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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 | PTSEQ | PTREFID | PTGRPID | PTTESTCD | PTTEST | PTTSTCND | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU | PTSPEC | PTSPCCND | PTMETHOD | PTREPNUM | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | 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 | PT | 212 | VAP77777.1 | 1 | | Nicotine | E-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 | 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 | 214 | 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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| 1 | Week 24 | 4 | 5 | TOB07 | PT | 215 | 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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| 2 | Week 24 | 4 | 6 | TOB07 | PT | 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 | 217 | 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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| 1 | Week 52 | 9 | 8 | TOB07 | PT | 218 | 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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| 2 | Week 52 | 9 | 9 | TOB07 | PT | 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 | 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 | 221 | 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 0 | 1 | 12 | TOB07 | PT | 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 | 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 | 224 | 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 24 | 4 | 15 | TOB07 | PT | 225 | 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 24 | 4 | 16 | TOB07 | PT | 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 | 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 | 228 | 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 52 | 9 | 19 | TOB07 | PT | 229 | 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 0 | 1 | 20 | TOB07 | PT | 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 | 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 | 232 | 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 24 | 4 | 23 | TOB07 | PT | 233 | 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 24 | 4 | 24 | TOB07 | PT | 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 | 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 | 236 | 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 52 | 9 | 27 | TOB07 | PT | 237 | 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 52 | 9 |
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The Trial Test Lookup Conditions (TL) dataset allows for listing the attributes of the testing regimens used in tobacco product testing when the details are too long and variable for representing as a single value in the PTTSTCND variable in a PT dataset.
The example below shows the attributes of the testing regimen identified as PTTSTCND="E-Liquid Standard Aerosol Condition" (see e-liquid stability study pt.xpt example). Note that the combination of TLVAR1TCVAR1="PTTSTCND" and TLVRVAL1TCVRVAL1="E-Liquid Standard (Long Term) Condition" identifies the specific testing regimen shown in PTTSTCND as the focus of the testing regimen parameters listed in TLPARMCD/TLPAM. TLVAL and TVALU show the specific values and units (respectively, where applicable) for the given parameter.one testing regimen shown in the PT stability study above.
(We've added TLVALU which was not originally part of the TL draft domain. May propose elevating this structure to a "Trial Lookup" observational class, within which some domains would allow for TLVALU)
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Dataset2 |
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Row | STUDYID | DOMAIN | RDOMAIN | TLVAR1TCVAR1 | TLVRVAL1TCVRVAL1 | TLSEQTCSEQ | TLGRPIDTCGRPID | TLPARMCDTCPARMCD | TLPARMTCPARM | TLVALTCVAL | TLVALUTCVALU |
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1 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 1 |
| PUFFPROF | Puff Profile | SQUARE |
| 2 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 2 |
| PUFFDUR | Puff Duration | 1.25 | sec | 3 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 3 |
| PUFFINT | Puff Interval | 3 | PUFF/min | 4 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 4 |
| PUFFBLCK | Puff Block | 25 | % | 5 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 5 |
| NUMPUFF | Total Number of Puffs | 200 | PUFF | 6 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 6 |
| PUFFVOL | Puff Volume | 10 | mL | 7 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 7 |
| PUFFRNG | Puff Range | 100-200 |
| 8 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 8 | 1 | PUFFPAUS | Puff Pause | 60 | s | 9 | TOB07 | TL | PT | PTTSTCND | E-Liquid Standard (Long Term) Condition | 9 | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF |
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