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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HL148907-01 | U.S. NIH Grant/Contract | View source | |
| NCI-2024-06207 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Food and Drug Administration (FDA) | FED |
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E-cigarette (EC) use continues to increase among youth, and EC may be detrimental to youth respiratory health. Public health officials and the Food and Drug Administration (FDA) can now regulate ECs. The proposed study uses naturalistic assessments called ecological momentary assessment (EMA) to understand how ECs use may impact the respiratory health of youth and young adult users compared to never-using peers.
Using a prospective longitudinal design, 150 youth and young adults aged 18-25 years (100 exclusive-EC users; 50 never-users) will complete 5 sessions (baseline, 3-,6-, 9-, and 12-months). Sessions will include naturalistic measures such as measures of respiratory health, questionnaires, and nasal epithelial lining fluid (NELF) nasal samples. To assess acute changes in pulmonary functioning related to tobacco product use, participants will complete twice daily EMA and home-based spirometry for the 2 weeks following the Day 1 session and the 2 weeks prior to each follow-up zoom session. Never-users will participate in a brief 15-30-minute individual interview consisting of questions related to reasons for never-EC use and other protective factors that will be used to build future prevention messaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Current E-Cigarette Users | Monitoring current e-cigarette users | ||
| Never E-Cigarette / Tobacco Users | Monitoring never users of any tobacco or e-cigarette products. |
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| Measure | Description | Time Frame |
|---|---|---|
| Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC) | Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV) | Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Level of Dependence by Product Type Will be Examined. | Changes in product use evaluated with an evaluation of the changes in dependence using the Hooked on Nicotine Checklist (HONC). Scores range from 0 to 10 with higher values indicating greater levels of dependence. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - IL-6 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine). | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - IL-8 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
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Inclusion Criteria:
Exclusion Criteria:
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The present proposal, a study of e-cigarette use among youth and young adults, will include both females and racial/ethnic minorities.
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| Name | Affiliation | Role |
|---|---|---|
| Alayna Tackett, PhD | The Ohio State Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43214 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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Participants are assigned to a study arm (Current E-Cigarette User or Never E-Cigarette/Tobacco User) after completion of the baseline survey. 10 Participants were found to be ineligible due to their tobacco use patterns reported at baseline, these participants were excluded from the study prior to being assigned to a study arm and are not included in the participant flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | Current E-Cigarette Users | Monitoring current e-cigarette users |
| FG001 | Never E-Cigarette / Tobacco Users | Monitoring never users of any tobacco or e-cigarette products. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only the 105 participants who were eligible at baseline are included. 10 participants were found to be ineligible after completing the baseline questionnaire.
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| ID | Title | Description |
|---|---|---|
| BG000 | Current E-Cigarette Users | Monitoring current e-cigarette users |
| BG001 | Never E-Cigarette / Tobacco Users | Monitoring never users of any tobacco or e-cigarette products. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spirometry to Measure the Change From Baseline in Forced Vital Capacity (FVC) | Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session. | Only participants who were eligible at baseline and provided spirometry measurements are included. The number of participants at follow-up is less than that at baseline due to loss to follow-up over time. | Posted | Mean | Standard Deviation | liter | Baseline, 3-month, 6-month, 9-month, 12-month | Forced Expiratory Maneuvers | Forced Expiratory Maneuvers |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Current E-Cigarette Users | Monitoring current e-cigarette users | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alayna Tackett | Ohio State University Comprehensive Cancer Center | 614-558-2679 | alayna.tackett@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2024 | May 31, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 3, 2024 | May 31, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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salivary collection, respiratory health
| Respiratory Health Measures by Nasal Swab - TNF-alpha | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - IL-4 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - IL-5 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - IL-10 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - IL-13 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - TARC | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - Eotaxin | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - MCP-1 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - MCP-4 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Respiratory Health Measures by Nasal Swab - Cotinine | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | Baseline, 3-month, 6-month, 9-month, 12-month |
| Moved Abroad |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Days used e-cigarettes in past 30 days | Mean | Standard Deviation | days |
|
Monitoring never users of any tobacco or e-cigarette products. |
|
|
| Primary | Spirometry to Measure the Change From Baseline in Forced Expiratory Volume (FEV) | Participants will complete twice daily home-based spirometry (a pulmonary function diagnostic test) for the 2 weeks prior to each follow-up session. | Only participants who were eligible at baseline and provided spirometry measurements are included. The number of participants at follow-up is less than that at baseline due to loss to follow-up over time. | Posted | Mean | Standard Deviation | Liters | Baseline, 3-month, 6-month, 9-month, 12-month | Forced Expiratory Maneuvers | Forced Expiratory Maneuvers |
|
|
|
| Primary | Level of Dependence by Product Type Will be Examined. | Changes in product use evaluated with an evaluation of the changes in dependence using the Hooked on Nicotine Checklist (HONC). Scores range from 0 to 10 with higher values indicating greater levels of dependence. | Only participants who were eligible and using e-cigarettes at baseline are included. The number of participants at follow-up is less than that at baseline due to loss to follow-up over time. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - IL-6 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine). | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - IL-8 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - TNF-alpha | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - IL-4 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - IL-5 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - IL-10 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - IL-13 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - TARC | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - Eotaxin | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| Primary | Respiratory Health Measures by Nasal Swab - MCP-1 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
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| Primary | Respiratory Health Measures by Nasal Swab - MCP-4 | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a NELF sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
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| Primary | Respiratory Health Measures by Nasal Swab - Cotinine | Nasal epithelial lining fluid (NELF) samples will provide objective data on respiratory health (e.g., markers of inflammation, host defense, and lung injury) and will provide estimates of nicotine exposure/use via cotinine (i.e., the predominate metabolite of nicotine) will also be examined to provide objective indicators of recency of EC and/or OTP use. | The population of participants who both attended their study visit and were able to provide a sample is analyzed. Note that not all participants provided a sample at all visits. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 3-month, 6-month, 9-month, 12-month |
|
|
|
| 52 |
| 0 |
| 52 |
| 11 |
| 52 |
| EG001 | Never E-Cigarette / Tobacco Users | Monitoring never users of any tobacco or e-cigarette products. | 0 | 53 | 0 | 53 | 0 | 53 |
| Sore or dry mouth and throat | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Dizziness | General disorders | Systematic Assessment |
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| Sleepiness | General disorders | Systematic Assessment |
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| Sleeplessness | General disorders | Systematic Assessment |
|
| Heart palpitations | Cardiac disorders | Systematic Assessment |
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| Breathing difficulties | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Shortness of breath | General disorders | Systematic Assessment |
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| Allergies | Immune system disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Throat tightness | General disorders | Systematic Assessment |
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