35.54 | mg/g | TPT LABCO | TLEL01_v1.5.pdf | E-LIQUID | 3 | Week 52 | 9 | | 10 | TOB07 | PT | 111 | Condition 2 | 220 | VAP77777.1 | 3 | NICOTINE | | 0.1039 | mg/PUFF | 0.1039 | 0.1039 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 0 | 1 | | 11 | TOB07 | PT | 111 | Condition 2 | 221VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1142 | mg/PUFF | 0.1142 | 0.1142 | mg/puffpuff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 0 | 1 | | 12 | TOB07 | PT | 111 | Condition 2 | 222 | VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1282 | mg/PUFF | 0.1282 | 0.1282 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 0 | 1 | | 13 | TOB07 | PT | 111 | Condition 2 | 223 | VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1242 | mg/PUFF | 0.1242 | 0.1242 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 24 | 4 | | 14 | TOB07 | PT | 111 | Condition 2 | 224 | VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1084 | mg/PUFF | 0.1084 | 0.1084 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 24 | 4 | | 15 | TOB07 | PT | 111 | Condition 2 | 225VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1174 | mg/PUFF | 0.1174 | 0.1174 | mg/puff | 0.1174 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 24 | 4 | | 16 | TOB07 | PT | 111 | Condition 2 | 226 | VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1374 | mg/PUFF | 0.1374 | 0.1374 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 52 | 9 | | 17 | TOB07 | PT | 111 | Condition 2 | 227 | VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1364 | mg/PUFF | 0.1364 | 0.1364 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 52 | 9 | | 18 | TOB07 | PT | 111 | Condition 2 | 228 | VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1264 | mg/PUFF | 0.1264 | 0.1264 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 52 | 9 | | 19 | TOB07 | PT | 111 | Condition 2 | 229VAP77777.1 | 3 | NICOTINE | Nicotine | 0.1256 | mg/PUFF | 0.1256 | 0.1256 | mg/puffpuff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 0 | 1 | | 20 | TOB07 | PT | 111 | Condition 3 | 230 | VAP77777.1 | 4 | NICOTINE | Nicotine | 0.1236 | mg/PUFF | 0.1236 | 0.1236 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 0 | 1 | | 21 | TOB07 | PT | 111 | Condition 3 | 231 | VAP77777.1 | 4 | NICOTINE | Nicotine | 0.1126 | mg/PUFF | 0.1126 | 0.1126 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 0 | 1 | | 22 | TOB07 | PT | 111 | Condition 3 | 232 | VAP77777.1 | 4 | NICOTINE | Nicotine | 0.1334 | mg/PUFF | 0.1334 | 0.1334 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 24 | 4 | | 23 | TOB07 | PT | 111 | Condition 3 | 233VAP77777.1 | 4 | NICOTINE | Nicotine | 0.1134 | mg/PUFF | 0.1134 | 0.1134 | mg/puff | 0.1134 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 24 | 4 | | 24 | TOB07 | PT | 111 | Condition 3 | 234 | VAP77777.1 | 4 | NICOTINE | Nicotine | 0.1125 | mg/PUFF | 0.1125 | 0.1125 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 24 | 4 | | 25 | TOB07 | PT | 111 | Condition 3 | 235 | VAP77777.1 | 4 | NICOTINE | Nicotine | 0.1156 | mg/PUFF | 0.1156 | 0.1156 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 1 | Week 52 | 9 | | 26 | TOB07 | PT | 111 | Condition 3 | 236 | VAP77777.1 | 4 | NICOTINE | Nicotine | 0.1145 | mg/PUFF | 0.1145 | 0.1145 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 2 | Week 52 | 9 | | 27 | TOB07 | PT | 111 | Condition 3 | 237VAP77777.1 | 4 | NICOTINE | Nicotine | 0.1157 | mg/PUFF | 0.1157 | 0.1157 | mg/puff | TPT LABCO | TLAE01_v2.1.pdf | AEROSOL | 3 | Week 52 | 9 |
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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. Each of the parameters defining that storage condition are represented in ESPARMCD/ESPARM, with values and units shown in ESVAL/ESVALU.
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