TRUISM
1 year ago
OVER 40% OF U.S. PHARMACIES REPORT NO BUPRENORPHINE IN STOCK, ACCORDING TO NEW PEER-REVIEWED STUDY FROM BICYCLE HEALTH PUBLISHED IN JAMA NETWORK OPEN
Bicycle Health-June 7, 2023
LINK
Florida pharmacies were least likely to have stock (37.1%), while Washington State pharmacies were most likely (83.9%)
Availability of buprenorphine for opioid use addiction in the United States by county
BOSTON, June 07, 2023 (GLOBE NEWSWIRE) -- Bicycle Health, the leading telehealth provider of integrated medical and behavioral health care for opioid use disorder (OUD) in the United States, announced new research published in JAMA Network Open that highlights the limitations of buprenorphine availability in pharmacies across America.
Medications for opioid use disorder (MOUD) – including buprenorphine – are widely considered to be a gold-standard of care for OUD. Adherence to MOUD has been shown to reduce ER visits, non-fatal drug overdoses, and healthcare costs. A 2019 study in the Journal of Substance Abuse Treatment found that 3.6% of patients who were adherent to MOUD experienced a nonfatal drug-related overdose, compared to 13.2% of MOUD patients who were non-adherent.
In spite of the success of MOUD with buprenorphine, access to the medication continues to be a challenge for patients and their providers. This peer-reviewed study showed that 42.1% of the nearly 5,300 unique retail pharmacies contacted by Bicycle Health’s team on behalf of its patients did not report buprenorphine stock at the time of the request. Importantly, access to buprenorphine stock varied heavily depending on the state the patient resided in or type of pharmacy queried.
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Key findings include:
* Pharmacy chains were more likely to have buprenorphine stock, with 61.6% of chain pharmacies reporting availability vs. 45.3% of independent pharmacies;
* Despite being more likely to have buprenorphine stock, there was still significant variability across chain pharmacy locations, based on chains where more than 40 locations reported stock;
* Over the course of this study, Bicycle Health made the most buprenorphine stock inquiries on behalf of patients to CVS and Walgreens locations. Buprenorphine availability was reported 59.7% and 70.3% of the time, respectively;
* Buprenorphine availability varied widely across the 32 states included in this study. Of states with more than 100 pharmacies queried, Florida locations were least likely to have stock (37.1%) and Washington State locations were most likely to have stock (83.9%);
* Over the course of this study, Bicycle Health made the most buprenorphine stock inquiries on behalf of patients in Florida and California. Buprenorphine availability was reported 37.1% and 46.8% of the time, respectively.
A full summary of the key outcomes and insights from the research are available online HERE in Bicycle Health’s resource center for strategic partners.
“Buprenorphine is a critical tool in the fight against the opioid overdose epidemic, but to be safely and effectively administered to patients with OUD, they must have consistent, timely, and convenient access,” said Bicycle Health’s Director of Research Scott G. Weiner, MD, MPH. “This study highlights how medication availability still represents a major barrier to care for many of Bicycle Health’s patients – as well as others seeking MOUD treatment across the United States.”
“At Bicycle Health, we talk a lot about defiant hope, which is essentially the need to stay upbeat and hopeful, even when it feels like we cannot help enough people, or that too few people care about our patients. Seeing this research published in JAMA is a ‘defiant hope day’ for me, because it means this issue will get the attention it deserves,” said Ankit Gupta, Bicycle Health’s Founder and CEO. “The responses we’ve gotten from some of the nation’s leading pharmacies have been inspiring, with their leaders pledging to partner with us to do better for patients long-term.”
Gupta continued, “This mission we’re on, to end opioid use disorder and increase access to treatment, needs an army of advocates working together if we’re going to overcome this epidemic. I’m grateful to see this research published and for the opportunities it’s creating for us to accelerate our mission in partnership with major pharmacies.”
"This data helps illustrate a major gap in our ability to care for patients with OUD, but the good news is it's a problem with a clear solution, “said Brian Clear, Bicycle Health’s Chief Medical Officer. “We've already had a positive response and commitment to improve stock rates from pharmacies."
The stigma associated with opioid use, the cost of in-person treatment options, and the lack of absence of telehealth treatment programs prior to the COVID public health emergency have all been consistent impediments in efforts to expand access to MOUD treatment with buprenorphine. As the Drug Enforcement Administration (DEA) looks to outline the regulations for prescribing via telehealth and continues setting stocking limits for buprenorphine, understanding the role these drugs play in addressing opioid use disorder is an important consideration. Bicycle Health’s evidence-based, clinically proven virtual care model is helping to increase access to these life-saving medications and address the opioid overdose epidemic head-on.
Bicycle Health is committed to working alongside America’s leading pharmacies, policymakers, and regulators to ensure patients across this country can safely and conveniently access the medications they need to maintain a healthy recovery.
About Bicycle Health
Bicycle Health is the leading telehealth provider of medications for opioid use disorder (MOUD) in the United States, offering an evidence-based clinical care model that includes FDA-approved Medications for Addiction Treatment (MAT), access to a highly-trained team of medical experts, therapy, a customized treatment plan, and peer support groups.
Bicycle Health’s mission is to address the country’s number one public health crisis by helping to reduce stigmas associated with opioid addiction and providing access to affordable, convenient, and confidential teleMOUD treatment for individuals in need. The company’s “whole person” approach to treatment encourages patients to focus on their life passions and goals, which has been shown to play a vital role in recovery. For more information, visit www.bicyclehealth.com.
TRUISM
TRUISM
1 year ago
ONLY 1 IN 4 ADOLESCENT TREATMENT FACILITIES OFFER BUPRENORPHINE FOR OPIOD USE DISORDER
JUNE 13, 2023
LINK
NIH-funded study indicates substantial need to expand access to evidence-based treatment among young people
Peer-Reviewed Publication
Only 1 in 4 residential addiction treatment facilities caring for U.S. adolescents under 18 years old offer buprenorphine, a medication used to treat opioid use disorder, according to a NEW STUDY Only 1 in 8 offer buprenorphine for ongoing treatment. These findings highlight a significant gap in access to evidence-based addiction treatment among young people. Published in JAMA, this study was supported by the National Institute on Drug Abuse (NIDA) and the National Center for Advancing Translational Sciences (NCATS), both part of the National Institutes of Health, and led by researchers at Oregon Health & Science University (OHSU).
There has been a dramatic rise in overdose deaths among young people aged 14-18 in recent years, likely driven by illicit counterfeit pills containing fentanyl. For those with opioid use disorder, medications are the most effective treatment options for preventing both return to opioid use and overdose deaths. Buprenorphine is the only medication for opioid use disorder that is approved by the U.S. Food and Drug Administration for use in people aged 16-18. Although buprenorphine is not approved for use among people under the age of 16 in the U.S., some professional medical societies recommend that buprenorphine be considered as a treatment option for opioid use disorder in younger people.
“It is tragic to see that young people with opioid use disorder are unable to access buprenorphine in most treatment facilities, despite this medication being the standard of care for people aged 16 and older” said Nora Volkow, M.D., director of NIDA. “Residential treatment facilities provide an opportunity to reach young people with a range of evidence-based supports at a pivotal time in their lives, and it is crucial that buprenorphine is made available as one of those options.”
Residential treatment facilities are part of the continuum of care for adolescents with opioid use disorder. However, little is known about specific evidence-based treatment options offered to young people at these facilities, including medications for opioid use disorder. To address this gap, researchers at OHSU sought to determine how many adolescent treatment centers in the U.S. were offering buprenorphine to treat opioid use disorder.
Using the FindTreatment.gov database, which is maintained by the Substance Abuse and Mental Health Services Administration (SAMSHA), the researchers identified a list of 354 centers across the U.S. that offered treatment for “substance use,” in a “residential/24-hour residential” service setting, and for “children/adolescents” (defined as people aged 17 and younger) to include in the analysis.
Researchers called these facilities to inquire about treatment and services offered as potential users of these services for a 16-year-old with a recent non-fatal fentanyl overdose. Between October and December 2022, the study team called the facilities in a random order and confirmed that 160 (45%) of these facilities provided residential treatment to patients under the age of 18.
Of the 160 residential addiction treatment facilities found to provide treatment to young patients, the researchers found that 39 facilities (24%) said that they offered buprenorphine to patients aged 16 or older, including through partnership with outside prescribing clinicians, though specific parameters for offering buprenorphine varied by site. For instance, only 20 facilities (12.5%) said that they offered buprenorphine for ongoing treatment. 12 facilities (7.5%) said that they offered buprenorphine to adolescents under 16 years of age.
Among the other 121 facilities that did not offer buprenorphine to adolescents or weren’t sure, 57 (47%) indicated that adolescents prescribed buprenorphine by their own clinician could stay on it at least temporarily, although some stated they would discontinue it before discharge. And 27 (22%) required that adolescents were not taking buprenorphine in order to be admitted for residential treatment.
Based on these findings, the average person would need to call nine facilities on the SAMHSA list to find one that offered buprenorphine. To find one for an adolescent under 16, they would need to call 29 facilities.
“These residential treatment centers see some of the most vulnerable adolescents in our communities,” said lead author Caroline King, M.D., Ph.D., who completed this research as a student in the OHSU School of Medicine. “We need to support these centers to make evidence-based care the norm.”
“Buprenorphine is the one medication that’s approved for use in adolescents, and it’s underused in facilities taking care of kids with the most severe opioid use disorder,” said co-author Todd Korthuis, M.D., M.P.H., head of addiction medicine at OHSU. “It’s a big issue, but it’s something that we can change by supporting these treatment centers with education and technical assistance about buprenorphine, better funding to staff these centers, and by letting the public know that buprenorphine is necessary treatment in healing brains.”
TRUISM
TRUISM
1 year ago
Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder
Article/PR
BRIXADI is the first and only long-acting buprenorphine injectable with both weekly and monthly doses.
Patients currently on a transmucosal buprenorphine-containing product can be switched to an equivalent dose of BRIXADI Weekly or Monthly.
BRIXADI will be available through a restricted distribution program via the BRIXADI REMS Program and is administered only by a healthcare professional.
PLYMOUTH MEETING, Pa., May 23, 2023 /PRNewswire/ -- Braeburn announces that the U.S. Food and Drug Administration (FDA) has approved BRIXADI (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product.
BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support. BRIXADI is to be administered only by healthcare providers in a healthcare setting and will be available in the U.S. in September 2023.
BRIXADI is the first and only weekly and monthly subcutaneous injection for moderate to severe OUD and is the only buprenorphine injectable that utilizes FluidCrystal®* Injection Depot Technology. Patients currently being treated with oral buprenorphine-containing products can be switched to equivalent doses of BRIXADI Weekly or BRIXADI Monthly in accordance with the Prescribing Information for BRIXADI.
"Today's FDA approval of BRIXADI is a significant step forward in the fight against OUD," said Mike Derkacz, President and CEO of Braeburn. "Over the last three years the US experienced a significant increase in opioid overdoses in part related to the economic and social upheaval that negatively impacted all of us, especially people with opioid use disorder and people in recovery.
Additional medication options for opioid use disorder will support healthcare providers in addressing the needs of their patients with opioid use disorder."
Due to the risk of serious harm resulting from accidental intravenous (IV) administration, BRIXADI has a Boxed Warning and will be made available through a restricted distribution program called the BRIXADI Risk Evaluation and Mitigation Strategy (REMS). Healthcare settings and pharmacies that order and dispense BRIXADI must be certified in this program and comply with the REMS requirements. Information on the BRIXADI REMS program will be available at www.BRIXADIREMS.com.
BRIXADI is the only injectable buprenorphine studied against sublingual buprenorphine/naloxone (SL BPN/NX) in a 24-week Phase 3, double-blind study, which randomized 428 adults with moderate to severe OUD. The trial enrolled patients representative of the real-world population, including patients that injected opioids (52%), patients that primarily used heroin (71%), patients with evidence of fentanyl use (26%) and patients using nonopioid substances at screening (71%).
In this pivotal Phase 3 efficacy and safety trial, weekly and monthly BRIXADI met the primary endpoint of non-inferiority for responder rate versus daily SL BPN/NX (16.9% vs. 14.0%, respectively; p<0.001). Additionally, BRIXADI demonstrated superiority to SL BPN/NX based on the cumulative distribution function (CDF) of the percentage of negative opioid assessments from week 4 through week 24 (p=0.004; secondary endpoint).
"A weekly and monthly buprenorphine injection with different dose options can align with clinical practice and patient care needs," said Dr. Michelle Lofwall, Professor of Behavioral Science and Psychiatry at the University of Kentucky Center on Drug and Alcohol Research and Primary Investigator in the Phase 3 efficacy and safety study. "Some patients need help with taking their medication as prescribed, some prefer not taking a daily medication or visiting a pharmacy to pick up their medication, so having a weekly and monthly option that provides buprenorphine over one week or one month could benefit patients, their loved ones and the treatment providers."
The safety profile of BRIXADI was consistent with the known systemic safety profile of oral buprenorphine with the exception of mild-to-moderate injection-site reactions. The most common adverse reactions included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and urinary tract infections.
BRIXADI is formulated using FluidCrystal® Injection Depot Technology, allowing for a low volume pre-filled syringe. Upon injection and contact with fluids in the tissue, the solution transforms into a nanostructured liquid-crystalline gel allowing for a slow release of buprenorphine at a steady rate over a one-week or one-month period. BRIXADI is delivered with a 23-gauge needle and may be administered in the buttock, thigh, stomach (abdomen) or upper arm.** BRIXADI does not require refrigeration.
*FluidCrystal® is a trademark owned by Camurus and used under license by Braeburn.
**In patients who are not currently receiving buprenorphine treatment, for BRIXADI Weekly, the upper arm site should only be used after steady state has been achieved (4 weeks).
Always felt Braeburn wanted to bur Probuphine, in order to shelve it.
What's in the dark, surfaces to the light eventually.
TRUISM
TRUISM
2 years ago
Activist Investing Nominates Slate Of Highly Qualified Director Candidates For Election To the Board Of Directors Of Titan Pharmaceuticals At Upcoming Special Meeting Of Stockholders
PR ANNOUNCEMENT
July 11 2022 - 08:00AM
GlobeNewswire Inc.
David E. Lazar, Chief Executive Officer of Activist Investing LLC (together with its affiliates, “Activist Investing” or “we”), one of the largest stockholders of Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) (“Titan” or the “Company”) with 25.2% of the Company’s outstanding shares, today issued the following statement:
“We have submitted a request for the Company to hold a special meeting of the Company’s stockholders (the “Special Meeting”) to expand the size of Titan’s Board of Directors (the “Board”) by six (6) directors and to elect our slate of six (6) highly qualified professionals, Avraham Ben-Tzvi, Peter L. Chasey, Eric Greenberg, David E. Lazar, Matthew C. McMurdo and David Natan (collectively, the “Nominees”), to fill the resulting Board vacancies in order to progress the Company’s previously announced review of strategic alternatives.
The Nominees collectively possess decades of experience in strategic turnarounds, deal structuring, corporate governance, investment management, accounting, finance and corporate law, which we believe will be extremely additive to the Company and its ability to unlock significant stockholder value through a strategic transaction.
As disclosed by the Company, the Special Meeting will be held on August 2, 2022 with a corresponding record date of July 22, 2022 to determine the stockholders entitled to vote on our proposals at the Special Meeting. We look forward to communicating further with fellow stockholders in the coming weeks and will be filing proxy materials to solicit votes to materially reconstitute the Board at the Special Meeting with our Nominees.”
Biographies of Activist Investing’s nominees are included below:
We believe that Mr. Ben-Tzvi’s extensive legal experience and knowledge in the field of civil-commercial law, and in corporate and securities law, and his previous public company and commercial business experience will make him a valuable addition to the Board. Avraham Ben-Tzvi, Adv. is the Founder of ABZ Law Office, a boutique Israeli law firm specializing in outsourced general counsel services for publicly traded as well as private companies and corporations, Investments & Securities Laws, Commercial Law & Contracts and various civil law matters, which he established in January 2017. Mr. Ben-Tzvi served as Chief Legal Officer and General Counsel of Purple Biotech Ltd. (formerly Kitov Pharma Ltd.), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, from November 2015 until April 2020.
Prior to that, Mr. Ben-Tzvi served as General Counsel and secretary at Medigus Ltd., a minimally invasive endosurgical tools medical device and miniaturized imaging equipment company, from April 2014 until November 2015. Mr. Ben-Tzvi is a member of the Israel Bar Association, and is also licensed as a Notary by the Israeli Ministry of Justice. Prior to that he served as an attorney at one of Israel’s leading international law firms where, amongst other corporate and commercial work, he advised companies and underwriters on various offerings by Israeli companies listing in US and on various SEC related filings.
Prior to becoming a lawyer, Mr. Ben-Tzvi worked in a number of business development, corporate finance and banking roles at companies in the financial services, lithium battery manufacturing and software development industries. Mr. Ben-Tzvi holds a B.A., magna cum laude, in Economics from Yeshiva University in New York and an LLB, magna cum laude with Honors, in from Sha'arei Mishpat College of Law in Hod HaSharon, Israel.
We believe that Mr. Chasey’s commercial law expertise, coupled with his experience leading his own law firm, will make him a valuable addition to the Board. Peter L. Chasey, Esq. serves as the Owner of Chasey Law Offices, a law practice specializing in personal litigation, business litigation and commercial law, since founding the practice in 2005. Earlier in his career, Mr. Chasey served as staff counsel for one of the largest insurance companies in the world defending general claims against insured businesses and also served as a land surveyor. Mr. Chasey holds a B.S. in Political Science and Government from the University of San Diego and a J.D. from the University of San Diego School of Law.
We believe that Mr. Greenberg’s more than 40 years’ experience in trading, developing strategies, and portfolio management and public markets experience in the microcap sector will make him a valuable addition to the Board. Eric Greenberg has over 40 years of capital markets experience. As a trader and portfolio manager at hedge funds, his areas of expertise included the development of trading strategies, portfolio management and deal structuring.
Mr. Greenberg was Co-Founder of Blink Charging Co., a leader in the EV charging infrastructure industry. In addition, Mr. Greenberg provides investor relation and digital marketing services for companies across a variety of industries, such as life sciences, fintech, internet platforms and others. Mr. Greenberg holds a B.B.A in Finance from Baruch College and an M.B.A. in Finance from Baruch College Zicklin School of Business.
We believe Mr. Lazar’s position as a significant investor in the Company and his diverse knowledge of financial, legal and operations management, public company management, accounting, audit preparation, due diligence reviews and SEC regulations will make him a valuable addition to the Board. David E. Lazar has served as the Chief Executive Officer of Custodian Ventures LLC, a company which specializes in assisting distressed public companies through custodianship, since February 2018, and Activist Investing LLC, an actively managed investment fund, since March 2018.
Previously, Mr. Lazar served as Managing Partner at Zenith Partners International Inc., a boutique consulting firm, from July 2012 to April 2018. In his role as Chief Executive Officer of Custodian Ventures LLC, Mr. Lazar has successfully served as a custodian to numerous public companies across a wide range of industries. Mr. Lazar currently serves as an Advisor to PROMAX Investments LLC, a position he has held since July 2022, and as an Ambassador at Large for the Arab African Council for Integration and Development, since March 2022.
We believe that Mr. McMurdo’s extensive experience in corporate and securities law and advising many public companies with federal securities law will make him a valuable addition to the Board. Matthew C. McMurdo, Esq. currently serves as Managing Member of McMurdo Law Group, LLC, a corporate and securities law practice, since 2010.
Previously, Mr. McMurdo was a Partner at Nannarone & McMurdo, LLP, a boutique law firm, from 2008 to 2010. In addition, Mr. McMurdo served as General Counsel of Berkley Asset Management LLC, the general partner of a real estate fund focused on opportunistic and distressed real estate assets, from 2011 to 2013. Mr. McMurdo holds a B.S. in Finance from Lehigh University and a J.D., cum laude, from Benjamin N. Cardozo School of Law.
We believe Mr. Natan’s reputation as a seasoned business executive and his extensive experience as a director of technology-enabled public companies will make him a valuable addition to the Board. David Natan currently serves as President and Chief Executive Officer of Natan & Associates, LLC, a consulting firm offering chief financial officer services to public and private companies in a variety of industries, since 2007. In addition, Mr. Natan currently serves as Executive Vice President and Chief Financial Officer for Airborne Motorworks, Inc., a privately-held aerospace transportation company, since April 2020.
From February 2010 to May 2020, Mr. Natan served as Chief Executive Officer of ForceField Energy, Inc., a company focused on the solar industry and LED lighting products. From February 2002 to November 2007, Mr. Natan served as Executive Vice President of Reporting and Chief Financial Officer of PharmaNet Development Group, Inc., a drug development services company, and, from June 1995 to February 2002, as Chief Financial Officer and Vice President of Global Technovations, Inc., a manufacturer and marketer of oil analysis instruments and speakers and speaker components.
Prior to that, Mr. Natan served in various roles of increasing responsibility with Deloitte & Touche LLP, a global consulting firm. Mr. Natan currently serves as a member of the Board of Directors and Chair of the Audit Committee of Global Diversified Marketing Group, Inc., a manufacturer, marketer and distributor of food and snack products, since February 2021 and serves as a member of the Board of Directors and Chair of the Audit Committee of Sunshine Biopharma, Inc., a pharmaceutical and nutritional supplement company, since February 2022.
Previously, Mr. Natan served as Chairman of the Board of Directors of ForceField Energy, Inc., from April 2015 to May 2020, and as a member of the Board of Directors of Global Technovations, Inc., from December 1999 to December 2001. Mr. Natan holds a B.A. in Economics from Boston University.
About Activist Investing
Activist Investing LLC is an investment fund specializing in reverse merger and other event-driven opportunities. Its Chief Executive Officer, David E. Lazar, brings domestic and international experience in operations, accounting, audit preparation, due diligence, capital restructuring, debt financing, and mergers and acquisitions.
Certain Information Concerning the Participants
Activist Investing LLC (“Activist Investing”), together with the other participants named herein (collectively, “Activist”), intends to file a preliminary proxy statement and an accompanying WHITE proxy card with the Securities and Exchange Commission (“SEC”) to be used to solicit votes for the election of its slate of highly-qualified director nominees and in connection with the related proposals to be acted upon by stockholders at the upcoming special meeting of stockholders of Titan Pharmaceuticals, Inc., a Delaware corporation (the “Company”).
ACTIVIST STRONGLY ADVISES ALL STOCKHOLDERS OF THE COMPANY TO READ THE PROXY STATEMENT AND OTHER PROXY MATERIALS, INCLUDING A WHITE PROXY CARD, AS THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. SUCH PROXY MATERIALS WILL BE AVAILABLE AT NO CHARGE ON THE SEC'S WEB SITE AT HTTP://WWW.SEC.GOV. IN ADDITION, THE PARTICIPANTS IN THIS PROXY SOLICITATION WILL PROVIDE COPIES OF THE PROXY STATEMENT WITHOUT CHARGE, WHEN AVAILABLE, UPON REQUEST. REQUESTS FOR COPIES SHOULD BE DIRECTED TO ACTIVIST INVESTING.
The participants in the proxy solicitation are expected to be Activist Investing, David E. Lazar, Avraham Ben-Tzvi, Peter L. Chasey, Eric Greenberg, Matthew C. McMurdo and David Natan (collectively, the “Participants”).
As of the date hereof, Activist Investing directly beneficially owns 359,066 shares of Common Stock, par value $0.001 per share, of the Company (the “Common Stock”). As of the date hereof,
Mr. Lazar directly beneficially owns 3,331,402 shares of Common Stock. Mr. Lazar, as the sole member and Chief Executive Officer of Activist Investing, may be deemed to beneficially own the 359,066 shares of Common Stock directly beneficially owned by Activist Investing. As of the date hereof, none of Messrs. Ben-Tzvi, Chasey, Greenberg, McMurdo or Natan beneficially owns any shares of Common Stock.
Investor Contact Information:
David E. Lazar
David@activistinvestingllc.com
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