An interventional study of Wearable Device-Based Monitoring and LE8 Feedback and Routine Outpatient Care With Data-Blinded Wearable Monitoring in Chronic Coronary Syndrome, sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Supportive care
The goal of this randomized controlled study is to evaluate whether a wearable device-based, Life's Essential 8 (LE8)-guided management strategy can improve cardiovascular health in patients with chronic coronary syndrome (CCS).
Approximately 400 participants will be randomly assigned in a 1:1 ratio to either a wearable device-based management group or a data-blinded control group. All participants will receive routine cardiology outpatient follow-up every 3 months for 12 months. Participants in the intervention group will be able to view selected smartwatch data and will receive health and medication reminders as well as individualized LE8 feedback. Participants in the control group will also wear the smartwatch for data collection, but the monitoring data, reminders, and LE8 feedback will not be made available to participants in the control group.
The main question is whether the wearable device-based management strategy results in a greater improvement in the overall LE8 cardiovascular health score from baseline to 12 months compared with routine outpatient management.
The OPPO-WATCH study is a single-center, prospective, randomized controlled superiority trial designed to evaluate a wearable device-based cardiovascular health management strategy in adults with chronic coronary syndrome (CCS). The study will enroll approximately 400 participants aged 18 years or older who meet the eligibility criteria and have a baseline Life's Essential 8 (LE8) cardiovascular health score of less than 80.
Before randomization, potentially eligible participants will undergo a 4-week run-in period using a data-blinded smartwatch to obtain baseline data required for LE8 assessment and to evaluate device-wearing adherence. Eligible participants will then be randomly assigned in a 1:1 ratio to the intervention group or control group using stratified block randomization. Randomization is stratified by sex, age, and the number of uncontrolled baseline cardiovascular risk factors.
Participants in the intervention group will have access to selected smartwatch-derived information, including physical activity and sleep data. The accompanying App will collect information on nicotine exposure, diet, and medication use. The system will provide reminders related to physical activity, sedentary behavior, sleep, smoking, diet, and medication use. After outpatient follow-up visits, available wearable data, questionnaire responses, clinical measurements, and laboratory data will be integrated to generate an individualized LE8 cardiovascular health report for the participant.
Participants in the control group will also wear the smartwatch, but the device will be used for data collection without providing monitoring data, health reminders, or LE8 feedback to the participant. Both groups will receive routine cardiology outpatient care, with visits at 3, 6, 9, and 12 months. Follow-up physicians will remain blinded to wearable monitoring data and LE8 reports and will make clinical decisions based on routine clinical information.
The primary outcome is the between-group difference in the change in overall LE8 cardiovascular health score from baseline to 12 months. Secondary and exploratory assessments include individual LE8 component scores, cardiovascular events, heart-rate-related measures, arrhythmia and heart rate variability parameters, medication adherence, quality of life, depressive symptoms, behavioral changes, system usability, and health care resource utilization.
2,866 studies on the registry are indexed under Coronary Disease; 308 are open to participants now.
This study's planned enrollment of 400 is above the median of 124 across 1,601 interventional studies indexed under Coronary Disease.
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Exclusion Criteria
Clinically significant severe arrhythmias, including but not limited to:
Participants receive wearable device-based, LE8-guided management with access to their monitoring data, health and medication reminders, and individualized LE8 score feedback, together with routine in-person cardiology outpatient follow-up every three months for 12 months.
Device: Wearable Device-Based Monitoring and LE8 Feedback
Participants wear a smartwatch for data collection but do not have access to monitoring data, health or medication reminders, or Life's Essential 8 (LE8) score feedback. They receive routine in-person cardiology outpatient follow-up every three months for 12 months.
Other: Routine Outpatient Care With Data-Blinded Wearable Monitoring
The smartwatch displays monitoring information, including physical activity and sleep data, and continuously uploads collected data to the study platform through encrypted transmission. The accompanying app collects questionnaires on smoking, diet, and medication use, which are verified during follow-up visits. The system provides reminders related to insufficient physical activity, prolonged sedentary time, insufficient sleep, smoking cessation or reduction, diet, and medication use. After each in-person follow-up visit, the system integrates wearable data, questionnaire responses, and clinical measurements to generate an LE8 cardiovascular health score report for the participant, with individualized prompts for components that do not meet target levels. Follow-up physicians remain masked to wearable monitoring data and LE8 reports and provide clinical care and medication adjustments based on routine clinical information.
The smartwatch displays only the time while collecting physical activity and sleep data. Monitoring data are not accessible to participants or follow-up physicians. The accompanying app collects questionnaires on smoking, diet, and medication use, which are verified during follow-up visits. The system does not provide health or medication reminders, scores, or feedback to participants. Collected data are encrypted and uploaded to a blinded backend for outcome assessment and quality control. LE8 scores are calculated automatically and exported for endpoint analysis after follow-up is completed. During routine in-person visits, physicians assess participants using clinical interviews, physical examinations, and necessary ancillary tests, and adjust medications and follow-up management without access to wearable monitoring data or LE8 scores.
Change in Life's Essential 8 (LE8) Cardiovascular Health Score
The primary outcome is the between-group difference in the change in the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score from baseline to 12 months. The LE8 score is calculated automatically by the cloud-based system using data on eight cardiovascular health components: physical activity, sleep health, nicotine exposure, diet, blood pressure, blood glucose, blood lipids, and body mass index. Each component is scored from 0 to 100, and the overall LE8 score is calculated as the unweighted average of the eight component scores, ranging from 0 to 100. Higher scores indicate better cardiovascular health.
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Blood Lipids Component Score
The Life's Essential 8 (LE8) Blood Lipids component score is calculated based on non-high-density lipoprotein cholesterol (non-HDL-C), defined as total cholesterol minus high-density lipoprotein cholesterol (HDL-C), according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood lipids domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Blood Glucose Component Score
The Life's Essential 8 (LE8) Blood Glucose component score is calculated based on blood glucose-related measurements according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood glucose domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Blood Pressure Component Score
The Life's Essential 8 (LE8) Blood Pressure component score is calculated based on measured systolic and diastolic blood pressure according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood pressure domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Body Mass Index Component Score
The Life's Essential 8 (LE8) Body Mass Index component score is calculated based on body mass index (BMI), derived from measured height and weight, according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the body mass index domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Physical Activity Component Score
The Life's Essential 8 (LE8) Physical Activity component score is calculated based on moderate-to-vigorous physical activity (MVPA), measured using the wearable device according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the physical activity domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Sleep Duration Component Score
The Life's Essential 8 (LE8) Sleep Duration component score is calculated based on sleep duration measured using the wearable device according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the sleep domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Nicotine Exposure Component Score
The Life's Essential 8 (LE8) Nicotine Exposure component score is calculated based on nicotine exposure assessed using a standardized questionnaire administered through the mobile application according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the nicotine exposure domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Diet Component Score
The Life's Essential 8 (LE8) Diet component score is calculated based on dietary information collected using a standardized questionnaire administered through the mobile application according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the dietary domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Time frame: From baseline through 12 months
LE8 Score ≥80 points
Proportion of participants with a Life's Essential 8 (LE8) cardiovascular health score ≥80 points at 12 months. The LE8 score ranges from 0 to 100, with higher scores indicating better cardiovascular health.
Time frame: 12 months
Proportion of Participants With an Increase of ≥5 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 5 points. The proportion of participants meeting this criterion will be calculated.
Time frame: Baseline to 12 months
Proportion of Participants With an Increase of ≥10 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 10 points. The proportion of participants meeting this criterion will be calculated.
Time frame: Baseline to 12 months
Proportion of Participants With an Increase of ≥15 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 15 points. The proportion of participants meeting this criterion will be calculated.
Time frame: Baseline to 12 months
Major Adverse Cardiovascular Events (MACE)
The incidence of the composite endpoint of MACE, including cardiac death, acute myocardial infarction, hospitalization for heart failure, and coronary revascularization.
Time frame: From baseline through 12 months
Cardiac death
The incidence of cardiac death.
Time frame: From baseline through 12 months
Acute myocardial infarction
The incidence of acute myocardial infarction.
Time frame: From baseline through 12 months
Hospitalization for heart failure
The incidence of hospitalization for heart failure.
Time frame: From baseline through 12 months
Coronary revascularization
The incidence of coronary revascularization.
Time frame: From baseline through 12 months
Incidence of New-onset Diabetes Mellitus
The incidence of newly diagnosed diabetes mellitus during the 12-month follow-up period among participants without diabetes at baseline. New-onset diabetes will be identified based on clinical diagnosis and/or standard diagnostic criteria, including HbA1c ≥6.5%, fasting plasma glucose ≥7.0 mmol/L, or 2-hour plasma glucose ≥11.1 mmol/L during an oral glucose tolerance test. In the absence of unequivocal hyperglycemia, confirmatory testing is required. The incidence will be compared between the two study groups.
Time frame: From baseline through 12 months
Incidence of New-onset Hypertension
The incidence of newly diagnosed hypertension during the 12-month follow-up period among participants without hypertension at baseline. New-onset hypertension will be identified based on a documented clinical diagnosis or repeated office blood pressure measurements showing systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, with confirmation according to applicable clinical guidelines. The incidence will be compared between the two study groups.
Time frame: From baseline through 12 months
Daytime Average Heart Rate
Changes in mean heart rate during waking hours (daytime) recorded by 24-hour Holter monitoring. Smartwatch data will be used as a reference for consistency assessment.
Time frame: Baseline and 12 months
Nighttime Average Heart Rate
Changes in mean heart rate during sleeping hours (nighttime) recorded by 24-hour Holter monitoring. Smartwatch data will be used as a reference for consistency assessment.
Time frame: Baseline and 12 months
24-hour Average Heart Rate
Changes in mean heart rate over the full 24-hour period recorded by Holter monitoring. Smartwatch data will be used as a reference for consistency assessment.
Time frame: Baseline and 12 months
Proportion of Participants Achieving Target Resting Heart Rate at 12 Months
Resting heart rate is defined as the 1-minute heart rate measured after at least 5 minutes of continuous rest without apparent physical activity. Resting heart rate will be primarily assessed using 24-hour Holter monitoring performed within 1 week before the 12-month visit. Under investigator supervision in a quiet hospital setting, the start and end of the resting period will be recorded, and the mean of three consecutive 1-minute heart rate measurements obtained after 5 minutes of rest will be used. Target resting heart rate is defined as 55-65 beats per minute. The proportion of participants achieving the target range at 12 months will be compared between the two study groups.
Time frame: 12 months
Heart Rate Deceleration Capacity (DC)
Change in heart rate deceleration capacity (DC) from baseline to 12 months, calculated from 24-hour Holter recordings to assess autonomic regulatory function. Changes will be compared between study groups.
Time frame: Baseline and 12 months
Heart Rate Acceleration Capacity (AC)
Change in heart rate acceleration capacity (AC) from baseline to 12 months, calculated from 24-hour Holter recordings to assess autonomic regulatory function. Changes will be compared between study groups.
Time frame: Baseline and 12 months
Arrhythmia and Electrophysiological Parameters
Changes in arrhythmia and electrophysiological parameters assessed by 24-hour Holter monitoring, including premature ventricular contractions (PVCs), PVC burden, non-sustained ventricular tachycardia (NSVT), significant bradycardia, pauses \>2 seconds, second-degree or higher atrioventricular block.
Time frame: Baseline and 12 months
Incidence of New-onset Atrial Fibrillation
New-onset AF is defined as the absence of AF evidence on baseline 12-lead ECG and 24-hour Holter, followed by the documentation of an AF episode lasting ≥30 seconds via ECG or Holter during the follow-up period.
Time frame: 12 months
Atrial Fibrillation Burden
The percentage of time in atrial fibrillation relative to the total recording time (%) derived from 24-hour Holter monitoring. Assessed at baseline and 12 months.
Time frame: Baseline and 12 months
Low-Density Lipoprotein Cholesterol (LDL-C)
Changes in LDL-C levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Time frame: Baseline and 12 months
Glycated Hemoglobin (HbA1c)
Changes in HbA1c levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Time frame: Baseline and 12 months
Fasting Blood Glucose (FBG)
Changes in FBG levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Time frame: Baseline and 12 months
Uric Acid (UA)
Changes in UA levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Time frame: Baseline and 12 months
Homocysteine (HCY)
Changes in plasma homocysteine levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Time frame: Baseline and 12 months
Changes in Cardiovascular Medication Use
Changes in cardiovascular medication use, including guideline-directed therapies such as antiplatelet agents, lipid-lowering medications, β-blockers, and renin-angiotensin system inhibitors, will be assessed from baseline to 12 months. Changes in the use of each medication class will be compared between the two study groups.
Time frame: 12 months
Medication Adherence
Change in medication adherence from baseline to 12 months, assessed using the Adherence to Refills and Medications Scale (ARMS).
Time frame: Baseline and 12 months
Change in EQ-5D-5L Index Value
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire assesses health in five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response levels, ranging from no problems to extreme problems or inability to perform. Responses across the five dimensions define a health state, which is represented by an EQ-5D-5L index value.
Time frame: Baseline and 12 months
Change in EQ Visual Analogue Scale (EQ VAS) Score
The EuroQol Visual Analogue Scale (EQ VAS) is a self-rated measure of overall health status. Scores range from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better perceived health status. The change in EQ VAS score from baseline to 12 months and the between-group difference in score changes will be assessed.
Time frame: Baseline and 12 months
Patient Health Questionnaire-9 (PHQ-9) Score
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report questionnaire assessing depressive symptoms over the preceding 2 weeks. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher total scores indicate more severe depressive symptoms and a worse outcome. The change in PHQ-9 total score from baseline to 12 months and the between-group difference in score changes will be assessed.
Time frame: Baseline and 12 months
Blood Pressure Control Rate
The proportion of participants achieving the target blood pressure control (\<130/80 mmHg) at 12 months.
Time frame: 12 months
Change in Peripheral Oxygen Saturation (SpO₂)
Change in peripheral oxygen saturation (percentage points) from baseline to 12 months.
Time frame: Baseline and 12 months
Difference in Estimated Life Expectancy
Difference in estimated life expectancy (years) between the two groups, derived from the observed difference in Life's Essential 8 (LE8) scores at 12 months using a prespecified life-expectancy estimation model.
Time frame: 12 months
Heart Rate Variability (HRV) Parameters
Exploratory changes from baseline to 12 months in time-domain heart rate variability parameters, including SDNN, SDANN, RMSSD, and pNN50, derived from 24-hour Holter recordings. Changes will be compared between the two study groups. Continuous smartwatch-derived heart rate data will be used as supplementary information.
Time frame: Baseline and 12 months
Proportion of Participants With Clinically Significant Depressive Symptoms (PHQ-9 Score ≥10)
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report questionnaire with a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. A total score of 10 or higher will be used to identify participants with clinically significant depressive symptoms. The proportion of participants with a PHQ-9 total score of 10 or higher at 12 months will be compared between the intervention and control groups. A positive screening result does not establish a clinical diagnosis of major depressive disorder.
Time frame: 12 months
Average Daily Steps
Pre-specified exploratory outcome. The average number of steps taken per day, continuously recorded by smartwatches throughout the study period.
Time frame: From baseline through 12 months
Daily Sedentary Time
Pre-specified exploratory outcome. The average duration of sedentary behavior per day, continuously recorded by smartwatches throughout the study period.
Time frame: From baseline through 12 months
Weekly Aerobic Exercise Time
Pre-specified exploratory outcome. The total duration of aerobic exercise accumulated per week, continuously recorded by smartwatches throughout the study period
Time frame: From baseline through 12 months
Average Daily Caloric Expenditure
Pre-specified exploratory outcome. The average energy expenditure (calories) per day, continuously recorded by smartwatches throughout the study period.
Time frame: From baseline through 12 months
Average Daily Wear Time
Pre-specified exploratory outcome. The average duration of smartwatch wear time per day, used to assess participant adherence to the device protocol.
Time frame: From baseline through 12 months
Data Availability (Successful Acquisition Rate)
Pre-specified exploratory outcome. The proportion of the study period with data successfully collected by the smartwatch, used to assess data availability.
Time frame: From baseline through 12 months
Magnitude of Heart Rate Reduction
Pre-specified exploratory outcome. The extent of reduction in heart rate from baseline levels, derived from continuous smartwatch monitoring.
Time frame: From baseline through 12 months
Heart Rate Variability/Fluctuation
Pre-specified exploratory outcome. The variability or fluctuation of heart rate over time, continuously recorded by smartwatches throughout the study period.
Time frame: From baseline through 12 months
Time to First Heart Rate Target Achievement
Pre-specified exploratory secondary outcome. The time elapsed from the start of the study to the first instance of achieving the predefined heart rate target.
Time frame: From baseline through 12 months
System Usability Scale (SUS) Score
Usability of the wearable device and accompanying digital health management system will be assessed in the experimental group using the System Usability Scale (SUS) at 12 months. The SUS score ranges from 0 to 100, with higher scores indicating better perceived usability. Results will be summarized descriptively without between-group comparison.
Time frame: 12 months
Number of Outpatient Visits
The total number of outpatient visits per participant from baseline through 12 months will be assessed using medical records and structured follow-up records. The outcome will be reported as the number of outpatient visits per participant and compared between the two study groups.
Time frame: From baseline through 12 months
Direct Medical Costs
Exploratory assessment of direct medical costs in both study groups, collected from baseline through 12 months in relation to healthcare resource utilization.
Time frame: From baseline through 12 months
Number of Emergency Department Visits
The total number of emergency department visits per participant from baseline through 12 months will be assessed using medical records and structured follow-up records. The outcome will be reported as the number of emergency department visits per participant and compared between the two study groups.
Time frame: From baseline through 12 months
Number of All-Cause Hospitalizations
The total number of all-cause hospital admissions per participant from baseline through 12 months will be assessed using hospitalization records and structured follow-up records. The outcome will be reported as the number of hospitalizations per participant and compared between the two study groups.
Time frame: From baseline through 12 months
Total Length of Hospital Stay
The cumulative length of hospital stay per participant from baseline through 12 months will be calculated by summing the duration of all hospitalizations, based on hospital admission and discharge records. The outcome will be reported in days per participant and compared between the two study groups.
Time frame: From baseline through 12 months
Number of Cardiovascular-Related Diagnostic Examinations
The total number of cardiovascular-related diagnostic examinations per participant from baseline through 12 months will be assessed using medical records and structured follow-up records. The outcome will be reported as the number of examinations per participant and compared between the two study groups.
Time frame: From baseline through 12 months
Incremental Cost-Effectiveness Ratio per Quality-Adjusted Life-Year Gained
The incremental cost-effectiveness ratio (ICER) of wearable device-based management compared with routine care will be evaluated over 12 months. The ICER will be calculated as the between-group difference in mean cumulative direct medical costs divided by the between-group difference in mean quality-adjusted life-years (QALYs) accrued during the 12-month follow-up period. QALYs will be estimated using health utility index values derived from the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire at baseline and 12 months. The outcome will be reported in Chinese yuan (CNY) per QALY gained.
Time frame: From baseline through 12 months
Incremental Cost-Effectiveness Ratio Based on Life's Essential 8 Score Improvement
The incremental cost-effectiveness ratio (ICER) of wearable device-based management compared with routine care will be evaluated over 12 months. The ICER will be calculated as the between-group difference in mean cumulative direct medical costs divided by the between-group difference in mean change in the Life's Essential 8 (LE8) cardiovascular health score from baseline to 12 months. The LE8 score ranges from 0 to 100, with higher scores indicating better cardiovascular health. The outcome will be reported in Chinese yuan (CNY) per additional 1-point improvement in LE8 score.
Time frame: From baseline through 12 months
Plan to share: Yes — Deidentified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers upon reasonable request and approval of a methodologically sound research proposal, subject to an appropriate data use agreement.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Beginning 36 months after publication of the primary study results and continuing for 5 years.
Access criteria: Deidentified individual participant data underlying the results reported in the primary publication will be available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the study investigators and, where applicable, relevant institutional or ethics authorities. Proposals that substantially overlap with prespecified ongoing analyses may be deferred until completion of those analyses. Data will be provided for the purposes specified in the approved proposal, subject to an appropriate data use agreement and applicable privacy and data protection requirements.
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