Pain in Aging Former Athletes, Master's Athletes, and Nonathletes (PAIN)

Pain in Athletes INtervention (PAIN): A Randomized Crossover Clinical Trial in Aging Former Athletes, Master's Athletes, and Nonathletes

The goal of this clinical trial is to determine how male and female former athletes experience pain and respond to moderate-intensity exercise (strength versus aerobic) compared with both current master's athletes and nonathletes.

The main questions this study aims to address are:

1. How do former athletes, master's athletes, and nonathletes experience pain?
2. How do different types of moderate-intensity exercise (strength versus aerobic exercise) influence pain in former athletes, master's athletes, and nonathletes?

Participants will complete 3 different testing sessions:

1. Baseline testing including assessments of strength, cardiorespiratory fitness, and pain;
2. Strength exercise: pain assessments will occur before and after moderate-intensity strength training exercise;
3. Aerobic exercise: pain assessments will occur before and after moderate-intensity aerobic exercise.

There will be a washout period of approximately one week or greater between each of the three different testing sessions. The order of conditions (strength versus aerobic exercise) will be randomized (crossover randomized trial design).

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Pain; Aging; Pain Management; Exercise Training; Aerobic Exercise; Sports; Athlete; Strength Training; Sports Medicine; Strength Training Effects
• Intervention / Treatment: Other: Moderate-Intensity Strength Exercise Intervention; Other: Moderate-Intensity Aerobic Exercise Intervention

Detailed Description

Two major health challenges facing midlife adults in our society are chronic pain and insufficient physical activity (PA). Chronic pain is highly prevalent among females and those who previously engaged in substantial vigorous PA, such as former competitive athletes. Exercise (i.e., a specific planned subtype of PA) is one of the best interventions for optimizing health, maintaining function, and preserving cardiorespiratory fitness - yet ironically often not continued among midlife adults who were highly physically active as youth and young adults in competitive sports. While PA and other lifestyle behaviors (e.g., sleep) likely influence pain processing and response to exercise, the mechanisms underlying pain in males and females with distinct PA trajectories are unknown. Pain is a common and critical barrier to regular exercise. Yet exercise has paradoxical effects on pain, generally increasing pain during exercise and providing pain relief after, i.e., exercise-induced hypoalgesia. While higher exercise intensities may lead to greater exercise-induced hypoalgesia, the greater pain and discomfort experienced during high-intensity exercise may prevent uptake, making moderate-intensity exercise a promising solution balancing physiological benefits and exercise-induced hypoalgesia. The investigators' long-term objective is to alleviate pain, increase PA, and improve health in midlife and aging adults. This randomized crossover clinical trial will determine how markedly different PA trajectories and sex influence pain, lifestyle behaviors, and the pain response to exercise (exercise-induced hypoalgesia). Given that pain is affected by PA and sports history, this proposal will examine pain processing in midlife males and females with distinct PA trajectories evenly split across 3 unique groups: 1) former athletes no longer participating in sports; 2) master's athletes; and 3) nonathletes.

In order to compare pain perceptions and processing in former athletes, master's athletes, and nonathletes, quantitative sensory testing and validated questionnaires will be used. Lifestyle behaviors (PA and sleep) will be assessed using wearable devices. Moderate-intensity strength and aerobic exercise interventions will be included to determine how these influence the pain perceptions of former athletes, current master's athletes and nonathletes. Full participation will involve completing three in-person sessions including baseline assessment session and two intervention sessions (i.e., follow-up 1 and follow-up 2 at approximately 1 week intervals) at Marquette University as well as wearing a small physical activity monitor for 2 weeks following baseline session and an OURA ring for the duration of the study.

Aim 1: Determine the impact of physical activity history (group) and sex on (1a) pain processing and (1b) lifestyle behaviors in midlife adults (former athletes, master's athletes, and nonathletes).

Aim 2: Quantify the effect of physical activity history (group) and sex on the change in pain response to moderate-intensity exercise and explore differences in pain response to exercise modality (i.e., strength versus aerobic).

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacob J Capin, DPT, PhD; Phone Number: 414-288-7865; Email: jacob.capin@marquette.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53233
      • Recruiting
      • Marquette University
      • Contact: Jacob J Capin, DPT, PhD; Phone Number: 4142887865; Email: jacob.capin@marquette.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria (General):

• Age: 35 years through 65 years
• Current master's athlete, former competitive athletes, or non-athlete control (see details below)
• Ability to participate in exercise and exercise testing based on the Physical Activity Readiness Questionnaire (PAR-Q+)

Exclusion Criteria (General):

• Currently pregnant or planning to become pregnant during the study
• Currently taking heart rate lowering medications (e.g., betablockers) that would impact exercise testing
• Contraindications to ice such as Raynaud's, cryoglobulinemia, cold urticaria, and/or impaired circulation or sensation
• Fibromyalgia and/or chronic regional pain syndrome (CRPS)
• Myocardial infarction or pulmonary embolism in the last 12 months, active cancer, a pacemaker, or any additional condition or disease that would preclude the individual from being able to perform the tests safely

Participants will be enrolled into one of the following three mutually exclusive groups according to the following criteria:

1. Former Competitive Athlete: Prior participation in competitive sports at the Tier 3 level or above as per McKay et al. (2022): i.e., "national-level representatives who are performing structured and/or periodized training and are developing proficiency in skills required to perform their sport at the highest level; this tier includes individuals participating in Provincial/State or Academy Programs" or higher participation in sport; Not currently participating in any recreational or competitive sports over the last 5 years (Tier 2 or above)
2. Master's Athlete: Currently (within the past year) participating in sports at the Tier 2 level or above (i.e., committed to sports-specific training at least 3 times per week with the intent to compete)(McKay et al., 2022)
3. Nonathlete Control: No prior participation in sport at the Tier 3 (Highly Trained/National) Level or above and not currently participating in any competitive sports (i.e., Tier 2 or above) (McKay et al., 2022) for at least 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Former Competitive Athletes; Former competitive athletes will complete baseline testing as well as two separate experimental conditions in randomized condition order: 1) moderate-intensity strength exercise intervention; and 2) moderate-intensity aerobic exercise intervention.	Other: Moderate-Intensity Strength Exercise Intervention; Participants will perform 10 isometric knee extension repetitions unilaterally on both sides separately for 10 seconds with each repetition at 50% of their maximal volitional contraction (MVC) on an electromechanical dynamometer. Participants will be provided 50 seconds rest in between repetitions. Numeric pain intensity ratings (0-10) and rating of perceived exertion (RPE) will be recorded before, during, and following exercise. Quantitative Sensory Testing (i.e., PPTs and TSP) will be assessed before and after the exercise intervention. If there is a more affected limb with regards to pain, the less affected limb will be exercised first. If there is not a more affected limb, side will be randomized. A warm up will be performed prior to the intervention.; Other: Moderate-Intensity Aerobic Exercise Intervention; Participants will complete aerobic exercise at 40-59% of their heart rate reserve (HRR) through the mode of incline walking on a treadmill for 30 minutes with a 2 -minute warm up and 2-minute cool down with a target intensity of ~50% HRR. Adjustments will be made to the incline and speed throughout the intervention as needed to maintain 40-59% HRR range. Numeric pain intensity ratings (0-10) and rating of perceived exertion (RPE) will be recorded before, during, and following exercise. Quantitative Sensory Testing (i.e., PPTs and TSP) will be assessed before and after the exercise intervention. Heart rate will be measured throughout the walking intervention to ensure the participant is within the targeted range for moderate intensity; pre- and post-aerobic intervention heart rate and blood pressure will be taken.
Active Comparator: Master's Athletes; Master's Athletes will complete baseline testing as well as two separate experimental conditions in randomized condition order: 1) moderate-intensity strength exercise intervention; and 2) moderate-intensity aerobic exercise intervention.	Other: Moderate-Intensity Strength Exercise Intervention; Participants will perform 10 isometric knee extension repetitions unilaterally on both sides separately for 10 seconds with each repetition at 50% of their maximal volitional contraction (MVC) on an electromechanical dynamometer. Participants will be provided 50 seconds rest in between repetitions. Numeric pain intensity ratings (0-10) and rating of perceived exertion (RPE) will be recorded before, during, and following exercise. Quantitative Sensory Testing (i.e., PPTs and TSP) will be assessed before and after the exercise intervention. If there is a more affected limb with regards to pain, the less affected limb will be exercised first. If there is not a more affected limb, side will be randomized. A warm up will be performed prior to the intervention.; Other: Moderate-Intensity Aerobic Exercise Intervention; Participants will complete aerobic exercise at 40-59% of their heart rate reserve (HRR) through the mode of incline walking on a treadmill for 30 minutes with a 2 -minute warm up and 2-minute cool down with a target intensity of ~50% HRR. Adjustments will be made to the incline and speed throughout the intervention as needed to maintain 40-59% HRR range. Numeric pain intensity ratings (0-10) and rating of perceived exertion (RPE) will be recorded before, during, and following exercise. Quantitative Sensory Testing (i.e., PPTs and TSP) will be assessed before and after the exercise intervention. Heart rate will be measured throughout the walking intervention to ensure the participant is within the targeted range for moderate intensity; pre- and post-aerobic intervention heart rate and blood pressure will be taken.
Active Comparator: Nonathlete Controls; Nonathlete Controls will complete baseline testing as well as two separate experimental conditions in randomized condition order: 1) moderate-intensity strength exercise intervention; and 2) moderate-intensity aerobic exercise intervention.	Other: Moderate-Intensity Strength Exercise Intervention; Participants will perform 10 isometric knee extension repetitions unilaterally on both sides separately for 10 seconds with each repetition at 50% of their maximal volitional contraction (MVC) on an electromechanical dynamometer. Participants will be provided 50 seconds rest in between repetitions. Numeric pain intensity ratings (0-10) and rating of perceived exertion (RPE) will be recorded before, during, and following exercise. Quantitative Sensory Testing (i.e., PPTs and TSP) will be assessed before and after the exercise intervention. If there is a more affected limb with regards to pain, the less affected limb will be exercised first. If there is not a more affected limb, side will be randomized. A warm up will be performed prior to the intervention.; Other: Moderate-Intensity Aerobic Exercise Intervention; Participants will complete aerobic exercise at 40-59% of their heart rate reserve (HRR) through the mode of incline walking on a treadmill for 30 minutes with a 2 -minute warm up and 2-minute cool down with a target intensity of ~50% HRR. Adjustments will be made to the incline and speed throughout the intervention as needed to maintain 40-59% HRR range. Numeric pain intensity ratings (0-10) and rating of perceived exertion (RPE) will be recorded before, during, and following exercise. Quantitative Sensory Testing (i.e., PPTs and TSP) will be assessed before and after the exercise intervention. Heart rate will be measured throughout the walking intervention to ensure the participant is within the targeted range for moderate intensity; pre- and post-aerobic intervention heart rate and blood pressure will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Tolerance	The maximum stimulus intensity that the participant can tolerate will be measured by placing a thermode (Q-Sense, Medoc) on the ventral forearm. Three trials will be completed with the baseline temperature set at 35°C that increases at a rate of 1°/s with a maximum temperature of 50°C. Participants will be asked to press a timing device when they can no longer tolerate the temperature (i.e., pain tolerance), and this temperature will be recorded as the maximum stimulus intensity.	Baseline (Aim 1a)
Pressure Pain Threshold (PPT)	Pressure Pain Thresholds (PPTs) will be used to measure group differences in pain sensitivity at baseline and the hypoalgesic response (increase in PPTs) during the exercise sessions with a pressure algometer (Algomed, Medoc) at the exercising limb, contralateral limb, and systemically at the right upper trapezius muscle. Two trials separated by a 10-second interval will be performed at each site with a 1cm^2 rubber tip at a rate of 50 kPA/sec. Participants will be instructed to press a timing device when the pressure first changes to pain (i.e., pain threshold). Practice trials with be performed on the fourth digit fingernail bed prior to formal assessment at quad/trap and order will be randomized. The change scores from pre- to post-strength exercise and from pre- to post-aerobic exercise will be used as the primary outcome in Aim 2.	Baseline, Pre-/Post-Exercise at Follow-up Session 1 (approximately 1 week after baseline), and Pre-/Post-Exercise at Follow-up Session 2 (approximately 2 weeks after baseline) (Aim 2)
Physical Activity - Step Counts	Physical activity (PA) will be monitored continuously using an activPAL activity monitor. Step counts will be recorded as the average number of steps taken per day.	Remote monitoring for 2 weeks during the study (Aim 1b)
Sedentary Behavior	Total sedentary behavior will be assessed using an activPAL activity monitor and recorded as the average daily amount of time in wakeful sedentary behavior (hours:minutes).	Remote monitoring for 2 weeks during the study (Aim 1b)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (pain perception)	The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity-SF v.1.0 3a will be collected at baseline to capture average pain and worst pain intensity over the past 7 days and right now. The survey has 3 questions where respondents rates pain from no pain (1) to very severe pain (5). The total raw score ranges from 3 to 15 with higher scores indicating more severe pain.	Baseline
Michigan Body Map for Pain (pain perception)	Pain distribution or location at rest and with movement will be assessed using the Michigan Body Map for Pain (validated questionnaire).	Baseline
Temporal Summation of Pain (TSP)	Temporal summation of pain (TSP) is an increase in pain with a repetitive or constant-intensity, noxious stimulus and represents central pain facilitation. A custom-made pressure pain device, used frequently in the assessment of exercise-induced hypoalgesia, will assess TSP and consists of an 8 x 1.5-mm Lucite edge (Romus Inc., Milwaukee, WI) placed on the mid portion of the middle phalanx of the right index finger for 2 min. A 10-N force (equivalent to a 1-kg mass) will be applied to the Lucite edge, and participants will be asked to press a timing device when the pressure first changes to pain (i.e., pain threshold) and to rate the intensity of pain on a 0-10 numerical pain rating scale every 20-s throughout the test. The increase in the pain intensity during the 2-minute test represents TSP.	Baseline, Pre-/Post-Exercise at Follow-up Session 1 (approximately 1 week after baseline), and Pre-/Post-Exercise at Follow-up Session 2 (approximately 2 weeks after baseline)
Condition Pain Modulation (CPM)	Condition pain modulation (CPM) is the concept that pain inhibits pain and will be used to indirectly measure the efficiency of descending inhibitory pathways. For the CPM protocol, PPTs (test stimulus) will be measured using a pressure algometer (AlgoMed, Medoc) as described above at the quadriceps and upper trapezius muscles with and without the participant's foot submerged in an ice water bath (conditioning stimulus). An increase in PPTs during the conditioning stimulus represents the pain inhibits pain phenomenon, whereas no change or decrease in PPTs indicates low CPM efficiency.	Baseline
Numeric Pain Rating Scale	The numeric pain rating scale (0-10) will be used to assess pain before, during, and after the strength and aerobic exercise interventions.	Pre-/Post-Exercise at Follow-up Session 1 (approximately 1 week after baseline) and Pre-/Post-Exercise at Follow-up Session 2 (approximately 2 weeks after baseline)
Prolonged Bouts of Sedentary Behavior	Prolonged (>1 hours) bouts of sedentary behavior will be assessed using an activPAL activity monitor.	Remote monitoring for 2 weeks during the study (Aim 1b)
Sleep Duration	Sleep duration will be monitored remotely throughout the study using an Oura Ring. Sleep duration will be measured in time (hours:minutes) with greater values indicating longer sleep.	Remote monitoring throughout the study (i.e., about 2-3 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating of Perceived Exertion	Rating of Perceived Exertion (RPE) will be assessed before, during, and after the strength and aerobic exercise interventions. The RPE scale ranges from 6 (no exertion at all) to 20 (maximal exertion) with high values indicating greater exertion.	Baseline, Pre-/Post-Exercise at Follow-up Session 1 (approximately 1 week after baseline), and Pre-/Post-Exercise at Follow-up Session 2 (approximately 2 weeks after baseline)
Knee Extension Strength	Participants will complete standardized isometric strength testing on an electromechanical dynamometer using our established protocol. Following submaximal warm-up efforts, participants will complete 5 maximal effort (i.e., 100%) isometric knee extensions (i.e., maximal volitional contractions [MVCs]) with rest breaks (~1 minute) in between. The order of limbs will be randomized unless the participant has any knee or lower extremity pain prior to testing in which case the less involved limb will be tested first. The peak value from the MVC for each limb will be used to determine the target intensity of the moderate-intensity strength exercise intervention.	Baseline
Cardiorespiratory Fitness Testing	Participants will perform the submaximal aerobic 3-minute YMCA Step Test using a 12-inch step at a stepping rate of 24 steps/min set via a metronome set to 96 beats/min for each foot movement. Following 3 minutes of stepping, the participant immediately stops, sits down, and remains still. The total one-minute post-exercise heart rate is the participant's score.	Baseline
Injury and Surgical History	A detailed injury and surgical history will be captured by a licensed physical therapist or other trained study personnel using an injury and surgical history questionnaire.	Baseline
Sleep Latency	Sleep latency will be monitored remotely throughout the study using an Oura Ring. Sleep latency is the time (in minutes) it takes to fall asleep.	Remote monitoring throughout the study (i.e., about 2-3 weeks)
Physical Activity - Metabolic Equivalents of Task (METs)	Physical activity (PA) will be monitored continuously using an activPAL activity monitor. Metabolic equivalents of task, an indicator of overall activity level, will be recorded.	Remote monitoring for 2 weeks during the study
Sleep Efficiency	Sleep efficiency will be monitored remotely throughout the study using an Oura Ring. Sleep efficiency is the percentage of time in bed spent asleep (0-100%). Higher values indicate greater sleep efficiency, whereas lower values are indicative of restlessness.	Remote monitoring throughout the study (i.e., about 2-3 weeks)

Collaborators and Investigators

• Sponsor: Marquette University
• Investigators: Principal Investigator: Jacob J Capin, DPT, PhD, Marquette University

Publications and helpful links

General Publications

• Drawer S, Fuller CW. Propensity for osteoarthritis and lower limb joint pain in retired professional soccer players. Br J Sports Med. 2001 Dec;35(6):402-8. doi: 10.1136/bjsm.35.6.402.
• McKay AKA, Stellingwerff T, Smith ES, Martin DT, Mujika I, Goosey-Tolfrey VL, Sheppard J, Burke LM. Defining Training and Performance Caliber: A Participant Classification Framework. Int J Sports Physiol Perform. 2022 Feb 1;17(2):317-331. doi: 10.1123/ijspp.2021-0451. Epub 2022 Dec 29.
• Wewege MA, Jones MD. Exercise-Induced Hypoalgesia in Healthy Individuals and People With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis. J Pain. 2021 Jan;22(1):21-31. doi: 10.1016/j.jpain.2020.04.003. Epub 2020 Jun 26.
• Geisler M, Herbsleb M, de la Cruz F, von Au S, Schumann A, Croy I, Bar KJ. Profound neuronal differences during exercise-induced hypoalgesia between athletes and non-athletes revealed by functional near-infrared spectroscopy. J Physiol. 2026 Feb 26. doi: 10.1113/JP289766. Online ahead of print.
• Purcell C, Duignan C, Fullen BM, Ryan S, Ward T, Caulfield B. Comprehensive assessment and classification of upper and lower limb pain in athletes: a scoping review. Br J Sports Med. 2023 May;57(9):535-542. doi: 10.1136/bjsports-2022-106380. Epub 2023 Feb 9.
• Simon JE, Docherty CL. The Impact of Previous Athletic Experience on Current Physical Fitness in Former Collegiate Athletes and Noncollegiate Athletes. Sports Health. 2017 Sep/Oct;9(5):462-468. doi: 10.1177/1941738117705311. Epub 2017 May 5.
• Schwenk TL, Gorenflo DW, Dopp RR, Hipple E. Depression and pain in retired professional football players. Med Sci Sports Exerc. 2007 Apr;39(4):599-605. doi: 10.1249/mss.0b013e31802fa679.
• Simon JE, Lorence M, Docherty CL. Health-Related Quality of Life in Former National Collegiate Athletic Association Division I Collegiate Athletes Compared With Noncollegiate Athletes: A 5-Year Follow-Up. J Athl Train. 2021 Mar 1;56(3):331-338. doi: 10.4085/107-20. Epub 2021 Feb 18.
• Dzau VJ, Pizzo PA. Relieving pain in America: insights from an Institute of Medicine committee. JAMA. 2014 Oct 15;312(15):1507-8. doi: 10.1001/jama.2014.12986. No abstract available.
• Lachman ME. Mind the Gap in the Middle: A Call to Study Midlife. Res Hum Dev. 2015;12(3-4):327-334. doi: 10.1080/15427609.2015.1068048. Epub 2015 Aug 27.
• Street JH, Larson AM, de Guia R, Bansal N, Hunter SK, Capin JJ. The paradox of sport: adolescent athletes are highly sedentary across competition, practice, and rest days. BMC Sports Sci Med Rehabil. 2026 Jan 22;18(1):86. doi: 10.1186/s13102-026-01539-6.
• Piacentine LB, Wolf TL, Capin JJ. Transitioning to life after sport: empowering former college varsity athletes to live more healthfully. Front Sports Act Living. 2026 Jan 12;7:1713432. doi: 10.3389/fspor.2025.1713432. eCollection 2025.
• Larson A, Street JH, de Guia R, Capin JJ. Sport training day affects adolescent athletes' sleep schedules. Front Sports Act Living. 2026 Jan 27;7:1731173. doi: 10.3389/fspor.2025.1731173. eCollection 2025.
• Capin JJ, Ridgers ND, Street JH, Fial A, Tomkinson GR. Activity levels across the intensity spectrum in athletes: a systematic review protocol. BMJ Open Sport Exerc Med. 2024 Aug 16;10(3):e002148. doi: 10.1136/bmjsem-2024-002148. eCollection 2024.
• Street JH, Boos ZP, Fial A, Lennon SL, Smith CS, Creasy SA, Hunter SK, Farquhar WB, Capin JJ. Long-term function, body composition and cardiometabolic health in midlife former athletes: a scoping review. BMJ Open Sport Exerc Med. 2023 Oct 27;9(4):e001605. doi: 10.1136/bmjsem-2023-001605. eCollection 2023.
• Capin JJ, Wolf TL, Street JH, Smith CS, Lennon SL, Farquhar WB, Hunter SK, Piacentine LB. Midlife health crisis of former competitive athletes: dissecting their experiences via qualitative study. BMJ Open Sport Exerc Med. 2024 May 9;10(2):e001956. doi: 10.1136/bmjsem-2024-001956. eCollection 2024.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 15, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Pain; Aging; Quantitative Sensory Testing; Sport; Former Athlete; Master's Athlete; Randomized Crossover Clinical Trial
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Agnosia; Motor Activity
• Other Study ID Numbers: IRB#5050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared in accordance with policies of the funder should this study receive extramural funding.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No