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Trial registered on ANZCTR


Registration number
ACTRN12620001075976
Ethics application status
Approved
Date submitted
25/06/2020
Date registered
19/10/2020
Date last updated
11/08/2024
Date data sharing statement initially provided
19/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A pragmatic trial seeking to implement an improved model of care for people with either insomnia or obstructive sleep apnoea (OSA) within an Australian primary care setting, in order to increase access to evidence-based therapies
Scientific title
A cluster-randomised controlled implementation trial of a new, evidence-based model of care for chronic insomnia and obstructive sleep apnoea in Australian primary care.
Secondary ID [1] 301531 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Insomnia 317893 0
Obstructive sleep apnea (OSA) 317894 0
Condition category
Condition code
Respiratory 315930 315930 0 0
Sleep apnoea
Mental Health 315931 315931 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Design: Cluster-randomised controlled pragmatic implementation trial
SLEEP HEALTH PACKAGES to guide the management of chronic insomnia and obstructive sleep apnea (OSA) in Primary Care (PC) will be provided to participating intervention-arm clinics:
A. EDUCATION & CLINICAL PRACTICE GUIDELINES (CPGs)
(1) Education for GPs and Practice Nurses (PNs): Approximately 6 hours (2-hours on chronic insomnia and 4-hours on sleep apnoea) (GPs/PNs) and 1-week of in-service training (PNs). The ~6-hour course will be delivered in-person to groups of PC-clinicians by a Specialist Sleep Physician (SSP), a Specialist Sleep Nurse (SSN), and a Specialist Sleep Psychologist. This education will have a similar format to that of our team’s RCT comparing OSA management in a PC versus specialist setting (Chai-Coetzer et al. 2013 JAMA), and consists of educational lectures and a hands-on workshop where clinicians learn more about diagnostic tests and treatments for OSA and insomnia. We will discuss and provide attendees with a copy of our PC CPGs. In-service training will be led by a SSN, take place in a sleep clinic setting and will incorporate CPAP set-up and follow-up.

(2) Online CPGs: User-friendly PC guidelines.
These CPGs have been developed by a senior academic/clinical GP and have been edited by our multi-disciplinary National Centre for Sleep Health Services Research team. The purpose is to provide a user-friendly, PC-specific guide to insomnia and OSA for clinicians, which complements our online education modules and in-person training.

(3) (Optional) Online education modules will be made available: Developed/updated in conjunction with the Royal Australian College of General Practitioners (RACGP) and Australasian Sleep Association.
Our 2 RACGP gpLearning Modules (Insomnia and OSA Management in General Practice) are self-administered education modules, designed to provide general practitioners (GPs) with evidence-based information on the identification, diagnosis, management, and follow-up of patients with insomnia and OSA in a PC-setting. Each module takes about 1 hour to complete. The insomnia module includes 'slides' with information and diagrams, multiple-choice questions, and short-answer questions about the definitions, diagnosis, management, and a case scenario about insomnia management. The OSA module covers: OSA definition, differentiation between simple snoring and OSA, economic cost of sleep disorders in Australia, prevalence, pathophysiology, risk factors, consequences of OSA, assessment, treatment and referral options.

B. SCREENING & POINT-OF-CARE TESTING
Eligibility will require: Chronic Insomnia, diagnosed via Sleep Condition Indicator questionnaire or high-risk of symptomatic moderate-severe OSA, diagnosed using a combination of questionnaires (OSA50 and Epworth Sleepiness Scale i.e. ESS).

C) TREATMENT & ACCESS/REFERRAL PATHWAYS.
Those diagnosed with chronic insomnia and/or OSA will be offered the treatment options described below, with specific strategies to monitor adherence.

INSOMNIA:
GP/PN brief CBTi: We provide training for PNs in this brief behavioural intervention as part of our 1-week education program. Brief CBTi is a manualized intervention delivered over 4 weeks, which can be delivered during a combination of in-person and phone/tele-health appointments. The first session is 45 minutes, and the follow-up sessions are approximately 30-45 minutes. Adherence to brief CBTi will be defined as the number of sessions completed. Briefly, the topics covered are: basic information about insomnia, the processes which control sleep (sleep drive and circadian processes), an overview of insomnia (prevalence, characteristics, symptoms), and healthy sleep hygiene behaviours. This information is important to ensure the patient understands the rationale for the behavioural therapies (bedtime restriction therapy and stimulus control therapy) which are introduced and adjusted over the subsequent 3 sessions.

Online CBTi: Sleepio is a leading digital sleep-improvement program, based on CBTi techniques. Sleepio’s core program consists of 6 weekly sessions in which a virtual sleep expert talks the participant through personalised techniques. Each session lasts about 20 minutes, and is tailored to progress and problems. Between sessions, participants complete a Sleep Diary to track progress and are sent reminders to aid adherence. Throughout, participants are supported by a community of other users, 10 online tools and a library of over 100 articles. Adherence will be defined as the number of sessions completed. PNs will contact patients approximately 3 weeks after referral for Sleepio, to check on program commencement and offer motivational advice to continue with CBTi recommendations.

CBTi from a Specialist Sleep Psychologist: This is current best practice for insomnia management but remains underutilised. GPs may refer patients to existing local sleep psychologists. Our specialist centre has psychologists who will provide this service in-person/via telemedicine. The service will consist of a 6-week individually tailored program. Adherence will be defined as the number of sessions attended. During CBTi, a patient is provided with information to ensure that they understand the rationale for the main component of this therapy, bedtime restriction therapy, which aims to modify the bedtime routine/behaviours over several weeks to gradually increase sleep pressure/drive in the evening, promote more rapid sleep onset, reduce the duration of nocturnal awakenings, and reduce the conditioned relationship between the bedroom/bedtime routine and an insomnia response. Therapy is personalised based on self-reported nightly sleep patterns and bedtime routine over the past 1-2 weeks and often begins by reducing the amount of time spent in bed to match perceived sleep duration, then maintaining this routine over the next 1-2 weeks. After sleep becomes more consolidated, time spent in bed is gradually extended until a comfortable equilibrium between sleep time, time in bed, and sleepiness is achieved.

Participant flow: After insomnia is confirmed, the participant will be offered brief CBTi or online CBTi. If a poor response is noted at the GP follow-up (within 1 month), they will be offered referral to a psychologist.

OSA:
(1) Patients with a high-risk of symptomatic, moderate-severe OSA based on the OSA50 and ESS questionnaires will be referred for a single-night at-home ApneaLink sleep study to confirm OSA. Patients with no/mild OSA (3% Oxygen desaturation index <16) will receive ongoing management but will not be eligible for CPAP therapy. Patients with moderate or severe OSA (oxygen desaturation index =>16) will be eligible for CPAP therapy.
Participants with mild and moderate-severe OSA will be provided lifestyle advice via written information (e.g. weight loss, minimise alcohol intake, avoid sedative-hypnotics, supine avoidance, good sleep hygiene, etc.).
(2) Continuous Positive Airways Pressure (CPAP): Healthcare card holders and pension card holders will be offered nurse-delivered CPAP equipment, setup and review appointments in the general practice clinic. Non-healthcare/pension card holders will receive initial determination of required CPAP pressure in the general practice setting and will be referred to private CPAP clinics for CPAP setup and ongoing management. The initial visit will take one hour. In that session, the patient will receive information about why CPAP is needed, how it works, mask fitting, CPAP safety and side effects and how to operate and maintain equipment, then invite the participant to return at 2 weeks. For most participants, follow-up will be undertaken at three-monthly intervals thereafter. CPAP adherence will be defined as average nightly use of CPAP. Patients with private health insurance will be reimbursed $600 toward their purchase of CPAP. This is to reflect average private rebate for CPAP therapy from private insurers.
(3) Mandibular Advancement Splints (MAS): MAS devices (and equivalent) move the lower jaw forward during sleep to increase the pharyngeal airway space and prevent collapse of the pharynx, and are effective for most patients. A list of preferred providers will be given to GPs. Adherence to these devices will be measured via self-report of nightly use.
(4) Referral to a SSP: Eligible patients who refuse treatment or have treatment failure in the trial are recommended for referral to SSP. Treatment/adherence monitoring will be in accordance with usual SSP protocols.
Participant flow: After moderate-severe OSA is confirmed on the ApneaLink study, participants will be offered CPAP therapy and lifestyle advice. If CPAP is refused, ineffective or poorly tolerated, then referral to a dentist for a MAS will be recommended. If MAS is refused, ineffective or poorly tolerated, referral to a SSP will be recommended. Patients can be referred at any time as required at the discretion of the GP.
A total 6-month follow-up is planned.
Practices, GPs, PNs, Practice Managers, and patients will be reimbursed for trial-related activities, including attendance at educational programs, throughout the trial that are in addition to usual care.
Intervention patients will be reimbursed $20 per questionnaire completed, and $20 for (optional) qualitative interviews (~$80).
Intervention code [1] 317860 0
Treatment: Other
Comparator / control treatment
The control arm will have 'Treatment as Usual (TAU)' i.e. usual clinical intervention for the 6-month duration of the study. The TAU group clinicians will not receive any specific training or interventional materials and will be asked to continue with their usual management of sleep disorders. Patients with sleep disorders (suspected OSA and chronic insomnia) will still be invited to participate in the data collection process (i.e. sleep disorder screening and completion of self-report questionnaires). After completion of the trial, the TAU sites will be provided access to intervention education, and interventions for patients recruited into the trial including; Sleepio, streamlined access to ‘sleep’ psychologists at the Adelaide Institute for Sleep Health specialist insomnia program, and patients with OSA that are awaiting review at the Southern Adelaide Local health Network Sleep Service will receive facilitated access to sleep physicians and funded CPAP equipment if eligible ((i.e. confirmed moderate-severe OSA and possess a Health Care Card or Pensioner Concession Card).

Patients at control sites will be reimbursed $20 per questionnaire battery completed ($60 total during trial).
Control group
Active

Outcomes
Primary outcome [1] 324176 0
A non-inferiority margin of 2 points difference in the mean change in Epworth Sleepiness Scale (ESS) at 6 months compared to baseline.
Timepoint [1] 324176 0
6-month period post patient recruitment
Primary outcome [2] 324177 0
Insomnia: Change in patient-recorded/reported use of sedative-hypnotic medication (nights per week for the last 2 weeks) at the 6-month follow up relative to baseline use for the model of care compared to TAU. Commonly used pharmacological agents for insomnia, which include benzodiazepines (BZDs; e.g. temazepam, oxazepam, nitrazepam), non-BZD hypnotics (‘z-drugs’; e.g. zopiclone, zolpidem), and antidepressants/antipsychotics (e.g. trazodone, amitriptyline, mirtazapine, quetiapine). We will also collect data on melatonin and other sleeping pill.
Timepoint [2] 324177 0
6-month period post patient recruitment
Primary outcome [3] 331685 0
Between-group difference in Sleep Condition Indicator Questionnaire: 8-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria
Timepoint [3] 331685 0
6-months after participant recruitment
Secondary outcome [1] 383919 0
Sleep Condition Indicator Questionnaire: 8-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria.
Timepoint [1] 383919 0
Baseline, 3 months, and 6 months
Secondary outcome [2] 383921 0
Generalised Anxiety Disorder-7: 7 item scale for anxiety symptoms.
Timepoint [2] 383921 0
Baseline, 3 months, and 6 months
Secondary outcome [3] 383922 0
Patient Health Questionnaire-9: 9-item scale for diagnosing and evaluating depression.
Timepoint [3] 383922 0
Baseline, 3 months, and 6 months
Secondary outcome [4] 383923 0
Epworth Sleepiness Scale: Respondents rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in 8 activities.
Timepoint [4] 383923 0
Baseline, 3 months, and 6 months
Secondary outcome [5] 383925 0
Assessment of Quality of Life-4D (AQoL-4D): 12-item measure of health-related quality of life, which specifically asks about sleep disturbances, and can be used for cost-utility studies.
Timepoint [5] 383925 0
Baseline, 3 months, and 6 months
Secondary outcome [6] 383926 0
Use of Hospital and Primary Health Care Services: Healthcare utilisation measure developed by AESOPS Trial team. 13-items, recording healthcare use in the last 6 months.
Timepoint [6] 383926 0
Baseline, 3 months, and 6 months
Secondary outcome [7] 383927 0
Patient satisfaction visual analogue scale
Timepoint [7] 383927 0
Baseline, 3 months, and 6 months
Secondary outcome [8] 383928 0
Case identification rate: We will measure the proportion of patients attending GP appointments who are identified to have a sleep disorder in the intervention period compared with the treatment as usual period using electronic practice records.
Timepoint [8] 383928 0
Entire intervention period (i.e. from baseline to 6-months post-intervention commencement).
Secondary outcome [9] 383929 0
Feasibility and acceptability (composite outcome) of the model of care will be assessed by conducting qualitative semi-structured interviews with participating GPs/PNs/practice managers/patients. This qualitative research will incorporate a variety of data collection methods, including audio-recorded semi-structured one-on-one telephone or face-to-face interviews (of 30 minutes duration), focus groups and observational research.
Timepoint [9] 383929 0
After study follow-up is completed.
Secondary outcome [10] 385582 0
Length of time for appointments will be collected in order to estimate the appropriate level of MBS funding to aid a future Medicare Advisory Service Committee (MSAC) application
Timepoint [10] 385582 0
After study follow-up is completed.
Secondary outcome [11] 385583 0
Cost-effectiveness

The cost-effectiveness of the intervention relative to TAU will be determined using a decision-analytic model. Within-trial incremental health-system costs will be estimated using MBS, pharmaceutical benefits scheme (PBS), and diagnosis-related group (DRG) data with patient private costs collected using a resource use questionnaire. Within-trial effectiveness will be modelled using the primary outcomes (for OSA and insomnia) and QALYs (estimated using patient responses to the AQoL-4D). To determine beyond-trial cost-effectiveness, a comprehensive systematic literature search will be carried out to identify longer-term published cost and utility data for the model. Costs associated with development and delivery of the intervention will be estimated using administrative data collected as part of the trial. The health economics analysis will include cost-effectiveness, acceptability, cost-savings, expected net loss curves to inform decision makers of the optimal strategy at any threshold for different subgroups and the uncertainty around this decision. We will also collect data on the length of time for appointments required in order to estimate the appropriate level of MBS funding to aid a future Medicare Advisory Service Committee (MSAC) application.
Timepoint [11] 385583 0
After study follow-up is completed.

Eligibility
Key inclusion criteria
General Practitioners: We will include GPs who are currently practising in Australia and give written informed consent.

Insomnia: To be eligible for inclusion, a potential participant with chronic insomnia must meet diagnostic criteria based on a Sleep Condition Indicator (SCI) questionnaire score of less than or equal to 16 (which has been shown to correctly identify 89% of patients with insomnia, and correctly exclude 82% of those without) and report insomnia symptoms for at least 3 months i.e. a higher SCI score indicates better sleep. The SCI scale has been reverse-coded on GP screening forms, to align with the other questionnaires (higher scores = worse symptoms/health).

Obstructive Sleep Apnea (OSA): To be eligible for inclusion, a potential participant must meet the following criteria:
• OSA-50 questionnaire score of greater than or equal to 5 (indicating high probability of moderate-severe OSA) AND Epworth sleepiness scale (ESS) score of greater than or equal to 8 (indicating at least mild symptoms of sleepiness).

Additional general eligibility criteria:
Inclusions: At least 18 years of age, able to provide informed consent and complete patient questionnaires, currently living in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General exclusion criteria: Drug/alcohol problems, terminal illness, unstable or poorly controlled psychiatric illness or significant cognitive impairment which would affect patient’s ability to understand or comply with study requirements, epilepsy or muscle spasms requiring benzodiazepine, women who are currently pregnant, limited English comprehension, no access to MBS-PBS (e.g. not Australian resident or citizen), or Department of Veterans Affairs card holder. Previous investigation for OSA in the past 10 years, with or without treatment (for patients being considered for the OSA pathway).

Condition specific exclusion criteria are then applied to potentially eligible patients to identify those with complex OSA or complex insomnia who are not suitable for simplified management in the primary care setting and should be treated as usual/referred for specialist care.

OSA treatment pathway exclusion criteria: BMI>=50 Kg/m2; Chronic opioid use; Hospitalisation in past 3 months for MI, unstable angina, cardiac failure, or CVA or New York Heart Association class III or IV symptoms; Neuromuscular disease; Lung disease & wake oxygen saturation <92%; Using supplemental oxygen; Confirmed/suspected sleep hypoventilation syndromes; Previous sleepiness-related motor-vehicle accident.

Insomnia treatment pathway exclusion criteria: Epworth Sleepiness Scale score of 16-24, average time in bed <6h; average perceived total sleep time <3h; Shift work (rotating, nights); Circadian rhythm disorder (evidence of advanced or delayed sleep wake phase disorder).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this cluster-randomised controlled trial, we will randomise 20 clinics, (10 into intervention and 10 into Treatment As Usual (TAU) arms). To detect our primary outcomes for OSA and insomnia, respectively, we will require 300 new cases of OSA, and 300 insomnia cases. Australian BEACH study data indicates that we are likely to exceed our targets, since in 12 months 20 GPs will likely encounter 2080 insomnia (~2 insomnia cases/week/GP) and 1560 OSA cases (~1.5 OSA cases/week/GP).

• OSA: The sample size for the OSA primary outcome 1- the Epworth Sleepiness Scale (ESS), was based on a non-inferiority test of two means for a parallel, two-group cluster-randomized design using PASS 2023, version 23.0.1. Assuming a non-inferiority margin of -2, 10 clusters per Group, 90% power and a Type I error rate (a) of 0.025, common subject-to-subject SD for both groups = 4, ICC=0.01, coefficient of variation of cluster sizes = 0.65 a total of 200 subject is required (10 subjects per cluster). Because patients are recruited who are at risk of having OSA with an elevated ESS, the number of subjects was increased (n=300) in order to recruit adequate numbers of moderate to severe patients with OSA (~half) to give practice nurses and GPs adequate experience in the diagnosis and management of OSA and account for 20% drop out rate over 12 months.

• INSOMNIA: Primary outcome 2, patient-recorded/reported use of sedative-hypnotic medication (nights per week, in the last 2 weeks, use of benzodiazepines, non-BZD hypnotics (‘z-drugs’; e.g. zopiclone, zolpidem), and antidepressants/antipsychotics (e.g. trazodone, amitriptyline, mirtazapine, quetiapine) at the 12-month follow up relative to baseline use for the model of care compared to TAU. The sample size was based on a test of two means for a parallel, two-group cluster-randomized design using Stata/SE, version 18.0. Assuming a reduction of 1.82, 10 clusters per Group, 80% power and a Type I error rate (a) of 0.05, common subject-to-subject SD for both groups = 4.9, ICC=0.01, a total of 260 subject is required (13 subjects per cluster). It is estimated that only 75% of the participants will be using sleeping medications and therefore the sample size was inflated accordingly to 300 participants in total (15 subjects per cluster) allowing for a 10-15% drop-out rate over 12 months.

In regard to primary outcome 3, the Sleep Condition Indicator outcome, the cluster size required to detect a conservative delta of 3 between TAU and PC is 9 individuals, Given a control-group mean of 14.97 and that both groups have 10 clusters and that the standard deviations of the two groups are both 5.93; assume a two-sided test with a 5% (alpha) significance level, a power of 90%, and an intraclass correlation of 0.01, and assume that both groups will have the same cluster size. Therefore, the total sample size is (9*10)*2=180. Assuming a drop out rate of 15%, then n=210 are required. The SCI outcome will be therefore adequately powered based on the sample size required for the sedative/hypnotic medication reduction outcome.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2022
Actual
5/05/2023
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
600
Accrual to date
115
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 305970 0
Commercial sector/Industry
Name [1] 305970 0
ResMed Support for Investigator-Initiated Research
Country [1] 305970 0
Australia
Funding source category [2] 305993 0
Commercial sector/Industry
Name [2] 305993 0
Philips Respironics Research
Country [2] 305993 0
United States of America
Funding source category [3] 310446 0
Government body
Name [3] 310446 0
National Health and Medical Research Council
Country [3] 310446 0
Australia
Funding source category [4] 310447 0
Charities/Societies/Foundations
Name [4] 310447 0
Royal Australian College of General Practitioners (RACGP)
Country [4] 310447 0
Australia
Funding source category [5] 310448 0
Charities/Societies/Foundations
Name [5] 310448 0
Country SA Primary Healthcare Network (PHN)
Country [5] 310448 0
Australia
Funding source category [6] 310449 0
Charities/Societies/Foundations
Name [6] 310449 0
Sleep Health Foundation
Country [6] 310449 0
Australia
Funding source category [7] 310450 0
Charities/Societies/Foundations
Name [7] 310450 0
Australasian Sleep Association
Country [7] 310450 0
Australia
Funding source category [8] 310451 0
Commercial sector/Industry
Name [8] 310451 0
Big Health
Country [8] 310451 0
United Kingdom
Funding source category [9] 310452 0
Government body
Name [9] 310452 0
Southern Adelaide Local Health Network
Country [9] 310452 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Health and Medical Research Institute: Sleep Health
5 Laffer drive, Bedford Park, SA, 5042
Country
Australia
Secondary sponsor category [1] 306454 0
None
Name [1] 306454 0
Address [1] 306454 0
Country [1] 306454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306210 0
Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC)
Ethics committee address [1] 306210 0
Ethics committee country [1] 306210 0
Australia
Date submitted for ethics approval [1] 306210 0
28/09/2020
Approval date [1] 306210 0
24/05/2021
Ethics approval number [1] 306210 0
Ethics committee name [2] 310086 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [2] 310086 0
Ethics committee country [2] 310086 0
Australia
Date submitted for ethics approval [2] 310086 0
16/08/2021
Approval date [2] 310086 0
08/09/2021
Ethics approval number [2] 310086 0
10/07/2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103106 0
Prof Robert Adams
Address 103106 0
Flinders Health and Medical Research Institute: Sleep Health
Flinders University
Sturt Road,
Bedford Park, SA, 5042
Country 103106 0
Australia
Phone 103106 0
+61874219751
Fax 103106 0
Email 103106 0
robert.adams@flinders.edu.au
Contact person for public queries
Name 103107 0
Andrew Vakulin
Address 103107 0
Flinders Health and Medical Research Institute: Sleep Health
Flinders University
Sturt Road,
Bedford Park, SA, 5042
Country 103107 0
Australia
Phone 103107 0
+61 872218308
Fax 103107 0
Email 103107 0
andrew.vakulin@flinders.edu.au
Contact person for scientific queries
Name 103108 0
Andrew Vakulin
Address 103108 0
Flinders Health and Medical Research Institute: Sleep Health
Flinders University
Sturt Road,
Bedford Park, SA, 5042
Country 103108 0
Australia
Phone 103108 0
+61872218308
Fax 103108 0
Email 103108 0
andrew.vakulin@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.