...
| Dataset wrap |
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| Rowcaps |
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| Rows 7-8: | Represent the conditional branching on data entry where Ideation With Intent, No Plan is "No" and the associated description is missing. | | Rows 9-10: | Represent the conditional branching on data entry where Ideation With Plan/Intent is "No" and the associated description is missing. | | Rows 25-27: | Represent the conditional branching on data entry where Aborted Attempt is "No". The Number of Aborted Attempts and the associated description are missing. | | Rows 40-79: | Show the subject was not evaluated on this instrument at the baseline visit. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. |
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| Dataset2 |
|---|
| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | QSLOBXFL | VISITNUM | QSDTC |
QSEVLINT| QSEVINTX | | 1 | STUDYX | QS | 2324-P0001 | 1 |
CSS0901CSS09| CSS01-Wish to be Dead | C-SSRS |
SCREENING| BASELINE | SUICIDAL IDEATION | Yes | Y |
|
|
| Y | 1 |
20130913-P1M| LIFETIME | | 2 | STUDYX | QS | 2324-P0001 | 2 |
CSS0901ACSS09| CSS01-Wish to be Dead, Describe | C-SSRS |
SCREENING| BASELINE | SUICIDAL IDEATION |
Wish dead | | Fall asleep and not wake up | Fall asleep and not wake up |
Wish dead20130913-P1M| LIFETIME | | 3 | STUDYX | QS | 2324-P0001 | 3 |
CSS0902CSS09Spec Suicid | Specific Suicidal Thought | C-SSRS |
SCREENING| BASELINE | SUICIDAL IDEATION | Yes | Y |
|
|
| Y | 1 |
20130913-P1M| LIFETIME | | 4 | STUDYX | QS | 2324-P0001 | 4 |
CSS0902ACSS09Spec Describe SCREENING| BASELINE | SUICIDAL IDEATION | I |
have killing myself| taking an overdose but I never made a specific plan as to when | I thought about taking an overdose but I never made a specific plan as to when |
I have thought about killing myself20130913-P1M| LIFETIME | | 5 | STUDYX | QS | 2324-P0001 | 5 |
CSS0903 | CSS09-Idea, No Intent, No Plan| CSS0103 | CSS01-Suicidal Ideation-No Intent | C-SSRS |
SCREENING| BASELINE | SUICIDAL IDEATION |
YesY20130913-P1M | LIFETIME | | 6 | STUDYX | QS | 2324-P0001 | 6 |
CSS0903A | CSS09-Idea, | CSS0103A | CSS01-Suicidal Ideation-No Intent, |
No Plan, Describe SCREENING| BASELINE | SUICIDAL IDEATION |
I thought about taking an overdose but I never made a specific plan | I thought about taking an overdose but I never made a specific plan | Y | Y | 2013-09-13 | |
|
|
| NOT DONE |
|
| 1 | 2022-08-19 | LIFETIME |
-P1MCSS0904CSS09Idea, | Ideation With Intent, No Plan | C-SSRS |
SCREENING| BASELINE | SUICIDAL IDEATION |
NoN20130913-P1M | LIFETIME | | 8 | STUDYX | QS | 2324-P0001 | 8 |
CSS0904ACSS09Idea, , , Describe SCREENING| BASELINE | SUICIDAL IDEATION |
NOT DONE | 1 | 2013-09-13 | | I’ve thought about killing myself and how | I’ve thought about killing myself and how |
|
|
| Y | 1 | 2022-08-19 | LIFETIME |
-P1MCSS0905CSS09Idea, , SCREENING| BASELINE | SUICIDAL IDEATION | No | N |
|
|
| Y | 1 |
20130913-P1M| LIFETIME | | 10 | STUDYX | QS | 2324-P0001 | 10 |
CSS0905ACSS09Idea, , Describe SCREENING| BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 1 |
20130913-P1M | LIFETIME | | 11 | STUDYX | QS | 2324-P0001 | 11 |
CSS0906CSS09 Idea SCREENING| BASELINE | INTENSITY OF IDEATION |
22220130913-P1M| LIFETIME | | 12 | STUDYX | QS | 2324-P0001 | 12 |
CSS0906ACSS09 Idea Desc SCREENING| BASELINE | INTENSITY OF IDEATION |
Some intent to act on suicidal thoughts | Some intent to act on suicidal thoughts| Wish to be Dead | Wish to be Dead |
|
|
| Y | 1 |
20130913-P1M| LIFETIME | | 13 | STUDYX | QS | 2324-P0001 | 13 |
CSS0907CSS09 Idea| Ideation, Frequency | C-SSRS |
SCREENING| BASELINE | INTENSITY OF IDEATION |
2-5 times in 3320130913-P1M | LIFETIME | | 14 | STUDYX | QS | 2324-P0001 | 14 |
CSS0908CSS09 Idea SCREENING| BASELINE | INTENSITY OF IDEATION |
Less than 1 hour/some of the time | 2 | 220130913-P1M| LIFETIME | | 15 | STUDYX | QS | 2324-P0001 | 15 |
CSS0909CSS09 Idea Controllability SCREENING| BASELINE | INTENSITY OF IDEATION |
Can | Does not attempt to control thoughts |
with a lot of difficulty4420130913-P1M| LIFETIME | | 16 | STUDYX | QS | 2324-P0001 | 16 |
CSS0910CSS09 Idea| Ideation, Deterrents | C-SSRS |
SCREENING| BASELINE | INTENSITY OF IDEATION |
Deterrents definitely did not stop you | 5 | 520130913-P1M| LIFETIME | | 17 | STUDYX | QS | 2324-P0001 | 17 |
CSS0911CSS09 Idea SCREENING| BASELINE | INTENSITY OF IDEATION | Mostly to get attention, revenge or a reaction from others | 2 | 2 |
|
| Y | 1 |
20130913-P1M| LIFETIME | | 18 | STUDYX | QS | 2324-P0001 | 18 |
CSS0912CSS09| CSS01-Actual Attempt | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
|
|
| Y | 1 |
20130913-P2Y| LIFETIME | | 19 | STUDYX | QS | 2324-P0001 | 19 |
CSS0913CSS09| CSS01-Number of Actual Attempts | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
22220130913-P2Y| LIFETIME | | 20 | STUDYX | QS | 2324-P0001 | 20 |
CSS0913ACSS09| CSS01-Actual Attempt, Describe | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
Try to get injured to get attention | Try to get injured to get attention| To feel better | To feel better |
|
|
| Y | 1 |
20130913-P2Y| LIFETIME | | 21 | STUDYX | QS | 2324-P0001 | 21 |
CSS0914CSS09injur SCREENING| BASELINE | SUICIDAL BEHAVIOR |
YesY20130913-P2Y| LIFETIME | | 22 | STUDYX | QS | 2324-P0001 | 22 |
CSS0915CSS09| CSS01-Interrupted Attempt | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
|
|
| Y | 1 |
20130913-P2Y| LIFETIME | | 23 | STUDYX | QS | 2324-P0001 | 23 |
CSS0916CSS09 Interrupt | Interrupted Attempts | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR | 1 | 1 | 1 |
|
| Y | 1 |
20130913-P2Y| LIFETIME | | 24 | STUDYX | QS | 2324-P0001 | 24 |
CSS0916ACSS09| CSS01-Interrupted Attempt, Describe | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR | Stopped from overdose | Stopped from overdose |
|
|
| Y | 1 |
20130913-P2Y| LIFETIME | | 25 | STUDYX | QS | 2324-P0001 | 25 |
CSS0917CSS09| CSS01-Aborted Attempt | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
NoN20130913-P2Y| LIFETIME | | 26 | STUDYX | QS | 2324-P0001 | 26 |
CSS0918CSS09| CSS01-Number of Aborted Attempts | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
NOT DONE20130913-P2Y| LIFETIME | | 27 | STUDYX | QS | 2324-P0001 | 27 |
CSS0918ACSS09| CSS01-Aborted Attempt, Describe | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
| Parent found my letters | Parent found my letters |
|
|
| Y |
NOT DONE20130913-P2Y| LIFETIME | | 28 | STUDYX | QS | 2324-P0001 | 28 |
CSS0919CSS09| CSS01-Preparatory Acts/Behavior | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
YesY20130913-P2Y| LIFETIME | | 29 | STUDYX | QS | 2324-P0001 | 29 |
CSS0919ACSS09| CSS01-Preparatory Acts/Behavior, Descr | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
Buying pills | Buying pills | Y | 20130913-P2Y| LIFETIME | | 30 | STUDYX | QS | 2324-P0001 | 30 |
CSS0920CSS09| CSS01-Suicidal Behavior | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
NoN20130913-P2Y| LIFETIME | | 31 | STUDYX | QS | 2324-P0001 | 31 |
CSS0921ACSS09| CSS01-Most Recent Attempt Date | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
201011092010110920130913-P2Y| LIFETIME | | 32 | STUDYX | QS | 2324-P0001 | 32 |
CSS0921BCSS09| CSS01-Most Recent Attempt Damage | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
Minor | Moderately severe physical damage |
1 | | ; medical hospitalization and likely intensive care required | 3 | 3 |
120130913-P2Y| LIFETIME | | 33 | STUDYX | QS | 2324-P0001 | 33 |
CSS0921CCSS09| CSS01-Most Recent Attempt Potential | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
Behavior likely to result in injury but not likely to cause death1 | Y | 1 | 2013-09-13 | -P2YCSS0922ACSS09| CSS01-Most Lethal Attempt Date | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
200903272009032720130913-P2Y| LIFETIME | | 35 | STUDYX | QS | 2324-P0001 | 35 |
CSS0922BCSS09| CSS01-Most Lethal Attempt Damage | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
No or very minor physical damage| ; medical hospitalization with intensive care required | 4 | 4 |
0 | 020130913-P2Y| LIFETIME | | 36 | STUDYX | QS | 2324-P0001 | 36 |
CSS0922CCSS09| CSS01-Most Lethal Attempt Potential | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
Behavior not likely to result in injury | 0 | 0 | Y | 1 | 2013-09-13 |
|
|
| NOT DONE |
|
| 1 | 2022-08-19 | LIFETIME |
-P2YCSS0923ACSS09| CSS01-First Attempt Date | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
20091220091220130913-P2Y| LIFETIME | | 38 | STUDYX | QS | 2324-P0001 | 38 |
CSS0923BCSS09| CSS01-First Attempt Damage | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR | No physical damage or very minor physical damage | 0 | 0 |
|
| Y | 1 |
20130913-P2Y| LIFETIME | | 39 | STUDYX | QS | 2324-P0001 | 39 |
CSS0923CCSS09| CSS01-First Attempt Potential | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR | Behavior not likely to result in injury |
but not likely to cause death | 0 | 0 |
|
| Y | 1 | 2022-08-19 | LIFETIME | | 40 | STUDYX | QS | 2324-P0002 | 1 | CSS0101 | CSS01-Wish to be Dead | C-SSRS BASELINE | SUICIDAL IDEATION | No | N |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 41 | STUDYX | QS | 2324-P0002 | 2 | CSS0101A | CSS01-Wish to be Dead, Describe | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 42 | STUDYX | QS | 2324-P0002 | 3 | CSS0102 | CSS01-Non-Specific Suicidal Thought | C-SSRS BASELINE | SUICIDAL IDEATION | No | N |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 43 | STUDYX | QS | 2324-P0002 | 4 | CSS0102A | CSS01-Non-Specific Suicid Thought, Descr | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 44 | STUDYX | QS | 2324-P0002 | 5 | CSS0103 | CSS01-Suicidal Ideation-No Intent | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME |
| … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | ... | | 56 | STUDYX | QS | 2324-P0002 | 17 | CSS0111 | CSS01-Most Severe Ideation, Reasons | C-SSRS BASELINE | INTENSITY OF IDEATION |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 57 | STUDYX | QS | 2324-P0002 | 18 | CSS0112 | CSS01-Actual Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 58 | STUDYX | QS | 2324-P0002 | 19 | CSS0113 | CSS01-Number of Actual Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 59 | STUDYX | QS | 2324-P0002 | 20 | CSS0113A | CSS01-Actual Attempt, Describe | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 60 | STUDYX | QS | 2324-P0002 | 21 | CSS0114 | CSS01-Non-suicidal Self-injurious Behav | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 61 | STUDYX | QS | 2324-P0002 | 22 | CSS0115 | CSS01-Interrupted Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 62 | STUDYX | QS | 2324-P0002 | 23 | CSS0116 | CSS01-Number of Interrupted Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 63 | STUDYX | QS | 2324-P0002 | 24 | CSS0116A | CSS01-Interrupted Attempt, Describe | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 64 | STUDYX | QS | 2324-P0002 | 25 | CSS0117 | CSS01-Aborted Attempt | C-SSRS BASELINE | SUICIDAL BEHAVIOR | No | N |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 65 | STUDYX | QS | 2324-P0002 | 26 | CSS0118 | CSS01-Number of Aborted Attempts | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 66 | STUDYX | QS | 2324-P0002 | 27 | CSS0118A | CSS01-Aborted Attempt, Describe | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 67 | STUDYX | QS | 2324-P0002 | 28 | CSS0119 | CSS01-Preparatory Acts/Behavior | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 68 | STUDYX | QS | 2324-P0002 | 29 | CSS0119A | CSS01-Preparatory Acts/Behavior, Descr | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Bought pills, Bought a gun, suicide note | Bought pills, Bought a gun, suicide note |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 69 | STUDYX | QS | 2324-P0002 | 30 | CSS0120 | CSS01-Suicidal Behavior | C-SSRS BASELINE | SUICIDAL BEHAVIOR | Yes | Y |
|
|
| Y | 1 | 2022-07-13 | LIFETIME | | 70 | STUDYX | QS | 2324-P0002 | 31 | CSS0121A | CSS01-Most Recent Attempt Date | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 71 | STUDYX | QS | 2324-P0002 | 32 | CSS0121B | CSS01-Most Recent Attempt Damage | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME | | 72 | STUDYX | QS | 2324-P0002 | 33 | CSS0121C | CSS01-Most Recent Attempt Potential | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 1 | 2022-07-13 | LIFETIME |
| … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | … | | 78 | STUDYX | QS | 2324-P0002 | 39 | CSS0123C | CSS01-First Attempt Potential | C-SSRS BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
|
| 1 |
|
| | 79 | STUDYX | QS | 2324-P0002 | 40 | CSS0101 | CSS01-Wish to be Dead | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
| | 80 | STUDYX | QS | 2324-P0002 | 41 | CSS0101A | CSS01-Wish to be Dead, Describe | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
| | 81 | STUDYX | QS | 2324-P0002 | 42 | CSS0102 | CSS01-Non-Specific Suicidal Thought | C-SSRS BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
|
| 2 |
|
| | 82 |
1 | 1 | Y | 1 | 2013-09-13 | -P2Y | 401CSS0901CSS09-Wish to be Dead| CSS01-Non-Specific Suicid Thought, Descr | C-SSRS |
SCREENING| BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
1412CSS0901A | CSS09-Wish to be Dead, Describe| CSS0103 | CSS01-Suicidal Ideation-No Intent | C-SSRS |
SCREENING| BASELINE | SUICIDAL IDEATION |
|
|
| NOT DONE |
179… | 39CSS0923CCSS09| CSS01-First Attempt Potential | C-SSRS |
SCREENING| BASELINE | SUICIDAL BEHAVIOR |
|
|
| NOT DONE |
1 |
|
The SUPPQS dataset shows the items in the QS dataset which have assigned responses due to conditional branching.
| Dataset wrap |
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| Dataset2 |
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| | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | | STUDYX | QS | 2324-P0001 | QSSEQ | 6 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0001 | QSSEQ | 10 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0001 | QSSEQ | 29 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0001 | QSSEQ | 33 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0001 | QSSEQ | 36 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 2 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 4 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 5 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | … | … | … | … |
| … | … | … | … | | STUDYX | QS | 2324-P0002 | QSSEQ | 17 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 19 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 20 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 23 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 24 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 26 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 27 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 31 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 32 | QSCBRFL | Conditional Branching Item Indicator | Y | ASSIGNED | | STUDYX | QS | 2324-P0002 | QSSEQ | 33 | QSCBRFL | Conditional Branching Item Indicator | Y | |
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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.
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