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| Title | European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Palliative Care Version 1.0 (EORTC QLQ-C15-PAL V1.0)
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| CDISC Reference | Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Permission Status | Approved |
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| Team | Prostate Cancer Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 1.0 |
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| Status | DRAFT |
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| Date | 20212022-0904-2111 |
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| Notes | - This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.
- This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument.
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Revision History
| Date | Version |
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| 20212022-0904-2111 | 1.0 Draft |
© 2021 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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This document describes the CDISC implementation of the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Palliative Care Version 1.0 (EORTC QLQ-C15-PAL V1.0) instrument.
CDISC does did not modify this questionnaires, ratings, and scales (QRS) instruments instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
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The scale points include a 4-point Likert scale (1-4) and a 7-point numeric rating (1-7), with a definition of what is represented by the rating (e.g., 1 = "Not at all"). For the EORTC QLQ-C15-PAL V1.0, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.
The time period of evaluation for the EORTC QLQ-C15-PAL V1.0 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the EORTC QLQ-C15-PAL V1.0 is the past week for QSTESTCD="EOR0204" thru "EOR0215".
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
3.2 Example for the EORTC QLQ-C15-PAL V1.0 QS Domain Model
The EORTC QLQ-C15-PAL V1.0 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline and the second visit for a EORTC QLQ-C15-PAL V1.0 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.
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We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below. |
- QSTESTCD = "EOR0215" item is represented as a Numeric Rating Scale 7-Point item. Visual analog or numeric rating scales used within a questionnaire with a range of text and numeric values are indicated in the SUPPQS domain with:
QNAM=QSANTXLO QNAM=QSANTXHI
QNAM=QSANVLLO QNAM=QSANVLHI
By storing this information in SUPPQS, it is available for interpretation purposes. The SDS QS Team is researching alternative methods to handle this data in the future, but until a new method is identified, this will be the recommended approach.
- The low and high anchor text is stored in QSORRES with the numeric values stored in QSSTRESC and QSSTRESN. All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN.
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.
3.2 Example for the EORTC QLQ-C15-PAL V1.0 QS Domain Model
The EORTC QLQ-C15-PAL V1.0 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at the baseline and the second visit for a The table represents the items from the EORTC QLQ-C15-PAL V1.0 instrument. The subject did not fill out the instrument at VISITNUM = 2.The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results, matching the CRF item response text, are represented in QSORRES.This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC.
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We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below. |
The table represents the items from the EORTC QLQ-C15-PAL V1.0 instrument. The subject did not fill out the instrument at the scheduled VISITNUM = 2.
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSMETHOD | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | | 1 | STUDYX | QS | 2324-P0001 | 1 | EOR0201 | EOR02-Trouble Taking Short Walk Outside | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | 1 |
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| Y | 1 | 2015-11-1 |
| | 2 | STUDYX | QS | 2324-P0001 | 2 | EOR0202 | EOR02-Stay in Bed/Chair During the Day | EORTC QLQ-C15-PAL V1.0 | A Little | 2 | 2 |
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| Y | 1 | 2015-11-1 |
| | 3 | STUDYX | QS | 2324-P0001 | 3 | EOR0203 | EOR02-Need Help Eating/Dressing/Washing | EORTC QLQ-C15-PAL V1.0 | Quite a Bit | 3 | 3 |
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| Y | 1 | 2015-11-1 |
| | 4 | STUDYX | QS | 2324-P0001 | 4 | EOR0204 | EOR02-Were You Short of Breath | EORTC QLQ-C15-PAL V1.0 | Very Much | 4 | 4 |
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| Y | 1 | 2015-11-1 | -P1W | | 5 | STUDYX | QS | 2324-P0001 | 5 | EOR0205 | EOR02-Have You Had Pain | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | 1 |
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| Y | 1 | 2015-11-1 | -P1W | | 6 | STUDYX | QS | 2324-P0001 | 6 | EOR0206 | EOR02-Have You Had Trouble Sleeping | EORTC QLQ-C15-PAL V1.0 | A Little | 2 | 2 |
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| Y | 1 | 2015-11-1 | -P1W | | 7 |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT | | 1 | STUDYX | QS | 2324-P0001 | 17 | EOR0201EOR0207 | EOR02-Trouble Taking Short Walk OutsideHave You Felt Weak | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | Quite a Bit | 3 | 31 |
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| Y | 1 | 2015-11-1 | -P1W | | 82 | STUDYX | QS | 2324-P0001 | 28 | EOR0202EOR0208 | EOR02-Stay in Bed/Chair During the DayHave You Lacked Appetite | EORTC QLQ-C15-PAL V1.0 | A LittleVery Much | 242 | 4 |
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| Y | 1 | 2015-11-1 | -P1W | | 93 | STUDYX | QS | 2324-P0001 | 39 | EOR0203EOR0209 | EOR02-Need Help Eating/Dressing/WashingHave You Felt Nauseated | EORTC QLQ-C15-PAL V1.0 | Quite a Bit | 3 | Not at All | 1 | 13 |
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| Y | 1 | 2015-11-1 | -1P1W | | 410 | STUDYX | QS | 2324-P0001 | 410 | EOR0204EOR0210 | EOR02-Were You Short of BreathHave You Been Constipated | EORTC QLQ-C15-PAL V1.0 | Very MuchA Little | 424 | 2 |
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| Y | 1 | 2015-11-1 | -P1W | | 511 | STUDYX | QS | 2324-P0001 | 511 | EOR0205EOR0211 | EOR02-Have Were You Had PainTired | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | Quite a Bit | 3 | 31 |
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| Y | 1 | 2015-11-1 | -P1W | | 612 | STUDYX | QS | 2324-P0001 | 612 | EOR0206EOR0212 | EOR02-Have You Had Trouble SleepingPain Interfere Daily Activities | EORTC QLQ-C15-PAL V1.0 | A LittleVery Much | 242 | 4 |
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| Y | 1 | 2015-11-1 | -P1W | | 713 | STUDYX | QS | 2324-P0001 | 713 | EOR0207EOR0213 | EOR02-Have Did You Felt WeakFeel Tense | EORTC QLQ-C15-PAL V1.0 | Quite a Bit | 3 | Not at All | 1 | 13 |
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| Y | 1 | 2015-11-1 | -P1W | | 814 | STUDYX | QS | 2324-P0001 | 814 | EOR0208EOR0214 | EOR02-Have Did You Lacked AppetiteFeel Depressed | EORTC QLQ-C15-PAL V1.0 | Very MuchA Little | 424 | 2 |
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| Y | 1 | 2015-11-1 | -P1W | | 915 | STUDYX | QS | 2324-P0001 | 915 | EOR0209EOR0215 | EOR02-Have You Felt NauseatedRate Your Overall Quality of Life | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | 1Excellent | 7 | 7 |
| NUMERICAL RATING SCALE 7-POINT | Y | 1 | 2015-11-1 | -P1W | | 1016 | STUDYX | QS | 2324-P0001 | 1016 | EOR0210EOR0201 | EOR02-Have You Been ConstipatedTrouble Taking Short Walk Outside | EORTC QLQ-C15-PAL V1.0 | A Little |
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| 2NOT DONE |
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| 2 | Y | 1 | 2015-11-1 | -P1W | 8 |
| | 1711 | STUDYX | QS | 2324-P0001 | 1117 | EOR0211EOR0202 | EOR02-Were You TiredStay in Bed/Chair During the Day | EORTC QLQ-C15-PAL V1.0 | Quite a Bit | 3 | 3 | Y | 1 |
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| NOT DONE |
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| 2 | 2015-11-1 | -P1W | 8 |
| | 1812 | STUDYX | QS | 2324-P0001 | 1218 | EOR0212EOR0203 | EOR02-Pain Interfere Daily ActivitiesNeed Help Eating/Dressing/Washing | EORTC QLQ-C15-PAL V1.0 | Very Much | 4 | 4 | Y | 0 |
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| NOT DONE |
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| 21 | 2015-11-18-P1W |
| | 19 | 13 | STUDYX | QS | 2324-P0001 | 1319 | EOR0213EOR0204 | EOR02-Did You Feel TenseWere You Short of Breath | EORTC QLQ-C15-PAL V1.0 | Not at All | 1 | 1 | Y |
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| NOT DONE |
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| 21 | 2015-11-18 | -P1W | | 1420 | STUDYX | QS | 2324-P0001 | 1420 | EOR0214EOR0205 | EOR02-Did Have You Feel DepressedHad Pain | EORTC QLQ-C15-PAL V1.0 | A Little |
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| 2NOT DONE |
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| 2 | Y | 1 | 2015-11-18 | -P1W | | 1521 | STUDYX | QS | 2324-P0001 | 1521 | EOR0215EOR0206 | EOR02-Rate Your Overall Quality of LifeHave You Had Trouble Sleeping | EORTC QLQ-C15-PAL V1.0 | Excellent | 7 | 7 | Y |
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| NOT DONE |
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| 21 | 2015-11-18 | -P1W | | 1622 | STUDYX | QS | 2324-P0001 | 1622 | EOR0201EOR0207 | EOR02-Trouble Taking Short Walk OutsideHave You Felt Weak | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W | | 2317 | STUDYX | QS | 2324-P0001 | 1723 | EOR0202EOR0208 | EOR02-Stay in Bed/Chair During the DayHave You Lacked Appetite | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W | | 2418 | STUDYX | QS | 2324-P0001 | 1824 | EOR0203EOR0209 | EOR02-Need Help Eating/Dressing/WashingHave You Felt Nauseated | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W | | 1925 | STUDYX | QS | 2324-P0001 | 1925 | EOR0204EOR0210 | EOR02-Were You Short of BreathHave You Been Constipated | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W | | 2026 | STUDYX | QS | 2324-P0001 | 2026 | EOR0205EOR0211 | EOR02-Have Were You Had PainTired | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W | | 2127 | STUDYX | QS | 2324-P0001 | 2127 | EOR0206EOR0212 | EOR02-Have You Had Trouble SleepingPain Interfere Daily Activities | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W | | 2228 | STUDYX | QS | 2324-P0001 | 2228 | EOR0207EOR0213 | EOR02-Have Did You Felt WeakFeel Tense | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W | | 2329 | STUDYX | QS | 2324-P0001 | 2329 | EOR0208EOR0214 | EOR02-Have Did You Lacked AppetiteFeel Depressed | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE |
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| 2 | 2015-11-8 | -P1W | | 2430 | STUDYX | QS | 2324-P0001 | 2430 | EOR0209EOR0215 | EOR02-Have You Felt NauseatedRate Your Overall Quality of Life | EORTC QLQ-C15-PAL V1.0 |
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| NOT DONE | NUMERICAL RATING SCALE 7-POINT |
| 2 | 2015-11-8 | -P1W | 25 | STUDYX | QS | 2324-P0001 | 25 | EOR0210 | EOR02-Have You Been Constipated | EORTC QLQ-C15-PAL V1.0 | NOT DONE | 2 | 2015-11-8 | -P1W | 26 | STUDYX | QS | 2324-P0001 | 26 | EOR0211 | EOR02-Were You Tired | EORTC QLQ-C15-PAL V1.0 | NOT DONE | 2 | 2015-11-8 | -P1W |
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The anchor text and numeric values for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.
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| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG27 | | STUDYX | QS | 2324-P0001 | 27QSTESTCD | EOR0212 | EOR02-Pain Interfere Daily Activities | EORTC QLQ-C15-PAL V1.0 | NOT DONE | 2 | 2015-11-8 | -P1W | EOR0215 | QSANTXLO | Anchor Text Low | VERY POOR | CRF28 | | STUDYX | QS | 2324-P0001 | 28QSTESTCD | EOR0213 | EOR02-Did You Feel Tense | EORTC QLQ-C15-PAL V1.0 | NOT DONE | 2 | 2015-11-8 | -P1W | 29 | EOR0215 | QSANTXHI | Anchor Text High | EXCELLENT | CRF | | STUDYX | QS | 2324-P0001 | 29 | EOR0214 | EOR02-Did You Feel Depressed | EORTC QLQ-C15-PAL V1.0 | NOT DONE | 2 | 2015-11-8 | -P1W | -P0001 | QSTESTCD | EOR0215 | QSANVLLO | Anchor Value Low | 1 | CRF30 | | STUDYX | QS | 2324-P0001 | 30QSTESTCD | EOR0215 | EOR02-Rate Your Overall Quality of Life | EORTC QLQ-C15-PAL V1.0 | NOT DONE | 2 | 2015-11-8 | QSANVLHI | Anchor Value High | 7 | CRF-P1W |
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4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.
QSTESTCD ="EOR0201" QSTEST = "EOR02-Trouble Taking Short Walk Outside" through
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QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.
QSTESTCD ="EOR0201" QSTEST = "EOR02-Trouble Taking Short Walk Outside" through
QSTESTCD = "EOR0214" QSTEST = "EOR02-Did You Feel Depressed"
| QSORRES | QSSTRESC | QSSTRESN |
| Not at All | 1 | 1 |
| A Little | 2 | 2 |
| Quite a Bit | 3 | 3 |
| Very Much | 4 | 4 |
QSTESTCD = "EOR0215" QSTEST = "EOR02-
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Rate Your Overall Quality of Life"
| QSORRES | QSSTRESC | QSSTRESN |
| Not at AllVery poor | 1 | 1 |
| A Little2 | 2 | 2 |
| Quite a Bit | 3 | 3 |
| Very Much | 4 | 4 |
QSTESTCD = "EOR0215" QSTEST = "EOR02-Rate Your Overall Quality of Life"
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5 Supplemental Qualifier Name Codes
The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.
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| QNAM | QLABEL | QVAL |
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| QSANTXLO | Anchor Text Low | VERY POOR | QSANTXHI | Anchor Text High | EXCELLENT | QSANVLLO | Anchor Value Low | 1 | QSANVLHI | Anchor Value High | |
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End of Document