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Last Updated: May 20, 2025

CLINICAL TRIALS PROFILE FOR OXYCODONE


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505(b)(2) Clinical Trials for Oxycodone

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
OTC NCT00245375 ↗ A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT00245375 ↗ A Trial Comparing Combination Therapy of Acetaminophen Plus Ibuprofen Versus Tylenol #3 for the Treatment of Pain After Outpatient Surgery Completed Nova Scotia Health Authority N/A 2005-01-01 Increasingly in general surgery, the investigators are conducting outpatient day surgery. Ambulatory surgery currently comprises 60 to 70% of surgeries performed in North America. These patients all require some form of analgesia which can be taken at home in the first few days after the surgery. The current standard at the investigators' centre and many others in the maritime provinces is to provide a prescription for oral acetaminophen plus codeine or oxycodone (Tylenol #3®, Percocet ®). Some patients may receive more potent opioids such as oral hydromorphone (Dilaudid®). Unfortunately, the most commonly prescribed medication (Tylenol #3®) is often poorly tolerated by patients, has several undesirable side effects, and may not provide effective pain relief. In the investigators' experience, non-steroidal anti-inflammatory drugs (NSAIDs) are uncommonly a routine addition to the home analgesic regimen. Tylenol #3®, in the investigators' experience and opinion, is a poor post surgical pain medication. They hope to show that a combination of ibuprofen and acetaminophen is better for pain relief after these procedures. The combination of acetaminophen and ibuprofen would be a safe, cheap, and readily available regimen. Unfortunately, as the prescribing practices of surgeons are old habits, it will require a very convincing argument to get them to change their practices. A randomized controlled trial comparing these two regimens, the investigators hope, would be a powerful enough argument. The hypothesis of this study, therefore, is that the pain control provided by a combination of acetaminophen plus ibuprofen (650 mg/400 mg four times per day) will be superior to Tylenol #3® (600 mg acetaminophen/60 mg codeine/15 mg caffeine four times per day). This study will attempt to enroll 150 patients in total. Eligible patients will be identified by their attending surgeon and contacted by study personnel. Patients who enroll in the study will undergo their surgery in the usual manner. After the surgery, in the recovery room, once they are ready to go home, they will be randomized to receive combination A or B and be given a week's worth of pain medication. They will then go home and take this medication as directed. They will record their pain intensity and pain relief once per day using a diary provided in the study package. One week after their surgery, they will return to the hospital clinic and be seen by the study nurse. They will hand over the diary and any unused medication. They will also be asked several questions regarding their overall satisfaction, incidence of side effects, and how long until they were pain free. The risks of participating in this study are minimal from the risks inherent to the procedures and medications the patients would receive within the standard of care. Ibuprofen is a commonly used NSAID which is widely available over the counter and has an established safety profile. The most common adverse effects of ibuprofen and other NSAIDs are gastrointestinal bleeding and ulceration. Other less common adverse effects include nephrotoxicity, hypersensitivity reactions, hepatic dysfunction (longterm use), and cognitive dysfunction. The investigators' patients will be selected to exclude those most at risk for these complications (see exclusion criteria). Acetaminophen has few side effects, with no adverse effects on platelet function and no evidence of gastric irritation.
OTC NCT01588158 ↗ Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery Terminated Massachusetts General Hospital Phase 4 2012-07-01 Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry. There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008. Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief. It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certainly true in our practice. This seems to be based primarily on the outliers, and intended to avoid confrontation with patients that desire opioids; however, most patients take little or no narcotic pain medication, and many who do use the opioids complain of the side effects-nausea and pruritis in particular. It is therefore not clear whether routine opioids is the optimal pain management strategy after carpal tunnel release. In the study of Stahl et al. from Israel, patients were prescribed acetaminophen rather than opioids after carpal tunnel release and only 20 of 50 patients used acetaminophen; 30 patients did not use acetaminophen or other pain medication at all after the operation. Our aim is to determine if there is a difference in satisfaction with pain relief between patients advised to take opioids compared to patients advised to use over the counter acetaminophen after carpal tunnel release under local anesthesia. A secondary aim is to determine if personal factors account for more of the variability in satisfaction with pain relief than opioid strategy.
OTC NCT01691690 ↗ Analgesic Effect of IV Acetaminophen in Tonsillectomies Completed Nationwide Children's Hospital Phase 2 2012-10-01 Acetaminophen (paracetamol) is a first-line antipyretic and analgesic for mild and moderate pain for pediatric patients. Its common use (particularly in oral form) is underscored by its wide therapeutic window, safety profile, over the counter accessibility, lack of adverse systemic effects (as compared with NSAIDS and opioids) when given in appropriate doses. Although the exact anti-nociceptive mechanisms of acetaminophen continue to be elucidated, these mechanisms appear to be multi-factorial and include central inhibition of the cyclo-oxygenase (COX) enzyme leading to decreased production of prostaglandins from arachidonic acid, interference with serotonergic descending pain pathways, indirect activation of cannabinoid 1 (CB1) receptors and inhibition of nitric oxide pathways through N-methyl-D-aspartate (NMDA) or substance P. Of the above mechanisms, the most commonly known is that of central inhibition of COX enzymes by which the decreased production of prostaglandins diminish the release of excitatory transmitters of substance P and glutamate which are both involved in nociceptive transmission (Anderson, 2008; Smith, 2011). To date, several studies have shown acetaminophen's opioid sparing effect in the pediatric population when given by the rectal or intravenous routes (Korpela et al, 1999; Dashti et al, 2009; Hong et al, 2010).
OTC NCT02929589 ↗ Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy Suspended Mike O'Callaghan Federal Hospital Phase 3 2018-07-05 This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
OTC NCT02929589 ↗ Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy Suspended Mike O'Callaghan Military Hospital Phase 3 2018-07-05 This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Oxycodone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000273 ↗ A Laboratory Model for Heroin Abuse Medications - 8 Completed National Institute on Drug Abuse (NIDA) Phase 2 1995-08-01 The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00000273 ↗ A Laboratory Model for Heroin Abuse Medications - 8 Completed New York State Psychiatric Institute Phase 2 1995-08-01 The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration."
NCT00027014 ↗ Herb-Opioid Interactions Completed National Center for Complementary and Integrative Health (NCCIH) Phase 4 2001-09-01 This is a series of studies in healthy volunteers to assess the potential for adverse interactions between St. John's wort (SJW) extract and two narcotic (opioid) pain medications: oxycodone and fentanyl. In the case of oxycodone, we are interested in whether SJW treatment promotes the metabolism of oxycodone, such that it lowers the effectiveness of standard doses of oxycodone in treating pain problems. For the fentanyl study, we will investigate whether SJW treatment will interfere with the delivery of fentanyl to the brain and diminish it's effectiveness to relieve pain. There is evidence to suggest that SJW treatment may increase the activity of a transporter protein, named P-glycoprotein (Pgp), in the blood-brain barrier (BBB) that protects the brain from exposure to drugs and other dietary and environmental toxins.
NCT00092313 ↗ A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182) Completed Merck Sharp & Dohme Corp. Phase 3 2002-06-01 The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
NCT00092326 ↗ A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183) Completed Merck Sharp & Dohme Corp. Phase 3 2002-06-01 The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
NCT00158184 ↗ Prescription Opioid Effects in Abusers Versus Non-Abusers Completed National Institute on Drug Abuse (NIDA) Phase 2 2004-06-01 The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.
NCT00158184 ↗ Prescription Opioid Effects in Abusers Versus Non-Abusers Completed New York State Psychiatric Institute Phase 2 2004-06-01 The purpose of this study is to examine the abuse liability of oxycodone in individuals with, and without, a history of prescription opioid abuse.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Oxycodone

Condition Name

Condition Name for Oxycodone
Intervention Trials
Pain 93
Pain, Postoperative 56
Postoperative Pain 40
Healthy 29
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Condition MeSH

Condition MeSH for Oxycodone
Intervention Trials
Pain, Postoperative 133
Opioid-Related Disorders 32
Back Pain 30
Osteoarthritis 29
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Clinical Trial Locations for Oxycodone

Trials by Country

Trials by Country for Oxycodone
Location Trials
China 42
Canada 34
Finland 26
Italy 17
Poland 15
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Trials by US State

Trials by US State for Oxycodone
Location Trials
New York 75
California 64
Pennsylvania 55
Texas 52
Florida 42
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Clinical Trial Progress for Oxycodone

Clinical Trial Phase

Clinical Trial Phase for Oxycodone
Clinical Trial Phase Trials
Phase 4 199
Phase 3 119
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Oxycodone
Clinical Trial Phase Trials
Completed 318
Recruiting 78
Not yet recruiting 51
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Clinical Trial Sponsors for Oxycodone

Sponsor Name

Sponsor Name for Oxycodone
Sponsor Trials
Purdue Pharma LP 23
National Institute on Drug Abuse (NIDA) 19
Grünenthal GmbH 19
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Sponsor Type

Sponsor Type for Oxycodone
Sponsor Trials
Other 509
Industry 243
NIH 29
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Oxycodone: Clinical Trials, Market Analysis, and Projections

Overview of Oxycodone

Oxycodone is a potent opioid medication used to treat moderate to severe pain. It acts as an agonist on mu-type, kappa-type, and delta-type opioid receptors, providing effective pain relief for various conditions, including chronic pain, cancer pain, and post-surgical pain[1].

Clinical Trials Update

Ongoing and Recent Trials

The oxycodone market is supported by a robust pipeline of clinical trials. Here are some key updates:

  • Bariatric Surgery Pain Management: A clinical trial initiated by the Third People's Hospital of Chengdu in August 2022 is studying the use of oxycodone for pain treatment after bariatric surgery. This trial aims to evaluate the efficacy and safety of oxycodone in this specific patient population[3].
  • Cancer Pain Management: Short-acting oxycodone drugs have been increasingly prescribed for cancer pain management. For instance, a study published in the Cancer Journal in April 2021 indicated that short-acting oxycodone was prescribed for over 53.8% of patients with advanced cancer, highlighting its role in managing breakthrough pain[3].
  • Extended Release Formulations: Daiichi Sankyo launched a new generic formulation of oxycodone hydrochloride hydrate extended release tablets in 2019, which includes the narcotic antagonist naloxone to prevent abuse. This formulation is designed for sustained cancer pain treatment[4].

Trial Phases and Participation

Oxycodone has been involved in numerous clinical trials across various phases:

  • Phase 0: 18 trials
  • Phase 1: 146 trials
  • Phase 2: 60 trials
  • Phase 3: 126 trials
  • Phase 4: 171 trials[1].

These trials are crucial for understanding the drug's efficacy, safety, and optimal dosing regimens.

Market Analysis

Current Market Size and Growth

The global oxycodone market is experiencing significant growth driven by several factors:

  • Market Size: The oxycodone market was valued at USD 10.39 billion in 2024 and is projected to exceed USD 25.87 billion by 2037, growing at a CAGR of over 7.2% during the forecast period[2].
  • Segmentation: The market is segmented by route of administration, with the oral segment expected to hold the largest market share of about 45% by 2037. This dominance is due to the safer effects and higher retention of analgesic properties when taken orally[2].

Regional Market Insights

  • Asia Pacific: This region is projected to hold the largest market share of about 35% by 2037, driven by the growing aged population and increasing incidence of cancer. The region's elderly population is expected to reach 1.3 billion by 2050[2].
  • North America: This region is expected to hold the second largest market share, driven by the increasing number of cancer cases and the presence of large research institutes. Efficient reimbursement policies and rising economic conditions also contribute to market growth in this region[2].

End-User Segments

The market is also segmented by end-users, including hospitals, oncological centers, and drug stores. The demand from these segments is driven by the need for effective pain management solutions, particularly in cancer and chronic pain treatment[2].

Market Projections

Growth Drivers

Several factors are driving the growth of the oxycodone market:

  • Increasing Chronic Pain Prevalence: The rise in chronic pain diseases such as rheumatoid arthritis, cancer, lower back pain, and fibromyalgia is a significant driver. For example, the burden of rheumatoid arthritis is high, with over 400,000 people in the UK affected in 2021[3].
  • Post-Surgical Pain Management: Oxycodone is widely prescribed for post-surgical pain, contributing to market growth. Its use in managing pain after operations and surgeries is gaining momentum[5].
  • Parkinson’s Disease: The increasing prevalence of Parkinson’s disease, with about 1 million people in the US living with the condition, also drives the demand for oxycodone as a pain management solution[5].

Challenges and Regulatory Environment

Despite the growth drivers, the oxycodone market faces challenges:

  • Opioid Crisis and Regulatory Scrutiny: Concerns about misuse, addiction, and the opioid crisis have led to increased regulatory interventions. Changing prescribing practices and stringent regulations on drug approval are expected to influence market growth[5].
  • Adverse Effects and Abuse Prevention: The inclusion of narcotic antagonists like naloxone in extended release formulations is a step towards preventing abuse, but the risk of complications associated with oxycodone remains a concern[4].

Key Takeaways

  • Clinical Trials: Ongoing trials are focusing on the efficacy and safety of oxycodone in various pain management scenarios, including bariatric surgery and cancer pain.
  • Market Growth: The global oxycodone market is projected to grow significantly, driven by the increasing prevalence of chronic pain diseases and the need for effective pain management solutions.
  • Regional Insights: The Asia Pacific and North America regions are expected to be major contributors to market growth due to demographic and healthcare-related factors.
  • Challenges: The market faces challenges related to the opioid crisis and regulatory scrutiny, which may impact growth despite the rising demand for pain management solutions.

FAQs

What are the primary indications for oxycodone?

Oxycodone is primarily indicated for the treatment of moderate to severe pain, including acute and chronic pain, and is often used in combination with other medications like acetaminophen, ibuprofen, and naproxen[1].

How does oxycodone act on the body?

Oxycodone acts as an agonist on mu-type, kappa-type, and delta-type opioid receptors, affecting various bodily systems including the respiratory centre, cough centre, gastrointestinal tract, cardiovascular system, endocrine system, and immune system[1].

What are the potential side effects of oxycodone?

Common side effects include respiratory depression, constipation, muscle tone increase in the colon, histamine release leading to pruritis and flushing, and endocrine effects such as increased prolactin and decreased cortisol and testosterone levels[1].

How is the oxycodone market segmented?

The market is segmented by route of administration (oral, intravenous, others), end-users (hospitals, oncological centers, drug stores), and geographic regions (Asia Pacific, North America, etc.)[2].

What are the growth drivers for the oxycodone market?

Key drivers include the increasing prevalence of chronic pain diseases, post-surgical pain management needs, and the growing aged population, particularly in the Asia Pacific region[2][3][5].

Sources

  1. DrugBank: Oxycodone: Uses, Interactions, Mechanism of Action.
  2. ResearchNester: Oxycodone Market Size | Growth Analysis 2025-2037.
  3. Mordor Intelligence: Oxycodone Drugs Market Size & Share Analysis - Growth Trends.
  4. Daiichi Sankyo: Daiichi Sankyo Announces Launch of Oxycodone Extended Release Tablets.
  5. Future Market Insights: Oxycodone Market Size, Trends, Outlook & Forecast 2033.
Last updated: 2024-12-31

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