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Last Updated: May 25, 2025

CLINICAL TRIALS PROFILE FOR DEXMEDETOMIDINE


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505(b)(2) Clinical Trials for Dexmedetomidine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT03089905 ↗ A Study to Compare the Long-term Outcomes After Two Different Anaesthetics Recruiting Baylor College of Medicine Phase 3 2017-08-10 There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination NCT03089905 ↗ A Study to Compare the Long-term Outcomes After Two Different Anaesthetics Recruiting Boston Children's Hospital Phase 3 2017-08-10 There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination NCT03089905 ↗ A Study to Compare the Long-term Outcomes After Two Different Anaesthetics Recruiting Boston Children’s Hospital Phase 3 2017-08-10 There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination NCT03089905 ↗ A Study to Compare the Long-term Outcomes After Two Different Anaesthetics Recruiting Children's Hospital of Philadelphia Phase 3 2017-08-10 There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
New Combination NCT03089905 ↗ A Study to Compare the Long-term Outcomes After Two Different Anaesthetics Recruiting Erasmus Medical Center Phase 3 2017-08-10 There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dexmedetomidine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00095251 ↗ MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status Completed Vanderbilt University Phase 2 2004-08-01 Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).
NCT00095251 ↗ MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status Completed Vanderbilt University Medical Center Phase 2 2004-08-01 Delirium has recently been shown as a predictor of death, increased cost, and longer length of stay in ventilated patients. Sedative and analgesic medications relieve anxiety and pain, but may contribute to patients' transitioning into delirium. It is possible that modifying the paradigm for sedation using novel therapies targeted at different receptors, such as dexmedetomidine targeting alpha2 receptors and sparing the GABA receptors, could provide efficacious sedation yet reduce the development, duration, and severity of acute brain dysfunction (delirium).
NCT00142493 ↗ Effect of Affective Content on Drug Induced Amnesia of Episodic Memory Completed Memorial Sloan Kettering Cancer Center Phase 1 2004-09-01 The purpose of this research is to understand how some of the drugs commonly used in anesthesia impair memory. We are particularly interested in whether the emotion associated with a memory influences how well these drugs are able to block memory. We are studying four commonly used drugs-propofol, thiopental, midazolam, and dexmedetomidine, all of which may have slightly differing effects. We will also study an inactive substance, called a placebo, that should have no effect. The results of this study will provide information that will be useful in understanding how memory works, how these drugs affect memory, and possibly why some people don't have their memory blocked as easily as others.
NCT00205712 ↗ Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids Completed National Alliance for Research on Schizophrenia and Depression Phase 4 2003-02-01 Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00205712 ↗ Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids Completed Washington University School of Medicine Phase 4 2003-02-01 Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dexmedetomidine

Condition Name

Condition Name for Dexmedetomidine
Intervention Trials
Dexmedetomidine 123
Anesthesia 81
Delirium 55
Sedation 52
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Condition MeSH

Condition MeSH for Dexmedetomidine
Intervention Trials
Delirium 126
Pain, Postoperative 115
Emergence Delirium 45
Psychomotor Agitation 42
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Clinical Trial Locations for Dexmedetomidine

Trials by Country

Trials by Country for Dexmedetomidine
Location Trials
United States 459
Egypt 273
China 227
Korea, Republic of 118
Canada 53
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Trials by US State

Trials by US State for Dexmedetomidine
Location Trials
Ohio 37
Massachusetts 37
Texas 34
New York 33
Pennsylvania 32
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Clinical Trial Progress for Dexmedetomidine

Clinical Trial Phase

Clinical Trial Phase for Dexmedetomidine
Clinical Trial Phase Trials
Phase 4 478
Phase 3 142
Phase 2/Phase 3 64
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Clinical Trial Status

Clinical Trial Status for Dexmedetomidine
Clinical Trial Phase Trials
Completed 581
Recruiting 262
Not yet recruiting 201
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Clinical Trial Sponsors for Dexmedetomidine

Sponsor Name

Sponsor Name for Dexmedetomidine
Sponsor Trials
Assiut University 80
Yonsei University 48
Ain Shams University 40
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Sponsor Type

Sponsor Type for Dexmedetomidine
Sponsor Trials
Other 1652
Industry 140
NIH 21
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Dexmedetomidine: Clinical Trials, Market Analysis, and Projections

Introduction to Dexmedetomidine

Dexmedetomidine is an imidazole alpha-2 receptor agonist widely used in medical settings for its sedative, analgesic, and anti-anxiety properties. It is particularly valued for its ability to provide sedation without significant respiratory depression, making it a preferred choice in intensive care units (ICUs) and surgical settings.

Current Clinical Trials

Acute Stress Disorder (ASD) Trial

BioXcel Therapeutics has announced a collaboration with the University of North Carolina at Chapel Hill, funded by a grant from the U.S. Department of Defense, to evaluate the efficacy and safety of BXCL501 (sublingual dexmedetomidine) as a potential treatment for acute stress disorder (ASD). Enrollment for the Phase 2a efficacy and safety trial is expected to begin in the first half of 2025. This trial is significant, given that approximately 40 million Americans visit emergency departments annually after traumatic experiences[1].

Opioid Use Disorder (OUD) Trial

Another notable trial involves the use of BXCL501 for the potential treatment of opioid use disorder (OUD). This trial, funded by the National Institute on Drug Abuse (NIDA), is being led by Columbia University and aims to complete a 4-arm, 160-patient trial by 2024. The trial is part of broader efforts to address the opioid crisis, with fentanyl adulterated or associated with xylazine (FAAX) designated as an emerging threat by the White House Office of National Drug Control Policy[3].

End-of-Life Sedation Trial

The "Dexmedetomidine for the Reduction of End-of-life Agitation and for optiMised Sedation" (DREAMS) trial is a randomized controlled trial comparing dexmedetomidine with midazolam for sedation in palliative care patients. This trial aims to determine if dexmedetomidine is superior in reducing delirium, the use of breakthrough medications, and improving patient comfort as perceived by families and loved ones. The trial uses subcutaneous infusion, a preferred route in palliative care settings[4].

Market Analysis

Global Market Size and Growth

The global dexmedetomidine market was valued at USD 1.8 billion in 2023 and is projected to reach USD 3.1 billion by 2031, growing at a compound annual growth rate (CAGR) of 6.7% from 2024 to 2031. This growth is driven by increasing use in ICUs and surgical settings due to its efficacy as a sedative and analgesic. Innovations in drug formulations and delivery systems, along with a growing preference for dexmedetomidine over traditional sedatives, are key factors contributing to this expansion[2].

Market Segmentation

The dexmedetomidine market is segmented based on application (injectable, intranasal, intravenous), product (ICUs, operating rooms, ambulatory care, clinics), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). The report highlights that the market is experiencing notable growth due to the rise in critical care procedures and the demand for better sedation management[2].

Regional Market Insights

China's Dexmedetomidine Market

In China, the sales value of dexmedetomidine increased steadily from 2016 to 2019, with a significant boost in 2018 due to the "4+7" centralized procurement policy by the Chinese government. However, the COVID-19 pandemic led to a year-on-year decrease of 3.45% in 2020. Despite this, the market is expected to experience restorative growth as the pandemic's impact alleviates. The CAGR of sales value from 2016 to 2020 was 11.8%, indicating a high growth rate[5].

Market Projections

Future Growth Drivers

  • Increasing Use in Critical Care: The demand for dexmedetomidine is expected to rise due to its efficacy in intensive care units and surgical settings.
  • Innovations in Formulations: New delivery systems, such as sublingual and intranasal formulations, are likely to expand the market.
  • Preference Over Traditional Sedatives: The advantages of dexmedetomidine, including its sedative and analgesic effects without significant respiratory depression, are driving a preference over traditional sedatives.
  • Clinical Research and Trials: Ongoing and future clinical trials, such as those for ASD and OUD, could further expand the therapeutic applications of dexmedetomidine[2][3][4].

Challenges and Opportunities

  • COVID-19 Impact: While the pandemic had a temporary negative impact on the market, the sector is expected to recover as healthcare services normalize.
  • Regulatory Approvals: Government approvals and funding for clinical trials can significantly influence market growth.
  • Competitive Landscape: The competitive landscape, including pricing and regional variations, will continue to shape the market dynamics[5].

Key Takeaways

  • Dexmedetomidine is undergoing significant clinical trials for new indications, including acute stress disorder and opioid use disorder.
  • The global market for dexmedetomidine is projected to grow at a CAGR of 6.7% from 2024 to 2031.
  • Innovations in drug formulations and delivery systems are key drivers of market growth.
  • Regional markets, such as China, are expected to experience restorative growth post-pandemic.
  • Ongoing clinical research and trials are likely to expand the therapeutic applications of dexmedetomidine.

FAQs

What are the current clinical trials involving dexmedetomidine?

Current clinical trials include the evaluation of BXCL501 for acute stress disorder, opioid use disorder, and a comparison with midazolam for end-of-life sedation.

What is the projected growth rate of the global dexmedetomidine market?

The global dexmedetomidine market is expected to grow at a CAGR of 6.7% from 2024 to 2031.

How has the COVID-19 pandemic affected the dexmedetomidine market in China?

The pandemic led to a year-on-year decrease of 3.45% in 2020, but the market is expected to experience restorative growth as the pandemic's impact alleviates.

What are the key advantages of dexmedetomidine over traditional sedatives?

Dexmedetomidine offers sedative and analgesic effects without significant respiratory depression, anti-anxiety properties, and hemodynamic stability.

What are the primary segments of the dexmedetomidine market?

The market is segmented based on application (injectable, intranasal, intravenous), product (ICUs, operating rooms, ambulatory care, clinics), and geographical regions.

Sources

  1. BioXcel Therapeutics Announces U.S. Department of Defense Grant to University of North Carolina to Fund Study of BXCL501 (Sublingual Dexmedetomidine) for Treating Acute Stress Disorder. BioXcel Therapeutics. October 15, 2024.
  2. Dexmedetomidine Market Size, Share, Trends, Scope And Forecast. Market Research Intellect. December 2024.
  3. BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD). BioXcel Therapeutics. November 6, 2023.
  4. Dexmedetomidine Versus Midazolam for End-of-Life Sedation and Agitation. Research Protocols. September 4, 2024.
  5. Investigation Report on China's Dexmedetomidine Markets, 2016-2020 & 2021-2025. Business Wire. July 1, 2021.
Last updated: 2025-01-09

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