Moderate to Severe Atopic DermatitisCANDIDNCT06099704
Observational Study of Canadian Patients (6 Years or Older) Receiving Dupixent® for Moderate to Severe Atopic Dermatitis
An observational study of Moderate to Severe Atopic Dermatitis, run by Sanofi at 30 sites in Canada.
Trial summary
This is a prospective, 18-month observational study of adult, adolescent and pediatric Canadian participants with Atopic Dermatitis (AD) commonly known as Eczema, who receive treatment with Dupixent for moderate-to-severe AD (msAD) according to the Canadian-specific prescribing information (in accordance with the… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Moderate to Severe Atopic Dermatitis
- How many people
- 305 participants
- Where
- 30 sitesCanada
- Study dates
- 10 Oct 2023to 14 Apr 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Canadian msAD participants (ages 6+) who receive Dupixent for msAD according to the Canadian-country specific prescribing information (in accordance with the Canadian Dupixent Product Monograph)
Who may be able to join
- Male or female, 6 years or older at baseline visit (Canada has received the country's regulatory approval for use of Dupixent treating msAD for these ages).
- Participant is initiating dupilumab as part of routine clinical care through the Dupixent Patient Support Program (PSP) for the treatment of msAD, as per reimbursement criteria. Decision to treat with dupilumab must have been reached prior to and independently of recruitment in the study.
- Have a physician's diagnosis of msAD.
- Provided signed informed consent or parental/legally acceptable representative consent and/or participant assent. During the study, subjects will continue to receive maintenance therapies for their AD as clinically indicated and as per usual medical practice.
- Participant or Parental representative able to understand English and/or Canadian French to complete study-related questionnaires.
Who cannot join
- Participants who have a contraindication to the drug according to the Canadian-specific prescribing information label.
- Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the participant from adequately completing the schedule of visits and assessments.
- Participants currently participating in any interventional clinical trial which modifies participant care.
- Prior use of Dupixent within 6 months of the baseline visit.
- Participants not willing to sign the Informed Consent Form.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Canada30 sites
Investigational Site Number : 1240002
Ajax, Ontario, L1S 7K8
Investigational Site Number : 1240024
Barrie, Ontario, L4M 7G1
Investigational Site Number : 1240019
Calgary, Alberta, T2J 7E1
Investigational Site Number : 1240021
Calgary, Alberta, T3B 6A8
Investigational Site Number : 1240031
Cobourg, Ontario, K9A 0Z4
Investigational Site Number : 1240009
Edmonton, Alberta, T5J 3S9
Investigational Site Number : 1240007
Edmonton, Alberta, T5K 1X3
Investigational Site Number : 1240011
Etobicoke, Ontario, M8X 1Y9
Investigational Site Number : 1240026
Fredericton, New Brunswick, E3B 1G9
Investigational Site Number : 1240020
Halifax, Nova Scotia, B3H 4R2
Investigational Site Number : 1240016
London, Ontario, N6A 5R9
Investigational Site Number : 1240012
Montreal, Quebec, H3H 2R9
Investigational Site Number : 1240017
Montreal, Quebec, H3T 1C5
Investigational Site Number : 1240028
Nanaimo, British Columbia, V9V 1A3
Investigational Site Number : 1240025
Newmarket, Ontario, L3Y 5G8
Investigational Site Number : 1240008
Peterborough, Ontario, K9J5K2
Investigational Site Number : 1240006
Pointe-Claire, Quebec, H9R 5M7
Investigational Site Number : 1240013
Québec, G1W 4R4
Investigational Site Number : 1240003
Regina, Saskatchewan, S4V 1R9
Investigational Site Number : 1240005
Richmond Hill, Ontario, L4E 4L6
Investigational Site Number : 1240023
Saint-Jean-sur-Richelieu, Quebec, J3A 1B5
Investigational Site Number : 1240027
Saskatoon, Saskatchewan, S7K 2C1
Investigational Site Number : 1240010
Surrey, British Columbia, V3R 6A7
Investigational Site Number : 1240033
Toronto, Ontario, M3B 0A7
Investigational Site Number : 1240030
Toronto, Ontario, M4E 1R7
Investigational Site Number : 1240015
Toronto, Ontario, M5G 1E2
Investigational Site Number : 1240014
Toronto, Ontario, M5G 1X8
Investigational Site Number : 1240018
Waterloo, Ontario, N2J 1C4
Investigational Site Number : 1240034
Whitby, Ontario, L1N 8M7
Investigational Site Number : 1240029
Winnipeg, Manitoba, R3M 3Z4
About this study
Official title: A Prospective, Observational Study of Canadian Patients Receiving Dupixent® for Moderate to Severe Atopic Dermatitis
This is a prospective, 18-month observational study of adult, adolescent and pediatric Canadian participants with Atopic Dermatitis (AD) commonly known as Eczema, who receive treatment with Dupixent for moderate-to-severe AD (msAD) according to the Canadian-specific prescribing information (in accordance with the Canadian Dupixent Product Monograph). The study will be conducted in approximately 30 centers in Canada to assess participants of all ethnicities and races. At each participating site, all AD participants who receive an initial prescription for Dupixent will be invited to participate in this study, until the Canadian enrollment goal is achieved.
Read the detailed description
The duration of the study for each participant will be of 18 months.
- Conditions
- Moderate to Severe Atopic Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with msAD | Canadian msAD participants (ages 6+) who receive Dupixent for msAD according to the Canadian-country specific prescribing information (in accordance with the Canadian Dupixent Product Monograph) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants achieving a reduction in Eczema Area and Severity Index (EASI) of at least 75% at 6 months
EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics [erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.
Measured: Month 6
Percentage of participants achieving a reduction in EASI of at least 75% at 12 months
EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics [erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.
Measured: Month 12
Percentage of participants achieving a reduction in EASI of at least 75% at 18 months
EASI is a validated measure used to assess the severity and extent of AD. Four AD disease characteristics [erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition. Data will be assessed to understand real-world effectiveness of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD using EASI score.
Measured: Month 18
Secondary outcomes (35)
Change from baseline in EASI score
Four AD disease characteristics [erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification] will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scoresEASI is a composite index with scores ranging from 0-72. Higher scores indicate worse conditions. Data will be assessed to understand (1) the real-world effectiveness of of Dupixent in a heterogeneic population and (2) to characterize disease burden and unmet need in Canadian participants who initiate treatment for msAD.
Measured: From baseline to 6 months, 12 months, and 18 months post- Dupixent initiation
Change from baseline in Body Surface Area of Atopic Dermatitis Involvement (BSA) score
BSA affected by AD disease will be assessed for each major section of the body (head, neck, anterior trunk, back, upper limbs, lower limbs, and genitals). It will be reported as a percentage of all major body sections combined. Data will be assessed to understand (1) the real-world effectiveness of of Dupixent in a heterogeneic population and (2) to characterize disease burden and unmet need in Canadian participants who initiate treatment for msAD.
Measured: From baseline to 6 months, 12 months, and 18 months post- Dupixent initiation
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
HADS is a 14-item scale, with 7 items relating to anxiety and 7 relating to depression. Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. The total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher nxiety/depression complains. Data will be assessed to understand (1) the real-world effectiveness of of Dupixent in a heterogeneic population and (2) to characterize disease burden and unmet need in Canadian participants who initiate treatment for msAD.
Measured: From baseline to 6 months, 12 months, 18 months post-Dupixent initiation
Change from baseline in Skin pain/soreness numerical rating scale (NRS)
Skin pain NRS is a simple assessment tool asking participants to rate their skin pain or soreness using a 0 (No pain or soreness) to 10 (worst possible pain or soreness) NRS. Data will be assessed to understand (1) the real-world effectiveness of of Dupixent in a heterogeneic population and (2) to characterize disease burden and unmet need in Canadian participants who initiate treatment for msAD.
Measured: From baseline to 6 months, 12 months, 18 months post-Dupixent initiation
Change from baseline in skin feeling hot or burning NRS
Skin burning NRS is a simple assessment tool asking participants to rate the sensation of their skin feeling hot or burning sensation using a 0 (Not feeling hot at all) to 10 (feeling extremely hot) NRS. Data will be assessed to understand (1) the real-world effectiveness of of Dupixent in a heterogeneic population and (2) to characterize disease burden and unmet need in Canadian participants who initiate treatment for msAD.
Measured: From baseline to 6 months, 12 months, 18 months post-Dupixent initiation
Change from baseline in Peak Pruritus NRS (PP-NRS)
The peak pruritus NRS is a simple assessment tool asking participants to rate the intensity of their pruritis (itch) using a 0 (no itch) to 10 (worst possible itch) NRS. Data will be assessed to understand (1) the real-world effectiveness of of Dupixent in a heterogeneic population and (2) to characterize disease burden and unmet need in Canadian participants who initiate treatment for msAD.
Measured: From baseline to 6 months, 12 months, 18 months post-Dupixent initiation
Percentage of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs)
Measured: From baseline up to 18 months post-Dupixent initiation
Reasons for discontinuation of Dupixent therapy
Data will be assessed to understand the real-world safety of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD
Measured: From baseline up to 18 months post-Dupixent initiation
Mean time to Dupixent discontinuation
Data will be assessed to understand the real-world safety of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD
Measured: From baseline up to 18 months post-Dupixent initiation
Median time to Dupixent discontinuation
Data will be assessed to understand the real-world safety of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD
Measured: From baseline up to 18 months post-Dupixent initiation
Percentage of participants who initiated Dupixent and remained on treatment
Data will be assessed to understand the real-world safety of Dupixent in a heterogeneic population of Canadian participants who initiate treatment for msAD
Measured: At 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
Disease characteristics at baseline: EASI score
EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent. Four AD disease characteristics - erythema, thickness (induration, papulation, and edema), scratching (excoriation), and lichenification - will each be assessed for severity by the Investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage of each body area assessed: head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0 (0%), 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Total score is the sum of all subscores. EASI is a composite index with scores. Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent.
Measured: At baseline
Disease characteristics at baseline: BSA score
BSA affected by AD disease will be assessed for each major section of the body (head, neck, anterior trunk, back, upper limbs, lower limbs, and genitals). It will be reported as a percentage of all major body sections combined. Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent.
Measured: At baseline
Disease characteristics at baseline: Time between diagnosis and Dupixent prescription
Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent. Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent.
Measured: At baseline
Change from baseline in sleep Disturbance NRS scores post-Dupixent initiation
Participants will be asked to report the severity of their sleep disturbance during the past 7 days using a 0 (sleep not disturbed at all) to 10 (sleep extremely disturbed) NRS. Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent.
Measured: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
Change from baseline in the dermatology life quality index (DLQI)/the Children's Dermatology Life Quality Index (CDLQI) scores post-Dupixent initiation
The DLQI and CDLQI are a 10-item validated questionnaire to assess the impact of AD disease on quality of life (QoL) in adults and adolescents/pediatrics, respectively. The rating scale range from 0 (not at all) to 3 (very much) 10 items, which assess QoL over the past week. The total score is the sum of all 10-items ranging from 0 to 30; a high score is indicative of a poor QoL. The CDLQI will be used for adolescent participants (aged ≥ 12 to < 18 years) and pediatric participants (aged ≥ 6 to < 12 years); these participants will switch to the DLQI when they turn 18 years of age (if this happens during the study). The CDLQI will be completed with help from participant's caregivers. Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent.
Measured: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
Change from baseline in Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) scores post-Dupixent initiation
WPAI-AD is designed to assess the impact of AD disease on the participant's productivity. It is a 6-item validated questionnaire to measure effect of your AD disease on your ability to work and perform regular activities over a 7-day recall period. The questionnaire ask participants to recall following types of activities during the previous 7 days: absenteeism (time missed), presenteeism (impairment/ reduced effectiveness), productivity, and activity impairment. Total WPAI-AD outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Caregivers complete the questionnaire for affected children. Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent.
Measured: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
Change from baseline in Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) scores post-Dupixent initiation
WPAI-CIQ-AD is designed to asses the impact of AD disease on the participant's productivity. It is a 9-item validated questionnaire to measure participants ability to work, attend classes, and perform regular daily activities during the previous 7 days. Participants are asked to report the work time or classes lost due to AD disease; the impact of eczema on the performance in the workplace, at school, or during university classes; the effect of eczema on other daily activities during the previous 7 days. Total WPAI-AD outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Caregivers complete the questionnaire for affected children. Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent.
Measured: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
Change from baseline in Dermatitis Family Impact (DFI) score post-Dupixent initiation
DFI is a 10-question disease-specific measure to assess the impact of AD disease on the QoL of the parents and family members of affected children (≥ 6 to < 18 years)'. The DFI is calculated by summing the score of each question with a maximum total score of 30 (higher scores indicate higher impact on life of family). Caregivers complete the questionnaire for affected children. Data will be assessed to characterize disease burden and unmet need in Canadian msAD participants who initiate treatment with Dupixent.
Measured: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
Concomitant treatments received
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Dupixent dosing regimen
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Most commonly used Dupixent dosing regimens
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Dupixent treatment duration
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Number of gaps in Dupixent treatment
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Longest gap in Dupixent treatment
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Number of missed Dupixent doses over 18 months per participant
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
AD treatments to which participants switch when discontinuing dupixent
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Reasons for initiation of new AD treatments
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Reasons for discontinuation and/or switching AD treatments
Data will be assessed to describe real-world treatment patterns in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline up to 18 months
Change from baseline in HADS
HADS is a 14-item scale, with 7 items relating to anxiety and 7 relating to depression. Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. The total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher nxiety/depression complains. Data will be assessed to understand patterns and/or changes in non-atopic conditions in Canadian msAD participants who initiate treatment with Dupixen.
Measured: From baseline to 6 months, 12 months and 18 months post- Dupixent initiation
Change from baseline in sleep disturbance NRS scores post-Dupixent initiation
Participants will be asked to report the severity of their sleep disturbance during the past 7 days using a 0 (sleep not disturbed at all) to 10 (sleep extremely disturbed) NRS. Data will be assessed to understand patterns and/or changes in non-atopic conditions in Canadian msAD participants who initiate treatment with Dupixent.
Measured: From baseline to 3 months, 6 months, 12 months and 18 months post- Dupixent initiation
Change from baseline in height
Data will be assessed to understand patterns and/or changes in non-atopic conditions in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline to 6 months, 12 months and 18 months post- Dupixent initiation
Change from baseline in weight
Data will be assessed to understand patterns and/or changes in non-atopic conditions in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline to 6 months, 12 months and 18 months post- Dupixent initiation
Change from baseline in BMI
Data will be assessed to understand patterns and/or changes in non-atopic conditions in Canadian msAD participants who initiate treatment with Dupixent
Measured: From baseline to 6 months, 12 months and 18 months post- Dupixent initiation
Number of participants with demographic characteristics
Data will be assessed for all demographic characteristics by age, sex, race and ethnicity, location to understand baseline characteristics and/or changes in Canadian msAD participants who initiate treatment with Dupixent, with co-existing type 2 inflammatory diseases.
Measured: From baseline up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start10 Oct 2023
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099704
- Sponsor's protocol ID
- OBS17843
- Other IDs
- U1111-1288-8240
- Acronym
- CANDID
- Status last verified
- May 2026
- First submitted
- 10 Oct 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org