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Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings (MTQT)

Primary Purpose

Tobacco Use Disorder, Mental Illness, Recurring Major Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quit on the Go App (formerly "Learn to Quit " App)
Brief advice
Nicotine patch
Smartphone coaching
Nicotine gum
Nicotine Lozenges
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Current DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder
  2. Functional impairment as indicated by a score of_2 or greater on the WHODAS 8 item version
  3. Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months;
  4. Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months;
  5. Age 18 and older;
  6. Willing and medically eligible to use NRT;
  7. Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.).

Exclusion Criteria

  1. Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year.
  2. Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998);
  3. Being pregnant or the intention to become pregnant in the next 6 months;
  4. Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation;
  5. Currently using e-cigarettes or other tobacco products besides cigarettes > 10 days in the past 30 days.

Sites / Locations

  • Duke UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

"Quit on the Go" (formerly "Learn to Quit")

Brief Advice (Standard of Care)

Arm Description

A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum). Participants also receive technical smartphone coaching for the first 4 weeks of the study.

Brief Advice and Combined Nicotine Replacement Therapy (patches and gum or lozenges) has been recommended by the US Clinical Practice Guidelines for patients with psychiatric illness. Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt. The intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum).

Outcomes

Primary Outcome Measures

CO-verified 7-day point-prevalence abstinence at 6-month follow-up
Abstinence is determined by a self-report of not smoking any tobacco product for greater than or equal to 7 days prior to Week 24 and biochemically verified by an expired carbon monoxide breath test reading of < 5 ppm at Week 24. If the participant does not meet both criteria, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 5 ppm.

Secondary Outcome Measures

Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Change in average number of cigarettes smoked per day
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Average number of quit attempts per group
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Average number of quit attempts per group
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Average number of quit attempts per group
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Time to 7-day relapse
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
Time to 7-day relapse
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
Time to 7-day relapse
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
30-day point prevalence abstinence rates
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the timepoint.
Biochemically confirmed 30-day point prevalence abstinence rates
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the time point. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Biochemically confirmed 30-day point prevalence abstinence rates
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the time point. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Prolonged abstinence rates
Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period.
Prolonged abstinence rates
Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period.
Prolonged abstinence rates
Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period.
Continuous abstinence rates
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point.
Continuous abstinence rates
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. Biochemically verified (CO < 5 ppm).
Continuous abstinence rates
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. Biochemically verified (CO < 5 ppm).

Full Information

First Posted
August 26, 2021
Last Updated
April 6, 2023
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), University at Buffalo, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05030272
Brief Title
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Acronym
MTQT
Official Title
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2021 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH), University at Buffalo, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study team will conduct a Multisite Randomized Controlled Trial to evaluate the advantages and disadvantages of two approaches for quitting smoking among people with serious mental illness (SMI). The study will compare a novel app tailored to people with SMI, Quit on the Go, to a standard of care smoking cessation intervention. We will test the effectiveness of the Quit on the Go app, an intervention that has demonstrated feasibility and acceptability in the target population, as a tool for smoking cessation in people with SMI. Participants with SMI will be recruited across 2 sites (Duke University and Univ. at Buffalo).
Detailed Description
Smoking tobacco shortens the lifespan of adults with serious mental illness by 25 years and contributes to 317 billion dollar expenditures in healthcare, indirect loss of earnings and disability benefits. Determining whether it is possible to deliver more effective and wider reaching smoking cessation interventions to individuals with serious mental illness is a high priority. Smartphone apps are a wide-reaching technology that could provide individuals with serious mental illness the necessary skills for quitting. However, our research has shown that apps developed for the general public have inadequate levels usability and engagement in people with serious mental illness. In a previous pilot trial of a tailored smoking cessation app for people with serious mental illness, Learn to Quit (NCT03069482), we identified successful recruitment and retention methods for smokers with SMI, demonstrated a 4-fold increase in objectively measured interactions of the novel app, obtained promising cessation rates for the experimental app (12% for Quit on the Go formerly "Learn to Quit" versus 3% for NCI QuitGuide), and identified a reliable methodological approach to conduct a fully-powered randomized controlled trial. Based on this pilot work, we plan to conduct a clinical trial to test this new model in a diverse and representative sample of the SMI population. Specifically, the proposed trial will test whether a tailored smoking cessation app for people with serious mental illness, Quit on the Go, results in higher levels of smoking abstinence compared to a standard of care intervention for this psychiatric population, Brief Advice. Both interventions will receive combined nicotine replacement therapy. The second aim of this trial is to test a mechanistic model of app efficacy by examining mediators of app engagement and treatment outcomes. Finally, the trial will evaluate the cost-effectiveness of these interventions to inform public health policy regard the use of mHealth in this population. In a multi-site, two-arm randomized controlled trial, 450 individuals with serious mental illness will be randomly assigned to one of two conditions. In the experimental condition, participants will use the Quit on the Go app. In the comparator condition, participants will receive Brief Advice for smoking cessation. Participants in both conditions will receive combined Nicotine Replacement Therapy (standard dosing of nicotine patch plus 5 week course of nicotine gums). Study duration will be 6 months, with 3 follow-up appointments at 1-month, 3-month, and 6-months. Our proposed methods are appropriate given our established procedures during our pilot trial regard to participant assignment, delivery of interventions, data collection and analysis (NCT03069482). The proposed study meets NIDA's major programmatic priorities of using innovative technologies (e.g., smartphones) and integrating behavioral and pharmacological interventions to improve substance use treatment and outcomes (NOT-DA-10-019). The proposal addresses a serious problem -- high smoking rates in people with SMI -- in a high priority, high cost population, by delivering a novel behavioral intervention for smoking cessation in "real-world" settings. If shown to be effective, the proposed intervention will provide a new model for delivering inexpensive, widely accessible smoking cessation interventions in adults with SMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Mental Illness, Recurring Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Persistent Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Quit on the Go" (formerly "Learn to Quit")
Arm Type
Experimental
Arm Description
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms. This app intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum). Participants also receive technical smartphone coaching for the first 4 weeks of the study.
Arm Title
Brief Advice (Standard of Care)
Arm Type
Other
Arm Description
Brief Advice and Combined Nicotine Replacement Therapy (patches and gum or lozenges) has been recommended by the US Clinical Practice Guidelines for patients with psychiatric illness. Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt. The intervention is combined with an 8-week course of nicotine replacement therapy (NRT) patches and a 5-10 week course of NRT gum (or Nicotine Lozenges if unable to use gum).
Intervention Type
Device
Intervention Name(s)
Quit on the Go App (formerly "Learn to Quit " App)
Intervention Description
A smartphone app developed by the research team designed for people with serious mental illness, that provides Acceptance and Commitment Therapy skills to address (a) smoking cessation and (b) mental health symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Brief advice
Intervention Description
Brief Advice will consist of 20 minutes of guidance about the use of nicotine replacement therapy, and strategies to initiate and maintain a quit attempt.
Intervention Type
Drug
Intervention Name(s)
Nicotine patch
Other Intervention Name(s)
NRT
Intervention Description
All participants will receive an 8-week course of transdermal nicotine patches. The first 4 weeks of use will be 21mg/24 hours, followed by 2 weeks of 14mg/24 hours patches, and finally 2 weeks of 7mg/24 hours patches.
Intervention Type
Behavioral
Intervention Name(s)
Smartphone coaching
Intervention Description
Participants randomized to the smartphone app intervention will receive 4 weeks of smartphone coaching given by research staff. The coaching is meant to be a time to address any issues that may rise with the participants' study smartphone or app.
Intervention Type
Drug
Intervention Name(s)
Nicotine gum
Other Intervention Name(s)
NRT
Intervention Description
Each participant enrolled will be given NRT gum (5-10week course) to be taken orally as nicotine cravings arise. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) gum pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Intervention Type
Drug
Intervention Name(s)
Nicotine Lozenges
Other Intervention Name(s)
NRT
Intervention Description
In cases where participants are unable to chew nicotine gum, lozenges will be sent as a replacement of Nicotine gum. Depending on participants' nicotine dependence, they will receive either the 2mg or 4mg (if they smoke within the first 30 minutes of waking) lozenge pieces per package instructions. We will direct subjects to use them for the first weeks following their quit date, using no more than one every 1-2 hours.
Primary Outcome Measure Information:
Title
CO-verified 7-day point-prevalence abstinence at 6-month follow-up
Description
Abstinence is determined by a self-report of not smoking any tobacco product for greater than or equal to 7 days prior to Week 24 and biochemically verified by an expired carbon monoxide breath test reading of < 5 ppm at Week 24. If the participant does not meet both criteria, they are not considered abstinent. As per convention, participants are assumed to be smoking if they report smoking at the time-point, cannot be reached to provide data at the time-point, fail to provide a breath sample at the time-point, or provide a breath sample at the time-point that is greater than or equal to 5 ppm.
Time Frame
6 month follow-up
Secondary Outcome Measure Information:
Title
Change in average number of cigarettes smoked per day
Description
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Time Frame
1 month follow-up
Title
Change in average number of cigarettes smoked per day
Description
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Time Frame
3 month follow-up
Title
Change in average number of cigarettes smoked per day
Description
Change in self-reported number of cigarettes smoked per day, averaged within groups.
Time Frame
6 month follow-up
Title
Average number of quit attempts per group
Description
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Time Frame
1 month follow-up
Title
Average number of quit attempts per group
Description
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Time Frame
3 month follow-up
Title
Average number of quit attempts per group
Description
Average number of quit attempts self-reported per group at the specified time point. Quit attempts are defined by no smoking at all for 24 hours or more.
Time Frame
6 month follow-up
Title
Time to 7-day relapse
Description
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
Time Frame
1 month follow-up
Title
Time to 7-day relapse
Description
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
Time Frame
3 month follow-up
Title
Time to 7-day relapse
Description
Average number of days of abstinence before relapse per group. Relapse defined by an instance of 7 consecutive days of smoking.
Time Frame
6 month follow-up
Title
30-day point prevalence abstinence rates
Description
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the timepoint.
Time Frame
1 month follow-up
Title
Biochemically confirmed 30-day point prevalence abstinence rates
Description
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the time point. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time Frame
3 month follow-up
Title
Biochemically confirmed 30-day point prevalence abstinence rates
Description
Percent of subjects in each group self-reporting no smoking at all for greater or equal to 30 days but < 30 days prior to the time point. Abstinence is determined by a self-report of not smoking any tobacco product at all during the corresponding time frame period, AND by a result of less than 5 ppm in carbon monoxide breath testing. If the participant does not meet both criteria, they are not considered abstinent.
Time Frame
6 month follow-up
Title
Prolonged abstinence rates
Description
Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period.
Time Frame
1 month follow-up
Title
Prolonged abstinence rates
Description
Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period.
Time Frame
3 month follow-up
Title
Prolonged abstinence rates
Description
Percent of subjects in each group reporting prolonged abstinence. Abstinence is determined by a self-report of not relapsing after their quit date (i.e., not smoking for 7 consecutive days, or not smoking at least once each week for 2 consecutive weeks) following a 2-week grace period.
Time Frame
6 month follow-up
Title
Continuous abstinence rates
Description
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point.
Time Frame
1 month follow-up
Title
Continuous abstinence rates
Description
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. Biochemically verified (CO < 5 ppm).
Time Frame
3 month follow-up
Title
Continuous abstinence rates
Description
Percent of subjects in each group self-reporting continuous abstinence (no smoking at all) between target quit date and specified time point. Biochemically verified (CO < 5 ppm).
Time Frame
6 month follow-up
Other Pre-specified Outcome Measures:
Title
Average app usability scores
Description
Average self-reported scores of usability on the 10-item System Usability Scale. Scores range from 0-100 with higher scores indicating higher usability of the app.
Time Frame
1 month follow-up
Title
Average user experience scores
Description
Average self-reported scores of user experience using an adapted 5-item app user experience scale.
Time Frame
1 month follow-up
Title
Average user experience scores
Description
Average self-reported scores of user experience using an adapted 5-item app user experience scale.
Time Frame
3 month follow-up
Title
Average user experience scores
Description
Average self-reported scores of user experience using an adapted 5-item app user experience scale.
Time Frame
6 month follow-up
Title
Average frequency of app use
Description
Average frequency of app use over the 24-week study period. Measured by average number of app openings.
Time Frame
Weeks 0-24
Title
Average duration of app use
Description
Average duration of app use over the 24-week study period.
Time Frame
Weeks 0-24
Title
Average number of app modules completed
Description
Average number of app modules completed over the 24-week study period.
Time Frame
Weeks 0-24
Title
Average acceptance of physical smoking cravings
Description
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
Time Frame
1 month follow-up
Title
Average acceptance of physical smoking cravings
Description
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
Time Frame
3 month follow-up
Title
Average acceptance of physical smoking cravings
Description
Average self-reported scores of acceptance of cravings on the physical sensations subscale of the Avoidance and Inflexibility Scale. Scores range from 4-20 with lower scores indicating more acceptance of smoking cravings.
Time Frame
6 month follow-up
Title
Nicotine patch use
Description
Average number of days (out of 56 possible) per arm that participants used the nicotine patch.
Time Frame
3 month follow-up
Title
Nicotine gum use
Description
Average number of nicotine gum used per arm.
Time Frame
3 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar, recurring major depressive disorder or Persistent Depressive Disorder Functional impairment as indicated by a score of_2 or greater on the WHODAS 8 item version Smoker as indicated by smoking greater than or equal to 5 cigarettes per day over the past 6 months; Desire to quit smoking as indicated by self-reported serious intention to quitting tobacco within the next 6 months; Age 18 and older; Willing and medically eligible to use NRT; Currently receiving psychiatric treatment and intent to receive treatment for the duration of the study (therapy, medications, etc.). Exclusion Criteria Problematic substance use, as defined by the Addiction Severity Index, within the last 30 days, twice within the past 6 months, or hospitalization for substance abuse within the past year. Current acute psychotic episode or unsafe to participate in the study as defined by the Mini International Neuropsychiatric Interview for Psychotic Disorders (Sheehan et al., 1998); Being pregnant or the intention to become pregnant in the next 6 months; Currently receiving any pharmacological and/or behavioral intervention or counseling for smoking cessation; Currently using e-cigarettes or other tobacco products besides cigarettes > 10 days in the past 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roger Vilardaga, PhD
Phone
9196813441
Email
roger.vilardaga@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Caitlyn Smith
Phone
9843774306
Email
caitlyn.smith@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Vilardaga, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Vilardaga, PhD
Phone
919-681-3441
Email
roger.vilardaga@duke.edu
First Name & Middle Initial & Last Name & Degree
Caitlyn Smith
Phone
984-377-4306
Email
caitlyn.smith@duke.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

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