An interventional study of Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants and Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants in Hypertension, Dyslipidemia and Diabetes Mellitus, sponsored by University of Connecticut. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Connecticut · Not applicable, Interventional, and Health services research
The investigators will conduct a feasibility and pilot efficacy randomized controlled trial to test the usability and user satisfaction of an evidence-based digital health tool the investigators developed for clinicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 clinicians, including physicians, physician assistants, or advanced practice registered nurses, from two local hospitals in CT, USA. Clinicians will recruit two patients each (N=48) having CVD risk factors. Clinicians will deliver a P3-EX exercise prescription (ExRx) to one of their patients (n=24) and the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) ExRx to the other (n=24) in a random sequence crossover design. Clinicians and patients will rate the feasibility and acceptability of each method using validated questionnaires. Patients will perform their prescribed ExRx for 12 weeks and complete a self-report exercise diary to monitor exercise adherence with virtual oversight from University of Connecticut (UConn) Graduate Research Assistants. Before and after the exercise intervention, the investigators will measure patient CVD risk factors and physical activity (PA) levels via accelerometry. The primary aim is to evaluate the feasibility and acceptability of P3-EX for clinicians to use to prescribe exercise to patients with CVD risk factors, and the secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence. The investigators hypothesize P3-EX will be feasible for clinicians to use to prescribe customized exercise routines for patients with CVD risk factors, and clinicians and patients will be satisfied with P3-EX.
Background
Approximately half of U.S. adults have 1 or more of the major CVD risk factors of obesity, hypertension, dyslipidemia, and diabetes, and 1 in 4 have 3 or more. Professional organizations such as the American College of Sports Medicine (ACSM) and the American Heart Association (AHA) recommend exercise as a first-line lifestyle therapy to prevent and treat CVD and its risk factors. The ACSM advocates clinicians to assess PA as a vital sign and prescribe exercise for every patient. However, only about 20% of U.S. adults and 44-56% of patients with CVD risk factors report being advised by their health care providers to exercise. Although clinicians are receptive to prescribing exercise to their patients, they encounter barriers to doing so such as a lack of time, training, and the tools. Digital health tools show promise as clinical decision support systems to guide clinicians in prescribing exercise to their patients. The investigators developed a clinical decision support tool named P3-EX. P3-EX includes: 1) the ACSM exercise preparticipation health screening recommendations to determine if there is a need for medical clearance; 2) an adapted AHA Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk; 3) the ACSM strategies for designing an ExRx for adults with multiple CVD risk factors; and 4) the ACSM Frequency, Intensity, Time, Type (FITT) ExRx for the prioritized CVD risk factor posing the greatest risk.
Objectives
The primary aim of this trial is to evaluate the feasibility and acceptability of P3-EX for clinicians to use to prescribe exercise to patients with CVD risk factors.
The secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence.
Study Procedures
The investigators will recruit 24 clinicians, including physicians, physician assistants, or advanced practice registered nurses, from Hartford HealthCare or UConn Health clinics using email listservs, newsletters, university communication channels, flyers, and word of mouth. Clinicians will attend a virtual study orientation led by a UConn Graduate Research Assistant to provide informed consent, confirm eligibility, complete demographics, assess barriers to and confidence with ExRx, and receive brief ExRx delivery training to their patients. Clinicians will then recruit two of their patients (N=48) who have obesity, hypertension, dyslipidemia, and/or diabetes. Patients will attend two in-person study visits led by a UConn Graduate Research Assistant at a clinic in Hartford or Farmington, CT, to provide informed consent, confirm eligibility, complete demographics, and assess the AHA Life's Essential 8, anthropometrics, vitals, subjective PA levels via the Timeline Followback for Exercise, and objective PA levels via accelerometry. Patients will attend their local Quest Diagnostics Service Center to assess blood lipid-lipoproteins and blood glucose. Clinicians will be individually randomized with a 1:1 allocation ratio to deliver an P3-EX ExRx to one of their patients and the ACSM-PAVS ExRx to the other patient in a random sequence crossover design. Patients will attend their healthcare appointment with their clinicians and receive either a P3-EX ExRx (n=24) or the ACSM-PAVS ExRx (n=24). Within 48 hours following each healthcare appointment, clinicians and patients will complete the validated mHealth Application Usability Questionnaire and the System Usability Scale to rate the feasibility and acceptability of P3-EX or ACSM-PAVS. Patients will be asked to perform their ExRx and monitor their exercise adherence for 12 weeks using the Timeline Followback for Exercise with virtual oversight from UConn Graduate Research Assistants. Patients will receive a 12-week exercise program information packet, two exercise guidance virtual student visits led by UConn Graduate Research Assistants, and weekly progressive FITT exercise goals via email from UConn Graduate Research Assistants. UConn Graduate Research will also provide Timeline Followback for Exercise summary reports to patients weekly via email. At post-intervention, patients will attend two more in-person study visits led by a UConn Graduate Research Assistant at a clinic in Hartford or Farmington, CT to assess trial satisfaction, AHA Life's Essential 8, CVD risk factors and PA levels.
Statistical Analysis Plan
The investigators will conduct statistical analyses using Statistical Package for the Social Sciences Version 30. The investigators will first use descriptive statistics and graphical techniques to ensure all test assumptions are met, including the inspection for outliers, normal distributions, and homogeneity of variances. Missing values will be addressed using model-based approaches and/or multiple imputations when appropriate to include the entire randomized sample. If normality assumptions are not met for secondary outcomes, considerations will be made to transform the data to achieve a normal distribution or use alternative non-parametric approaches such as permutated tests. An alpha level of 0.05 will be used to determine statistical significance.
The investigators will use the following statistical approaches to evaluate the feasibility and acceptability of P3-EX for clinicians to use to prescribe exercise to patients with CVD risk factors. The investigators will use a one-sided Wilcoxon signed-rank test (one sample case) to assess whether the clinicians mHealth Application Usability Questionnaire ratings of P3-EX and the ACSM-PAVS are above the null hypothesis middle score of 4.0 on the Likert scale, and whether System Usability Scale ratings are above the average score of 68/100. The investigators will use a linear mixed effects model adjusting for the delivery order of P3-EX and PAVS and the time between delivery as potential covariates and interactions between these two covariates to assess differences in clinician usability questionnaire scores between P3-EX and the ACSM-PAVS. The investigators will use normal linear regression to test the strength of relationships between the three domains on the mHealth Application Usability Questionnaire and the usage time of P3-EX.
The investigators will use the following statistical approaches to explore the preliminary efficacy of P3-EX to improve patient PA levels, CVD risk factors, and exercise adherence. A one-way Analysis of Variance will test if pre-intervention values are equal between groups, indicating if there is a need to adjust for potential covariates related to demographics, medication use, and/or pre-intervention PA level and CVD risk factor values. The investigators will use a repeated measures two-way Analysis of Covariance using a linear mixed effects model to test patient differences in PA level and CVD risk factor changes over 12 weeks between the P3-EX and the ACSM-PAVS groups, adjusting for potential covariates related to demographics, medication use, and/or pre-intervention values.
Scientific Rationale
The novelty of P3-EX is supported by the investigators' systematic review which evaluated whether there are decision support tools on the market that utilize evidence-based ExRx standards of the ACSM and AHA to target CVD risk factors. The investigators evaluated 219 exercise apps that were rated ≥4 out of 5 overall with ≥1000 reviews, free to download, and not gender specific. Of the 219 apps, very few (0 to 4.3%) were evidence based, had a preparticipation screening protocol, framed exercise plans by the FITT of ExRx, specified special considerations, or focused on chronic diseases or health conditions, and only 28% built CVD risk factor profiles. The investigators concluded there are no evidence-based ExRx apps on the market like P3-EX.
The potential usability and user satisfaction of P3-EX in the healthcare setting is further supported by the investigators' feasibility survey study. A total of 309 healthcare providers and allied health professionals, including 101 physicians, completed a timed case study using the P3-EX web-based algorithm, and then rated its satisfaction and usability using the Mobile Application Rating Scale. Most of the respondents (93%) agreed they would recommend P3-EX to their colleagues, the primary goal of any feasibility study, and 80% agreed P3-EX produced safe ExRx and were satisfied with P3-EX. Also, over 70% agreed P3-EX would make their patients healthier and could save them time, prescribing exercise in an average time of 4.6 minutes.
Conclusions
This protocol provides the scientific rationale and methodology to test P3-EX within a real-world clinical setting, to inform the feasibility of using P3-EX as a digital health support tool to be used by clinicians to prescribe personalized FITT ExRx to their patients with CVD risk factors, and the preliminary efficacy of P3-EX to improve patient cardiovascular health and PA levels. If successful, this trial could demonstrate that P3-EX is a solution for clinicians to overcome their barriers to ExRx, which includes lacking the tools, training, time, and confidence. The investigators intend to use the pilot data for secondary outcomes to power a larger clinical trial to evaluate the efficacy of P3-EX for improving PA levels and CVD risk factors.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Connecticut is the lead sponsor of 135 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 16, 2026. See what changed
Clinician Inclusion Criteria
Patient Inclusion Criteria
≥1 cardiovascular disease risk factors: Having obesity, hypertension, dyslipidemia, and/or diabetes (or prediabetes)
Patient Exclusion Criteria 4a. Have pain or discomfort in the chest, neck, jaw, or arms; dizziness or syncope; shortness of breath at rest or with mild exertion; unusual fatigue or shortness of breath with usual activities; orthopnea; ankle edema; intermittent claudication; palpitations; or known heart murmur 4b. Stroke or cancer survivors or currently have cancer, , musculoskeletal injury, chronic back pain, depression, dementia, or other diseases or health conditions that are deemed to significantly limit physical activity engagement.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinicians will use Prioritizes Personalizes Prescribes Exercise (P3-EX), hosted by a web-based platform, to deliver P3-EX, an evidence-based personalized exercise prescription to improve cardiovascular disease (CVD) risk factors. P3-EX will determine whether the patient needs medical clearance. P3-EX will score the patient's CVD risk factors using an adapted American Heart Association Life's Essential 8 cardiovascular health scoring system to determine the CVD risk factor posing the greatest risk. If ≥2 CVD risk factors are tied for the greatest risk, P3-EX will prompt the clinician to choose an American College of Sports Medicine strategy to prioritize one CVD risk factor to personalize the Frequency, Intensity, Time, and Type (FITT) exercise prescription. P3-EX will also produce special exercise considerations for the prioritized CVD risk factor. The clinician will print the exercise prescription and give it to the patient to perform for 12 weeks.
Behavioral: Experimental - 12 Week P3-EX Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants
Clinicians will use a hard copy instruction manual adapted from the Exercise is Medicine HealthCare Providers' Action Guide to deliver the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), a generic exercise program to improve general health. The clinicians will ask the patient exercise preparticipation health screening questions to determine whether medical clearance is needed. The clinicians will assess their patient's physical activity levels as a vital sign (i.e., minutes per week of moderate to vigorous intensity exercise and days per week of resistance exercise). The clinician will give the patient the ACSM-PAVS exercise program as a handout, which recommends the Physical Activity Guidelines for Americans of 150 minutes per week of moderate and/or 75 minutes per week of vigorous intensity aerobic exercise (or a combination) and 2 days per week of muscular strengthening exercise.
Behavioral: Active Control - 12 Week ACSM-PAVS Unsupervised Exercise Program with Virtual Weekly Oversight from Graduate Research Assistants
UConn Graduate Research Assistants will provide patients with virtual weekly oversight to follow their P3-EX unsupervised exercise program for 12 weeks. Patients will choose the location and the FITT of exercise they prefer. UConn Graduate Research Assistants will provide all patients with a 12-week exercise program information packet containing progressive FITT exercise recommendations for their exercise program. Patients will use an exercise diary called the Timeline Followback for Exercise to record the FITT of exercise daily. Patients will attend two virtual study visits led by UConn Graduate Research Assistants during the first week and midway through the intervention to receive standardized guidance on how they are doing following their exercise program. UConn Graduate Research Assistants will email all patients weekly to provide their progressive FITT exercise recommendations and summary reports of their Timeline Followback for Exercise recordings.
University of Connecticut (UConn) Graduate Research Assistants will provide patients with virtual weekly oversight to follow their ACSM-PAVS unsupervised exercise program for 12 weeks. Patients will choose the location and the FITT of exercise they prefer. UConn Graduate Research Assistants will provide all patients with a 12-week exercise program information packet containing progressive FITT exercise recommendations for their exercise program. Patients will use an exercise diary called the Timeline Followback for Exercise to record the FITT of exercise daily. Patients will attend two virtual study visits led by UConn Graduate Research Assistants during the first week and midway through the intervention to receive standardized guidance. UConn Graduate Research Assistants will email all patients weekly to provide their progressive FITT exercise recommendations and summary reports of their Timeline Followback for Exercise recordings.
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
The mHealth Application Usability Questionnaire is validated to measure the usability of mobile health apps for healthcare providers and/or patients through 21 items spilt into three subscales; Ease of Use and Satisfaction, System Information Arrangement, and Usefulness. The rating of each item is scaled from 1 to 7, and responses are averaged to provide a single score. Clinicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be compared to the middle score of 4.0.
Time frame: Within 48 hours following the delivery of P3-EX and ACSM-PAVS
Feasibility and Acceptability of Prioritize Personalize Prescribe EXercise (P3-EX)
The System Usability Scale is the most common questionnaire to assess the usability of mHealth apps. Ratings for each of the 10 items are scaled from 1 to 5. Clinicians will rate both P3-EX and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), and patients will rate the one they receive. Overall scores (mean ± SD) will be scaled from 0 to 100 and compared to normative reference ratings and scores in the literature.
Time frame: Within 48 hours following the delivery of P3-EX and ACSM-PAVS
Clinician Barriers to and Confidence with Exercise Prescription (ExRx)
Clinicians will complete an adapted ExRx self-reflection questionnaire before completing brief ExRx training and within 48 hours following the delivery of either Prioritize Personalize Prescribe EXercise (P3-EX) or the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), to assess the impact of the trial on their perceived barriers to and confidence with ExRx. Responses will be rated a Likert scale from 1 to 4, with 4 being the highest impact from a barrier or the highest confidence with a skill (mean ± SD).
Time frame: Before completing brief ExRx training and within 48 hours following the delivery of either P3-EX or ACSM-PAVS
American Heart Association Life's Essential 8 Score Change from Baseline
Patient Cardiovascular Health Scores from 0 to 100 points will be determined at pre- and 12-weeks post-intervention (mean ± SD) based on patient survey responses to metrics of diet, PA, nicotine exposure, sleep health, and assessed values of body mass index, blood pressure, blood lipids, and blood glucose.
Time frame: 12 weeks
Resting Blood Pressure Changes
Patient resting systolic and diastolic blood pressure (mm Hg) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via automatic monitors (OMRON HEM-705CP, Kyoto, Japan), to indicate health improvement for hypertension.
Time frame: 12 weeks
Resting Heart Rate Changes
Resting heart rate (bpm) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via automatic monitors (Polar Electro Oy F7, Kempele, Finland, respectively), to indicate health improvement for cardiovascular fitness.
Time frame: 12 weeks
Body Mass Index Changes
Height (m) and weight (kg) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via a mechanical beam balance scale with stadiometer (Health o meter, Pelion, IL, USA) to calculate body mass index (kg/m2) and indicate health improvement for obesity.
Time frame: 12 weeks
Waist Circumference Changes
Patient waist circumference (cm) will be assessed at pre- and 12-weeks post-intervention (mean ± SD) via a Gullick tape measure (Sammons Preston) to indicate health improvement for obesity.
Time frame: 12 weeks
Blood Lipid-Lipoproteins Profile Changes
Patient total cholesterol, triglycerides, high-density lipoproteins, and low-density lipoproteins (mg/dL) will be assessed at pre- and 12 weeks post-intervention (mean ± SD), processed by phlebotomy technicians at Quest Patient Service Centers, to indicate health improvement for dyslipidemia.
Time frame: 12 weeks
Blood Glucose Profile Changes
Glycated hemoglobin (%) will be assessed at pre- and 12 weeks post-intervention (mean ± SD), processed by phlebotomy technicians at Quest Patient Service Centers, to indicate health improvement for diabetes.
Time frame: 12 weeks
Blood Glucose Profile Changes
Fasting plasma glucose (mg/dL) will be assessed at pre- and 12 weeks post-intervention (mean ± SD), processed by phlebotomy technicians at Quest Patient Service Centers, to indicate health improvement for diabetes.
Time frame: 12 weeks
Subjective Physical Activity Levels Changes
Patient self-reported physical activity levels will be assessed at pre-intervention and 12 weeks post-intervention via the Timeline Followback for Exercise for the various Frequency, Intensity, Time, and Type (FITT) metrics (mean ± SD). The Timeline Followback for Exercise is a validated calendar diary method for recording the FITT of exercise, whereby, frequency is the number of days per week that physical activity is performed; type is the modality of physical activity performed (e.g., running, weightlifting); time is the duration performed in minutes for each modality; and intensity using the Borg 6-20 rating of perceived exertion scale. Graduate Research Assistants will assign a metabolic equivalent (MET) value for each recorded exercise to calculate exercise volume in MET\*min/wk.
Time frame: Weekly for 12 weeks
Exercise Adherence
Patient self-reported physical activity levels will be assessed weekly for the 12-week exercise intervention via the Timeline Followback for Exercise for the various Frequency, Intensity, Time, and Type (FITT) metrics (mean ± SD). The Timeline Followback for Exercise is a validated calendar diary method for recording the FITT of exercise, whereby, frequency is the number of days per week that physical activity is performed; type is the modality of physical activity performed (e.g., running, weightlifting); time is the duration performed in minutes for each modality; and intensity using the Borg 6-20 rating of perceived exertion scale. Graduate Research Assistants will assign a metabolic equivalent (MET) value for each recorded exercise to calculate exercise volume in MET\*min/wk.
Time frame: Weekly for 12 weeks
Objective Physical Activity Level Changes
Minutes of physical activity per day within different intensities (i.e., light, moderate, and vigorous) will be measured at pre- and 12-weeks post-intervention (mean ± SD) via accelerometers (Actigraph wGT3X-BT, Pensacola, FL).
Time frame: 12 weeks
Energy Expenditure Changes
Patient energy expenditure (kcal) will be measured at pre- and 12-weeks post-intervention (mean ± SD) via accelerometers (Actigraph wGT3X-BT, Pensacola, FL).
Time frame: 12 weeks
Step Count Changes
Steps per day will be measured at pre- and 12-weeks post-intervention (mean ± SD) via accelerometers (Actigraph wGT3X-BT, Pensacola, FL).
Time frame: 12 weeks
Sedentary Behavior Changes
Sedentary time (minutes/wk) will be measured at pre- and 12-weeks post-intervention (mean ± SD) via accelerometers (Actigraph wGT3X-BT, Pensacola, FL).
Time frame: 12 weeks
Fidelity of Prioritize Personalize Prescribe Exercise (P3-EX)
The investigators will assess the degree to which Prioritize Personalize Prescribe EXercise (P3-EX) is implemented as intended by obtaining the selected American College of Sports Medicine strategy used to prioritize the cardiovascular disease risk factor chosen by the clinicians when there is multiple risk factors tied for the greatest risk.
Time frame: Throughout the 5-month study, at each clinicians' use of P3-EX to deliver an exercise prescription to a patient in the study (assessed once per clinician; anticipated 19-24 clinicians)
Usage Time of Prioritize Personalize Prescribe Exercise (P3-EX and ACSM-PAVS)
The investigators will obtain the time it takes in minutes for clinicians to prescribe the exercise prescription to each patient using P3-EX and ACSM-PAVS.
Time frame: Throughout the 5-month study, at each clinicians' use of P3-EX and ACSM-PAVS to deliver an exercise prescription to a patient in the study (assessed once per clinician; anticipated 19-24 clinicians)
Trial Satisfaction
Clinicians and patients will complete open-ended written questions to assess their satisfaction with key study components, to inform the design of a larger trial. Within 48 hours after completing the delivery of both Prioritize Personalize Prescribe Exercise (P3-EX) and American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS), clinicians will provide their thoughts on the recruitment procedures and the exercise prescription training they received. Patients will provide their thoughts on use of the Timeline Followback for Exercise and the exercise guidance Graduate Assistants gave them during virtual study visits after they complete the intervention. Responses will be coded and categorized to identify common themes.
Time frame: Within 48 hours after completing the delivery of both P3-EX and ACSM PAVS
Plan to share: Yes — The analyzable dataset for de-identified individual participant data (IPD) will be made available upon request and provided as supplementary material with any published manuscripts.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: All de-identified IPD will be available upon reasonable request with no time limit.
Access criteria: All de-identified IPD will be shared via email to researchers who reasonably request the dataset.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 9 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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