Biologic Injection For Adults With Lumbar Disc Herniation (BMAC)

Bone Marrow Aspirate Concentrate Injection With MRI's - A Prospective Randomized Control Trial

The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation.

The main questions it aims to answer are:

• Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)?
• Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone?

Participants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery.

Researchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit.

Participants will:

• Have surgery (microdiscectomy) with or without the injection.
• Complete pain and disability questionnaires at several times over 2 years.
• Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health.
• Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain; Lumbar Disc Herniation; Intervertebral Disc Displacement; Degenerative Disc Disease; Bone Marrow Aspirate Concentrate; DDD; CLBP - Chronic Low Back Pain; Degenerative Disc Disease, Lumbar; Disc Herniation, Lumbar; Chronic Low Back Pain (CLBP); Degenerative Disc Disease Lumbar
• Intervention / Treatment: Other: Bone Marrow Aspirate Concentrate (BMAC)

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

Contacts and Locations

• Study Contact: Name: Research Assistant; Phone Number: 5163539723; Email: adr4017@med.cornell.edu
• Study Contact Backup: Name: Research Assistant; Email: evw4005@med.cornell.edu

Study Locations

• United States
  • New York
    • Manhattan, New York, United States, 10065
      • NewYork-Presbyterian/Weill Cornell Medical Center
      • Contact: Research Assistant; Phone Number: 5163539723; Email: adr4017@med.cornell.edu
      • Contact: Research Assistant; Email: evw4005@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female patients ≥ 18 years of age
• Clinically and/or radiographically (MRI) confirmed diagnosis of degenerative disc disease of the lumbar spine, lumbar disc herniation, and indication for lumbar microdiscectomy surgery
• Unresponsive to conservative/non-operative treatment for >3 months
• Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups and observe the treatment plan

Exclusion Criteria:

• Prisoners
• Individuals who are not yet adults (infants, children, teenagers)
• Individuals who are not able to clearly understand English
• Adults with diminished capacity to consent
• Major cognitive impairment causing to inability to understand and provide informed consent
• Active malignancy
• Active chronic or acute infection
• Autoimmune disorder that impacts the lumbar spine (ankylosing spondylitis, lupus e.g.)
• Bone marrow-derived or non-bone marrow-derived cancer
• Low platelet count or clotting disorders
• Prior surgery at the level to be treated or the adjacent level

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BMAC Group; Administration of one 1-2cc intradiscal Bone Marrow Aspirate Concentrate (BMAC) injection during lumbar microdiscectomy surgery.	Other: Bone Marrow Aspirate Concentrate (BMAC); Dosage Form: Autologous intradiscal injection Dosage: 1-2 cc's Frequency: Once, during surgery Duration: N/A; Other Names: Bone Marrow Aspirate (BMA); Bone Marrow Aspirate Stem Cell Concentrate (BMAC); Bone Marrow Concentrate (BMC)
No Intervention: Control Group; Standard of care lumbar microdiscectomy surgery without the BMAC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Intervertebral Disc Hydration at 3 Months	MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.	Baseline and 3 Months post-operation
Change from Baseline in Intervertebral Disc Hydration at 1 Year	MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.	Baseline and 1 year post-operation
Change from Baseline in Intervertebral Disc Hydration at 2 Years	MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.	Baseline and 2 years post-operation
Change from Baseline in Proteoglycan Content at 3 Months	MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.	From enrollment to 3 Months post-operation
Change from Baseline in Proteoglycan Content at 1 Year	MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.	From enrollment to 1 year post-operation
Change from Baseline in Proteoglycan Content at 2 Years	MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.	From enrollment to 2 years post-operation
Change from Baseline in Disc Height Index at 3 Months	Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.	From enrollment to 3 months post-operation
Change from Baseline in Disc Height Index at 1 Year	Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.	From enrollment to 1 year post-operation
Change from Baseline in Disc Height Index at 2 Years	Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.	From enrollment to 2 years post-operation
Change from Baseline in Pfirrmann Grade at 3 Months	Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus	From enrollment to 3 months post-operation
Change from Baseline in Pfirrmann Grade at 1 Year	Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus	From enrollment to 1 year post-operation
Change from Baseline in Pfirrmann Grade at 2 Years	Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus	From enrollment to 2 years post-operation
Change from Baseline in Nucleus Pulposus Size at 3 Months	The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.	From enrollment to 3 months post-operation
Change from Baseline in Nucleus Pulposus Size at 1 Year	The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.	From enrollment to 1 year post-operation
Change from Baseline in Nucleus Pulposus Size at 2 Years	The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.	From enrollment to 2 years post-operation
Change from Baseline in NOCISCORE at 3 Months	Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.	From enrollment to 3 months post-operation
Change from Baseline in NOCISCORE at 1 Year	Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.	From enrollment to 1 year post-operation
Change from Baseline in NOCISCORE at 2 Years	Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.	From enrollment to 2 years post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Patient Reported Pain at 3 Months	The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.	From enrollment to 3 Months post-operation
Change from Baseline in Patient Reported Pain at 6 Months	The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.	From enrollment to 6 Months post-operation
Change from Baseline in Patient Reported Pain at 1 Year	The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.	From enrollment to 1 Year post-operation
Change from Baseline in Patient Reported Pain at 2 Years	The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.	From enrollment to 2 years post-operation
Change from Baseline in Patient Reported Disability at 3 Months	The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).	From enrollment to 3 Months post-operation
Change from Baseline in Patient Reported Disability at 6 Months	The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).	From enrollment to 6 Months post-operation
Change from Baseline in Patient Reported Disability at 1 Year	The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).	From enrollment to 1 year post-operation
Change from Baseline in Patient Reported Disability at 2 Years	The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).	From enrollment to 2 years post-operation
Change from Baseline in SI-Score at 3 Months	Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).	From enrollment to 3 months post-operation
Change from Baseline in SI-Score at 1 Year	Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).	From enrollment to 1 year post-operation
Change from Baseline in SI-Score at 2 Years	Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).	From enrollment to 2 years post-operation

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Aclarion
• Investigators: Principal Investigator: Roger Hartl, MD, NewYork Presbyterian-Weill Cornell Medicine

Publications and helpful links

General Publications

• Orozco L, Soler R, Morera C, Alberca M, Sanchez A, Garcia-Sancho J. Intervertebral disc repair by autologous mesenchymal bone marrow cells: a pilot study. Transplantation. 2011 Oct 15;92(7):822-8. doi: 10.1097/TP.0b013e3182298a15.
• Pettine KA, Murphy MB, Suzuki RK, Sand TT. Percutaneous injection of autologous bone marrow concentrate cells significantly reduces lumbar discogenic pain through 12 months. Stem Cells. 2015 Jan;33(1):146-56. doi: 10.1002/stem.1845.
• Yoshikawa T, Ueda Y, Miyazaki K, Koizumi M, Takakura Y. Disc regeneration therapy using marrow mesenchymal cell transplantation: a report of two case studies. Spine (Phila Pa 1976). 2010 May 15;35(11):E475-80. doi: 10.1097/BRS.0b013e3181cd2cf4.
• Zhang W, Sun T, Li Y, Yang M, Zhao Y, Liu J, Li Z. Application of stem cells in the repair of intervertebral disc degeneration. Stem Cell Res Ther. 2022 Feb 11;13(1):70. doi: 10.1186/s13287-022-02745-y.
• Elabd C, Centeno CJ, Schultz JR, Lutz G, Ichim T, Silva FJ. Intra-discal injection of autologous, hypoxic cultured bone marrow-derived mesenchymal stem cells in five patients with chronic lower back pain: a long-term safety and feasibility study. J Transl Med. 2016 Sep 1;14(1):253. doi: 10.1186/s12967-016-1015-5.
• Mochida J, Sakai D, Nakamura Y, Watanabe T, Yamamoto Y, Kato S. Intervertebral disc repair with activated nucleus pulposus cell transplantation: a three-year, prospective clinical study of its safety. Eur Cell Mater. 2015 Mar 20;29:202-12; discussion 212. doi: 10.22203/ecm.v029a15.
• Noriega DC, Ardura F, Hernandez-Ramajo R, Martin-Ferrero MA, Sanchez-Lite I, Toribio B, Alberca M, Garcia V, Moraleda JM, Gonzalez-Vallinas M, Sanchez A, Garcia-Sancho J. Treatment of Degenerative Disc Disease With Allogeneic Mesenchymal Stem Cells: Long-term Follow-up Results. Transplantation. 2021 Feb 1;105(2):e25-e27. doi: 10.1097/TP.0000000000003471. No abstract available.
• Jerome MA, Lutz C, Lutz GE. Risks of Intradiscal Orthobiologic Injections: A Review of the Literature and Case Series Presentation. Int J Spine Surg. 2021 Apr;15(s1):26-39. doi: 10.14444/8053. Epub 2021 Apr 21.
• Comella K, Silbert R, Parlo M. Effects of the intradiscal implantation of stromal vascular fraction plus platelet rich plasma in patients with degenerative disc disease. J Transl Med. 2017 Jan 13;15(1):12. doi: 10.1186/s12967-016-1109-0.

Helpful Links

• Cleveland Clinic: Bone Marrow Concentrate (BMC)

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: lumbar disc herniation; low back pain; degenerative disc disease; bone marrow aspirate concentrate; intervertebral disc displacement
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Intervertebral Disc Displacement; Low Back Pain; Intervertebral Disc Degeneration
• Other Study ID Numbers: 24-09027977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Anyone who wishes to access the data, for any purpose, may do so indefinitely at (Link to be included).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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