Health Systems Reach Interventions Project

NCT04199117 | Completed Phase 4 Results DMC FDA Drug

• 7 other identifiers: 2019-09392P01CA180945-06A534253SMPH/MEDICINE/MEDICINE*G5736UW20070Protocol Version 10/25/2023
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

This project seeks to identify ways to enhance the reach of evidence-based smoking cessation treatments among adult primary care patients who smoke daily and are not ready to start treatment at study enrollment. The 2x2x2x2 factorial experiment will evaluate the extent to which 4 intervention components promote the use of evidence-based treatments to help smokers not initially ready to quit to cease smoking over 2 years. The intervention components tested include: modest financial incentives for completing an initial counseling session in a smoking cessation treatment (vs. none); automated semi-annual outreach materials sent via patients' preferred communication modality using data in the electronic health record to tailor and personalize invitations to use available treatments to quit smoking (vs. untailored letters); direct, proactive telephone outreach from a tobacco care manager who will promote treatment use and deliver motivational intervention twice per year (vs. none); and access to 3 no-cost telephone smoking cessation counseling calls with combination nicotine replacement therapy (C-NRT) or varenicline (vs. state tobacco quitline and primary care provider referral). Proactive treatment offers will be made up to 22 months after enrollment. Smoking status and use of any smoking cessation treatments will be assessed every 6 months through 2 years of study enrollment. Data from 1664 adult primary care patients meeting inclusion/exclusion criteria will be analyzed to see whether the intervention components have an effect on the use of treatment (primary outcome) and smoking status after 2 years of treatment access (secondary outcome). The project will evaluate the manipulated intervention components first in terms of treatment initiation (defined as rates of completing at least 1 smoking cessation counseling session prior to a target stop-smoking date), and then in terms of end-of-study (2 year post-enrollment) abstinence rates (secondary outcome), and cost-effectiveness in promoting reach (tertiary outcome). This experiment will help to identify health system reach interventions that effectively enhance utilization of stop smoking treatments in an effort to help more smokers quit and to prevent tobacco-induced cancer morbidity and mortality.

Conditions

Smoking, Cigarette; Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Initiate Treatment Over 1 Year of Study Enrollment

  The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over 1-year of study enrollment period, vs. 0=no evidence of treatment initiation).

  1 year

• Number of Participants Who Initiate Treatment Over 2 Years of Study Enrollment

  The operational definition of treatment initiation is completing at least 1 session of psychosocial treatment in an available smoking cessation treatment. The primary coding of this outcome will be binary (1=any treatment initiation, as defined above, over the 2-year study enrollment period, vs. 0=no evidence of treatment initiation).

  2 years

Secondary Outcomes (1)

• Number of Participants Who Achieve Biochemically Verified Seven-day Point Prevalence Abstinence 2 Years Post-enrollment

  2 years from enrollment

Other Outcomes (4)

• First Year Intervention Costs From Healthcare and Societal Perspectives

  1 year

• Second Year Intervention Costs From Healthcare and Societal Perspectives

  2 years

• Number of Participants Who Complete Intensive Treatment

  2 years

Study Arms (16)

Incentive,Tailored,Care Manage,Intensive Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Monetary incentives for initiating treatment; Behavioral: Automated tailored outreach; Behavioral: Care management; Behavioral: Multiple smoking cessation coaching calls

Incentive,Tailored,Care Manage,Standard Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Behavioral: Monetary incentives for initiating treatment; Behavioral: Automated tailored outreach; Behavioral: Care management; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral

Incentive,Tailored,No Care Manage,Intensive Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Monetary incentives for initiating treatment; Behavioral: Automated tailored outreach; Behavioral: Multiple smoking cessation coaching calls

Incentive,Tailored,No Care Manage,Standard Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Behavioral: Monetary incentives for initiating treatment; Behavioral: Automated tailored outreach; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral

Incentive,Untailored,Care Manage,Intensive Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Monetary incentives for initiating treatment; Behavioral: Care management; Behavioral: Untailored outreach; Behavioral: Multiple smoking cessation coaching calls

Incentive,Untailored,Care Manage,Standard Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Behavioral: Monetary incentives for initiating treatment; Behavioral: Care management; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral; Behavioral: Untailored outreach

Incentive,Untailored,No Care Manage,Intensive Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Monetary incentives for initiating treatment; Behavioral: Untailored outreach; Behavioral: Multiple smoking cessation coaching calls

Incentive,Untailored,No Care Manage,Standard Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have access to incentives for completing a first smoking cessation counseling call up to 4 times over 2 years, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Behavioral: Monetary incentives for initiating treatment; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral; Behavioral: Untailored outreach

No Incentive,Tailored,Care Manage,Intensive Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will have not access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Automated tailored outreach; Behavioral: Care management; Behavioral: Multiple smoking cessation coaching calls

No Incentive,Tailored,Care Manage,Standard Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Behavioral: Automated tailored outreach; Behavioral: Care management; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral

No Incentive,Tailored,No Care Manage,Intensive Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Automated tailored outreach; Behavioral: Multiple smoking cessation coaching calls

No Incentive,Tailored,No Care Manage,Standard Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 tailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Behavioral: Automated tailored outreach; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral

No Incentive,Untailored,Care Manage,Intensive Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Care management; Behavioral: Untailored outreach; Behavioral: Multiple smoking cessation coaching calls

No Incentive,Untailored,Care Manage,Standard Treatment

EXPERIMENTAL

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will receive 5 Tobacco Care Management support and motivational encouragement calls over 2 years, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Behavioral: Care management; Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral; Behavioral: Untailored outreach

No Incentive,Untailored,No Care Manage,IntensiveTreatment

EXPERIMENTAL

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not Tobacco Care Management support and motivational encouragement calls, and will have access to 3 smoking cessation quit counseling calls and 12-weeks of either combination nicotine replacement or varenicline up to 4 times over 2 years.

Drug: Varenicline; Drug: Combination nicotine patch and nicotine mini-lozenge treatment; Behavioral: Untailored outreach; Behavioral: Multiple smoking cessation coaching calls

No Incentive,Untailored,No Care Manage,Standard Treatment

ACTIVE COMPARATOR

Participants randomly assigned to this condition will not have access to incentives for completing smoking cessation counseling, will receive 5 untailored letters promoting use of smoking cessation treatment over 2 years, will not receive Tobacco Care Management support and motivational encouragement calls, and will have access to standard smoking cessation treatment (referral to the state tobacco quitline and/or their primary care provider) over 2 years.

Other: Wisconsin Tobacco Quit Line referral; Other: Primary care provider referral; Behavioral: Untailored outreach

Interventions

Varenicline DRUG

Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.

Incentive,Tailored,Care Manage,Intensive Treatment; Incentive,Tailored,No Care Manage,Intensive Treatment; Incentive,Untailored,Care Manage,Intensive Treatment; Incentive,Untailored,No Care Manage,Intensive Treatment; No Incentive,Tailored,Care Manage,Intensive Treatment; No Incentive,Tailored,No Care Manage,Intensive Treatment; No Incentive,Untailored,Care Manage,Intensive Treatment; No Incentive,Untailored,No Care Manage,IntensiveTreatment

Combination nicotine patch and nicotine mini-lozenge treatment DRUG

Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.

Incentive,Tailored,Care Manage,Intensive Treatment; Incentive,Tailored,No Care Manage,Intensive Treatment; Incentive,Untailored,Care Manage,Intensive Treatment; Incentive,Untailored,No Care Manage,Intensive Treatment; No Incentive,Tailored,Care Manage,Intensive Treatment; No Incentive,Tailored,No Care Manage,Intensive Treatment; No Incentive,Untailored,Care Manage,Intensive Treatment; No Incentive,Untailored,No Care Manage,IntensiveTreatment

Monetary incentives for initiating treatment BEHAVIORAL

Participants randomized to this intervention will earn an incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.

Incentive,Tailored,Care Manage,Intensive Treatment; Incentive,Tailored,Care Manage,Standard Treatment; Incentive,Tailored,No Care Manage,Intensive Treatment; Incentive,Tailored,No Care Manage,Standard Treatment; Incentive,Untailored,Care Manage,Intensive Treatment; Incentive,Untailored,Care Manage,Standard Treatment; Incentive,Untailored,No Care Manage,Intensive Treatment; Incentive,Untailored,No Care Manage,Standard Treatment

Automated tailored outreach BEHAVIORAL

Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.

Incentive,Tailored,Care Manage,Intensive Treatment; Incentive,Tailored,Care Manage,Standard Treatment; Incentive,Tailored,No Care Manage,Intensive Treatment; Incentive,Tailored,No Care Manage,Standard Treatment; No Incentive,Tailored,Care Manage,Intensive Treatment; No Incentive,Tailored,Care Manage,Standard Treatment; No Incentive,Tailored,No Care Manage,Intensive Treatment; No Incentive,Tailored,No Care Manage,Standard Treatment

Care management BEHAVIORAL

Participants randomized to this intervention will receive 5 live, proactive phone calls lasting 10-15 minutes from as assigned Tobacco Care Manager who will provide manualized support and motivational encouragement, discuss available treatment options, and inform the participant how to initiate treatment when ready to quit.

Incentive,Tailored,Care Manage,Intensive Treatment; Incentive,Tailored,Care Manage,Standard Treatment; Incentive,Untailored,Care Manage,Intensive Treatment; Incentive,Untailored,Care Manage,Standard Treatment; No Incentive,Tailored,Care Manage,Intensive Treatment; No Incentive,Tailored,Care Manage,Standard Treatment; No Incentive,Untailored,Care Manage,Intensive Treatment; No Incentive,Untailored,Care Manage,Standard Treatment

Wisconsin Tobacco Quit Line referral OTHER

This is recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. The Wisconsin Tobacco Quit Line (WTQL) offers a single 20-minute counseling session to all Wisconsin residents ready to set a date to stop smoking in the next month, at no charge, and offers those who meet their medical eligibility criteria a 2-week supply of either nicotine patches, lozenges, or gums, at no charge. The WTQL assumes full clinical responsibility for participants' use of cessation medications dispensed by the WTQL.

Incentive,Tailored,Care Manage,Standard Treatment; Incentive,Tailored,No Care Manage,Standard Treatment; Incentive,Untailored,Care Manage,Standard Treatment; Incentive,Untailored,No Care Manage,Standard Treatment; No Incentive,Tailored,Care Manage,Standard Treatment; No Incentive,Tailored,No Care Manage,Standard Treatment; No Incentive,Untailored,Care Manage,Standard Treatment; No Incentive,Untailored,No Care Manage,Standard Treatment

Primary care provider referral OTHER

This is a form of recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. Participants who choose to use this intervention will be referred electronically to their primary care provider for counseling and/or medication if they express an interest in quitting in the next 30 days and agree to this referral.

Incentive,Tailored,Care Manage,Standard Treatment; Incentive,Tailored,No Care Manage,Standard Treatment; Incentive,Untailored,Care Manage,Standard Treatment; Incentive,Untailored,No Care Manage,Standard Treatment; No Incentive,Tailored,Care Manage,Standard Treatment; No Incentive,Tailored,No Care Manage,Standard Treatment; No Incentive,Untailored,Care Manage,Standard Treatment; No Incentive,Untailored,No Care Manage,Standard Treatment

Untailored outreach BEHAVIORAL

Participants randomized to this intervention will receive 5 untailored letters delivered every 4-6 months. Letter content will not be tailored or personalized. Letters will offer information about how to access available treatments.

Incentive,Untailored,Care Manage,Intensive Treatment; Incentive,Untailored,Care Manage,Standard Treatment; Incentive,Untailored,No Care Manage,Intensive Treatment; Incentive,Untailored,No Care Manage,Standard Treatment; No Incentive,Untailored,Care Manage,Intensive Treatment; No Incentive,Untailored,Care Manage,Standard Treatment; No Incentive,Untailored,No Care Manage,IntensiveTreatment; No Incentive,Untailored,No Care Manage,Standard Treatment

Multiple smoking cessation coaching calls BEHAVIORAL

Participants randomized to intensive treatment access who choose to quit will receive three 15-20-minute quit coaching calls from a trained smoking cessation health counselor. Calls will be scheduled for one week pre-quit, one day after the target quit day, and one week after the target quit day.

Incentive,Tailored,Care Manage,Intensive Treatment; Incentive,Tailored,No Care Manage,Intensive Treatment; Incentive,Untailored,Care Manage,Intensive Treatment; Incentive,Untailored,No Care Manage,Intensive Treatment; No Incentive,Tailored,Care Manage,Intensive Treatment; No Incentive,Tailored,No Care Manage,Intensive Treatment; No Incentive,Untailored,Care Manage,Intensive Treatment; No Incentive,Untailored,No Care Manage,IntensiveTreatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary care patient who receives care at one of the host family medicine or internal medicine clinics
• \>17 years old
• Report smoking 7 of the last 7 days at enrollment
• Report smoking at least five cigarettes per day for at least 6 months at enrollment
• Able to speak and read English

You may not qualify if:

• Opted out of Care Manager outreach at the most recent clinic visit or by phone
• Willing to quit smoking within 30 days (these patients will be referred for immediate treatment rather than enrolled in this study)
• Inability to use both C-NRT and varenicline due to a contraindication to both treatments at enrollment (allergic reactions, severe renal disease)
• Current treatment for schizophrenia or a psychotic disorder at enrollment
• History of suicide attempt in the past 10 years at enrollment

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UW Center for Tobacco Research and Intervention

Madison, Wisconsin, 53711, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Limitations and Caveats

The target sample size to provide sufficient statistical power to detect hypothesized effects was N=1664. The trial was closed to recruitment after randomizing 210 participants because the recruitment model was not working as intended. We converted this trial into a pilot study and launched a new study that used clinic-level random assignment to evaluate different strategies to promote the reach of evidence-based tobacco treatment among adult primary care patients.

Results Point of Contact

• Title: Danielle McCarthy, Ph.D.
• Organization: University of Wisconsin School of Medicine and Public Health

demccarthy@ctri.wisc.edu

6082655949

Study Officials

• Michael C Fiore, MD,MPH,MBA

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors collecting follow-up data on quit attempts, use of treatment, and smoking status will be blind to experimental condition.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 x 2 x 2 x 2 factorial experiment

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: March 11, 2020
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after publication of primary outcome paper
• Access Criteria: Prior written request to the PI.

Locations

US (1)