History of EDTA Chelation Therapy - Schachter Center for ...
History of EDTA Chelation Therapy ACAM Chelation Workshop November 20, 2013-Palm Springs CA Michael B Schachter MD, CNS Schachter Center for Complementary Medicine 2 Executive Boulevard; Suite 202 Suffern, New York 10901 Phone: 845-368-4700; FAX: 845-368-4727 Website: www.schachtercenter.com E-Mail: [email protected] Special thanks to Terry Chappell MD & John Trowbridge MD for creating a timeline for EDTA chelation therapy MBS-ACAM Chelation Workshops 9-20-13 1 Disclaimer According to federal law, the Federal Food & Drug Administration is responsible for
determining claims for any substance used to treat, prevent or mitigate any disease or condition, such as cancer No such claims are being made during this lecture Information from this lecture is purely for informational purposes and no claims are being made MBS ACAM 11-13 Salvestrols 2 Conflicts of Interests At our Center, we do have a dispensary from which we offer patients the option of buying supplements that are recommended. They are free to buy most of these supplements elsewhere, such as at a Health Food Store or on the Internet Among the supplements, we recommend are
Salvestrols, which are discussed in this lecture Patients may also purchase these supplements online MBS ACAM 11-13 Salvestrols 3 Chelation & Chelating Agents Greek word chele means claw Organic molecule binds to a cation in pincer-like fashion Forms a heterocyclic ring structure (1893-Werner) Chelated minerals-everywhere Hemoglobin-Iron Chelate Chlorophyll-Magnesium Chelate MBS-ACAM Chelation Workshops 9-20-13
Hemoglobin Chelation Therapy Accepted Treatment for 2 forms of EDTA: Removal of toxic minerals like lead, or cadmium from the body, using calcium disodium EDTA Treatment of hypercalcemia with disodium EDTA Controversial Treatment: Use of disodium EDTA to treat cardiovascular disease Discovered in the 1950s to benefit patients with coronary artery disease by Norman Clarke and associates MBS-ACAM Chelation Workshops 9-20-13 5 Textile Industry Needs to Remove
Calcium During Dying Process-1930s Synthesis of polyaminocarboxylic acids Disodium EDTA was one of these Patent granted in Germany in 1935 MBS-ACAM Chelation Workshops 9-20-13 6 EDTA & Calcium Homeostasis: Early 1940s Martin Rubin PhD & Frederick Bersworth involved with getting a patent for disodium EDTA in USA Laboratory use as an anticoagulant; still used today Purple-top tubes Rubin collected the worlds literature on EDTA & helped get FDA approval for its use in lead poisoning (CaEDTA) & hypercalcemia (disodium EDTA)
MBS-ACAM Chelation Workshops 9-20-13 7 EDTA for Lead Poisoning-1950s; Improvement in CV Disease Norman Clarke Sr. & Albert Boyle separately reported on heart disease improvement in many patients being treated for lead poisoning with disodium EDTA therapy Many of these patients suffered from lead toxicity as a result of exposure in auto industry Clark reasoned that since calcium was involved in atherosclerosis, perhaps EDTA would help coronary atherosclerosis MBS-ACAM Chelation Workshops 9-20-13 8
Chelation for Coronary Artery Disease Clark et al: 1956 and 1960 Clark et al: 1956 20 patients16 unstable angina Complete relief of angina in 17 16 asymptomatic at 21 months ECG normalized in 33% Clark et al: 1960
76 patients33 post MI 87% of patients had 90% relief of angina 2 year mortality half that expected 20% had recurrent angina relieved with additional EDTA infusions MBS-ACAM Chelation Workshops 9-20-13 9 Book: Metal Binding in Medicine Marvin Seven, Editor-1960 Book contained papers on chelation therapy from two major symposia held around that time Dr. Seven was associated with the NIH and had great interest in chelation Was killed in an auto accident in 1961 First setback for chelation therapy
MBS-ACAM Chelation Workshops 9-20-13 10 Dr. Kitchell & Meltzer: 2nd Setback for EDTA Chelation Therapy Cardiology specialists at Presbyterian Hospital in Philadelphia From 1959 to 1963, published series of studies on EDTA for heart disease Early papers were positive, though they noted that positive results often delayed after the onset of treatment 1963: Reappraisal article published in the American Journal of Cardiology Results were positive; but conclusions were negative Conventional physicians gave up on chelation therapy following publication of the Reappraisal article
MBS-ACAM Chelation Workshops 9-20-13 11 Summary of Kitchell & Meltzer 4 Year Experience as Presented by Cranton 38 total patients29 post MI 71% improvement of disabling angina 45% sustained improvement lasting up to 46 months without follow-up treatments Critique of article by Cranton & Frackelton ignored Rumors that pressure on Kitchell & Meltzer to publish the Reappraisal article Academics and conventional physician turned away from EDTA chelation therapy (2nd setback) MBS-ACAM Chelation Workshops 9-20-13 12
Ray Evers MD-Chelating Physician in Alabama (1960s and 70s) Ray Evers MD Used EDTA extensively to treat all kinds of degenerative diseases and particularly cardiovascular diseases He sometimes treated patients daily with this treatment Although anecdotal reports were generally positive, some reports of severe adverse effects Dr. Evers won a precedent setting case with the FDA supporting a physicians right to treat patients with a drug (EDTA) for conditions not approved by the FDA (Off-label prescriptions) 1978 MBS-ACAM Chelation Workshops 9-20-13 13 Carlos Lamar MD-Series of Positive Case
Reports using EDTA Therapy-1960s Carefully documented reports showing benefits for cardiovascular disease and diabetes Documented cases of preventing amputation with gangrene of the foot Recommended supplements along with EDTA chelation therapy MBS-ACAM Chelation Workshops 9-20-13 14 Abbotts Patent for Disodium EDTA Expires in 1969-3rd Setback When the patent for Edetate expired in 1969, economic motivation to promote disodium EDTA for cardiovascular disease ceased 3rd Setback for EDTA chelation therapy, the
others being: Death of Marvin Seven Kitchell & Meltzer negative conclusions of their studies MBS-ACAM Chelation Workshops 9-20-13 15 American Academy of Medical Preventics (AAMP) formed 1972 Harold Harper, Gary Gordon, Ross Gordon Bob Vance and Dave Roberts formed this organization to study, educate and promote EDTA chelation therapy for cardiovascular disease Later name changed to American College of Advancement in Medicine (ACAM) with an emphasis on broadening its scope (1985) AAMP or later ACAM presented workshops
and conferences twice a year, including training in EDTA chelation therapy MBS-ACAM Chelation Workshops 9-20-13 16 Linus Pauling PhD-Champion of AAMP Linus Pauling concept of orthomolecular medicine supports AAMP He is made lifetime member of AAMP in 1975 Nutrition and supplements utilized by AAMP physicians to help their patients MBS-ACAM Chelation Workshops 9-20-13 17
Scientific Basis of EDTA Chelation Therapy: End of 1970 1976: Garry Gordon & Robert Vance: Paper on possible mechanisms of EDTA chelation therapy 1979-Dr. Bruce HalsteadExplores the molecular basis and mechanisms of the effects of EDTA (Updated by Dr. Ted Rozema in 1997) MBS-ACAM Chelation Workshops 9-20-13 18 Richard Casdorph MD-CardiologistArticles of benefits of EDTA-Early 1980s Paper: EDTA chelation therapy, efficacy in arteriosclerotic heart
disease J Holistic Medicine 1981: Showed improvement in ejection fractions of the heart with chelation Paper: EDTA chelation therapy II, efficacy in brain disorders J of Holistic Medicine, 1981: Improvement in cerebral circulation with EDTA chelation MBS-ACAM Chelation Workshops 9-20-13 19 McDonagh, Rudolph & Cheraskin: Numerous Clinical Studies 1980s McDonagh & Rudolph: Large chelation practice in Kansas City, Missouri Published 30 clinical articles on the use of EDTA chelation therapy; sometimes with Emanuel Cheraskin MD, DMS; all articles positive
Many studies published in J. Holistic Medicine Some of the studies: positive effects of EDTA chelation therapy on: Lipid metabolism Carotid artery blood flow Lung function Showed no adverse effect on bone density or renal function MBS-ACAM Chelation Workshops 9-20-13 Ed McDonagh DO Charlie Rudolph DO, PhD Emanuel Cheraskin MD,DMD 20 Controversy and Other Organizations Formed in the 1980s
AMA called for studies to see if EDTA chelation therapy worked Conventional cardiologists wrote several editorials critical of it American Board of Chelation Therapy (ABCT) formed to test and certify doctors giving chelation therapy (written and oral exams) in 1982 (offshoot of AAMP); in 2003 replaced by the American Board of Clinical Metal Toxicology (IBCMT) Great Lakes College of Clinical Medicine formed in 1983 to teach & research chelation and other cutting edge therapies; later called the International College of Integrative Medicine (ICIM) MBS-ACAM Chelation Workshops 9-20-13 21 Elmer Cranton MD-Book: Bypassing Bypass 1984 In the 1980s coronary artery bypass surgery (CABG) was becoming more popular
Elmer Cranton MD was Harvard Medical School Graduate-1964 He was the 6th president of ACAM For many years, practiced in Virginia and then later in the state of Washington; Retired from active practice 2007, but continues to work on his website 1984: Book Bypassing Bypass published; written for the intelligent layman very well referenced; Suggests that EDTA chelation therapy is safer and more effective that CABG for coronary artery disease 2001: Book expanded and updated MBS-ACAM Chelation Workshops 9-20-13 1984 2001 22
Frackelton & Cranton: EDTA and Free Radical Control James Frackelton MD-Died in 2012Practiced EDTA chelation in Westlake Ohio with Derrick Lonsdale MD Frackelton was ACAM-7th President 1984: Cranton & Frackelton published a landmark paper proposing that free radical control was the primary mechanism for benefits of EDTA chelation therapy Cranton was ACAMs 6th President MBS-ACAM Chelation Workshops 9-20-13 23 Walter Reed Army Hospital Study: Not Completed In 1986, after complex negotiations, Walter Reed
Army Hospital agreed to do a randomized, doubleblind placebo controlled study involving EDTAs effects on intermittent claudication Study was halted half way through, allegedly because investigators were called to serve in the Gulf War and didnt return to complete the study Following the war, a pharmaceutical company agreed to fund the entire project, but then reneged after hiring a long time opponent of chelation therapy as their new medical director. MBS-ACAM Chelation Workshops 9-20-13 24 Efrain Olszewer MD & James P Carter MD, DrPH-EDTA Chelation Studies Ephraim Olszewer MD is from Brazil; published numerous books and articles on nutrition and EDTA
James P Carter MD, DrPH: Was on faculty of Tulane University School of Public Health; practices in near New Orleans 1988-Published study in Medical Hypothesis: Retrospective study involving vascular disease: coronary, peripheral and cerebrovascular Patients receiving EDTA chelation therapy showed great benefits: No controls Small double-blind study 1990-benefits for peripheral vascular disease MBS-ACAM Chelation Workshops 9-20-13 25 Journal of Advancement in Medicine Established 1988 Journal printed a number of studies on controversial topics, especially EDTA chelation therapy
Volume 2; Numbers 1 and 2 is shown here Reprinted many of the articles on EDTA chelation therapy previously discussed If EDTA Chelation Therapy is so Good, Why Is It Not More Widely Accepted? James P Carter MD, DrPh MBS-ACAM Chelation Workshops 9-20-13 26 Journal of the Advancement in Medicine: Two Editors First Editor was Elmer Cranton for a only one year Second & only other editor was Derrick Lonsdale, partner of James
Frackelton in Ohio; for 10 years Frustrated because always had trouble getting sufficient articles Authors were reluctance to submit because not on Index Medicus Many good ideas not seen by many practitioners Ceased publication in 1999 MBS-ACAM Chelation Workshops 9-20-13 Elmer Cranton Derrick Lonsdale 27 Popular Books on EDTA Chelation Therapy Several popular books advocating use of EDTA chelation therapy: Writers passionate
Arline Brecher: Toured the country & lectured Podiatrist and medical journalist Morton Walker also wrote a popular book Chelation patients came from other patients or from these books: Not from MDs Most physicians began to chelate because member of family did well; rare to find MD to turn away from it after starting to treat MBS-ACAM Chelation Workshops 9-20-13 28 Racketeering in Medicine by James P Carter MD, D.Ph. Dr. Carter elaborates on his paper as to why EDTA chelation therapy is not
more accepted Discussed medical politics Turf struggles between medical specialties & factions in health care professions Book published in 1992 MBS-ACAM Chelation Workshops 9-20-13 29 Early 1990s: Three Small Conventional Studies Critical of EDTA Chelation Therapy All published in major journals These articles were severely criticized by advocates of EDTA chelation therapy for methodological issues & conclusions not justified by data Studies allegedly double-blinded with placebo, but there were questions about this as well
All concluded no evidence of benefit Basically supported the quackbusters & opponents of chelation MBS-ACAM Chelation Workshops 9-20-13 30 Positive EDTA Chelation Therapy from Denmark in 1992 Retrospective study of 470 patients who received EDTA chelation therapy in Denmark Vast majority-significant improvement Of 65 on waiting list for CABG, only 7 were given the procedure during or after chelation therapy Of 27 scheduled for amputation due to severe peripheral vascular disease, only 3 needed the surgery Study done over 6 years & chelation
treatment saved the Danish Government about 3 million dollars MBS-ACAM Chelation Workshops 9-20-13 Claus Hancke MD & Flytlie 31 Meta-Analysis on EDTA Chelation Therapy Studies Chappell & Stahl published a meta-analysis study in 1993 involving EDTA therapy for CV disease They Identified 40 published studies and 19 met the criteria they had established More than 22,000 patients were included A high correlation coefficient of 0.88 was established for the statement that EDTA
chelation therapy was helpful to patients with cardiovascular disease 88% of the patients showed improvement with objective testing MBS-ACAM Chelation Workshops 9-20-13 L. Terry Chappell MD 32 Questions from the Heart by Terry Chappell MD-1995 Meta-analysis of published studies in
appendix To avoid publication bias, Dr. Chappell conducted another Meta-analysis from case reports on patients not included in published studies Results the same Also, reprinted in appendix of this book 100 Questions patients might ask about chelation with answers-ideal for patient considering chelation MBS-ACAM Chelation Workshops 9-20-13 33 Protocol for EDTA Chelation Therapy & Historical Overview-1996 Overview, Historical Background and Current Status of EDTA Chelation Therapy for Cardiovascular Disease in
1996 by Michael Schachter MD (J. of Advancement in Medicine; Volume 9, Number 3) Protocol being used in the EDTA chelation workshops was refined & published in the Journal by Ted Rozema in 1997 (J. Advancement in Medicine; Volume 10, Number 1) MBS-ACAM Chelation Workshops 9-20-13 34 Quackbusters: See www.quackwatch.com Organization that was critical of any practice outside of conventional medicine, including chelation therapy
Long history of attacks on homeopathy, naturopathy, chiropractic, others Encouraged action of Medical Boards to discipline chelating physicians Encouraged patients to sue MBS-ACAM Chelation Workshops 9-20-13 Victor Herbert MD-Deceased Stephen Barrett MD 35 Quackbuster Activity Against Chelation Therapy Infiltrated the Federation of Medical Boards & encouraged disciplinary actions against chelating physicians all over the USA
ACAM has a legal team now that helps to protect members California: Attempted to make EDTA chelation therapy illegal; ACAM representatives testified & the proposed law was defeated (Late 1990s) MBS-ACAM Chelation Workshops 9-20-13 36 Federal Trade Commission (FTC) Fiasco; Late 1990s FTC brought legal action against ACAM for a statement in its brochure that EDTA chelation therapy was safe & effective for atherosclerosis ACAM submitted 100 articles and spent over a million dollars in legal fees; BUT FTC insisted that randomized double-blind studies had to be done for such a claim ACAM gave up & agreed not to make that
statement MBS-ACAM Chelation Workshops 9-20-13 37 Stephen Olmsteads Monograph on EDTA Chelation Therapy Late 1990s-Stephen Olmstead MD, cardiologist wrote a scholarly 100 page monograph on the chemistry, mechanisms and scientific evidence for EDTA chelation therapy Said preponderance evidence suggests EDTA chelation beneficial for peripheral and possibly cardio vascular disease This document was distributed to every medical school library in the United States
MBS-ACAM Chelation Workshops 9-20-13 Stephen Olmstead MD 38 Congressman Dan Burton Pressures Govt Agencies to Study Chelation Therapy-1999 Congress Burton, Chairman of the Congressional Oversight Committee held hearings about EDTA chelation therapy Testimony from NIH representatives Testimony from prominent chelating physicians like Terry Chappell & Ted Rozema; Olmstead monograph offered Conclusion was that a large scale study was clearly indicated http://www.chelationtherapyonline.com/ articles/p12.htm Subsequently, the NIH sent out a call for
proposals MBS-ACAM Chelation Workshops 9-20-13 Congressman Daniel Burton 39 NIH Trial to Assess Chelation Therapy (TACT) The first proposal to the NIH was rejected; but the 2nd one was accepted Gervasio (Tony) A. Lamas MD, a prominent cardiologist researcher at the University of Miami (now part of Columbia University) was chosen to conduct trial University medical schools and chelation therapists agreed to Gervasio (Tony) Lamas MD
participate MBS-ACAM Chelation Workshops 9-20-13 40 TACT: Sponsors & Type of Study Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Collaborator: National Center for Complementary and Alternative Medicin e (NCCAM ) 30 million dollar study > 120 sites; our office participated in the trial; patients received a total of 40 infusions (30 weekly & 10 monthly) Randomized double-blind, placebo controlled 5-year study (turned out to be much longer); patients followed for 3 years after completion of treatment Adverse events in patients receiving EDTA or placebo were monitored carefully
MBS-ACAM Chelation Workshops 9-20-13 41 TACT Hurdles Many cardiologists discouraged participation Enrollment proceeded slowly Quackbusters complained and said trial should be stopped immediately & the trial was delayed temporarily Same group convinced a reporter in Chicago Tribune to write a negative article even though results not yet released Around this time, an autistic child was given disodium EDTA as a push and died (reported by CDC); NEVER GIVE DISODIUM EDTA AS A PUSH as it may cause hypocalcemia & cardiac arrhythmias MBS-ACAM Chelation Workshops 9-20-13 42
TACT Study Vindicated, Resumes & is Completed Complete investigation resulted in conclusion that nothing wrong with TACT and it resumed > 1700 patients enrolled in study Results presented at AHA meeting on Nov 4, 2012 Results: EDTA treatment group showed statistically significant benefits and the paper was published in JAMA on March 27, 2013 Statistically significant subgroups involved diabetics and the location of the coronary artery disease, though other parameters positive in right direction MBS-ACAM Chelation Workshops 9-20-13 43 Conservative Conclusions of Gervasio (Tony) Lamas MD
EDTA chelation therapy appears to be safe The treatment in the study (EDTA, ascorbate & other components) showed some evidence of benefit for post-MI patients already on evidence-based therapy The findings were unexpected and additional research is needed to confirm or refute our results and explore possible mechanisms of therapy TACT does not constitute evidence to recommend the clinical application of chelation therapy MBS-ACAM Chelation Workshops 9-20-13 44 EDTA Chelation Therapy Treatment Controversy Rages On Quackbusters, some conventional medicine sources and mainstream media begin to spin TACT study in a negative way, while others are positive
Major discussions since the AHA presentation and after the JAMA article Medical professionals who advocate EDTA chelation therapy generally refrain from making any claims publically. MBS-ACAM Chelation Workshops 9-20-13 45 Chelation Therapy: What To Do With Inconvenient Evidence? Forbes Magazine Harlan Krumholz MD: Professor of cardiology, epidemiology, and public health at Yale and director of the Center for Outcomes Research and Evaluation Testified against Merck in Vioxx and showed excessive diagnostic radiation Harlan Krumholz MD causes cancer; but still mainstream Forbes Magazine article on TACT: However, this study
has opened my mind to the possibility that there may be something more to this therapy than I originally thought Conflicts of Interest: No pharmaceutical companies MBS-ACAM Chelation Workshops 9-20-13 46 Concerns About Reliability in the Trial to Assess Chelation Therapy (TACT)-JAMA CV Medicine at the Cleveland Clinic Published-JAMA in same issue as TACT Main criticism is that >60% of study sites run by integrative practitioners High dropout rate in placebo group Suggests unblinding took place Suggests ignore the study Conflicts of Interests: Dr Nissen reports grants/grants pending from Lilly, the Medicines Company, Amgen, Takeda, Novo Nordisk, Vivus, Orexigen, Novartis, Pfizer,
and Resverlogix; May be next head of the FDA MBS-ACAM Chelation Workshops 9-20-13 47 Current Lead Quackbuster: David H Gorsky MD, PhD-Surgical Oncologist Criticizing the Trial to Assess Chelation Therapy (TACT) is defending sciencebased medicine (Orac) Shame on JAMA! Shame on NCCAM and the NHBLI for funding this nonsense! And, yes, shame on all the shruggie cardiologists who are apparently unwilling or unable to look David H Gorsky MD beyond the hype. (http://scienceblogs.com/insolence/2013/03/28/criticizing-thetrial-to-asess-chelation-therapy-tact-is-defending-science-basedmedicine ) MBS-ACAM Chelation Workshops 9-20-13 48
Possible Influence of Pharma on David Gorski MD David Gorskis possible influence by the pharmaceutical company Sanofi-Aventis, which issues grants to Dr. Gorskis department at Wayne State University For a series of E-mails related to this issue as it relates to Gorskis attack on anyone who questions vaccines, see Jake Crosbys article with Dr. Gorskis responses at: http://www.ageofautism.com/2010/06/david-gorskis-financial-pharmaties-what-he-didnt-tell-you.html MBS-ACAM Chelation Workshops 9-20-13 49 Retrospective Analysis of Events Related to EDTA Chelation-Terry Chappell MD 2005: Chappell and seven colleagues published a
retrospective study showing patients with known CV disease treated with EDTA had a much lower incidence of cardiac events (MI, need for surgery, etc) than a comparable group treated with conventional cardiac care Conventional care included: Angioplasties, coronary artery bypass surgery and medical management MBS-ACAM Chelation Workshops 9-20-13 50 Dr. Chappells Study (continued)
Same endpoints as TACT trial, but much smaller study and not prospective, randomized or doubleblind with placebo Mirrored the results of TACT showing that EDTA chelation therapy appeared to prevent future cardiac events; Study published 7 years before presentation of TACT results Both studies showed that the main event that occurred was an invasive procedure (angioplasties, stents, CABG) MBS-ACAM Chelation Workshops 9-20-13 L. Terry Chappell MD 51 Comparison of Dr. Chappells
Retrospective Cardiac Events Study with TACT Retrospective TACT Patients Treated 220 854 Sites 8 134
Age 64 65 Previous Cardiac Surgery 71 683 Number of Treatments 58 32 Years of follow-up
8 (47) 130 (157) MBS-ACAM Chelation Workshops 9-20-13 52 Possible Reasons for Retrospective Results Being Better than TACT (1) TACT group patients at more severe risk as evidenced by them having more vascular surgery prior to the treatment; (2) Retrospective group received on the average a almost twice the number of EDTA infusions; (3) Retrospective group had more maintenance treatments (4) Probably much more emphasis on nutrition and lifestyle changes in the retrospective group (5) Retrospective group probably received much more
elaborate supplement program than the TACT group. MBS-ACAM Chelation Workshops 9-20-13 53 More Information about Disodium EDTA Chelation Therapy http://drcranton.com/chelation.htm Slide presentations Specific papers Patient testimonials Videos Lectures Book: A Textbook of EDTA Chelation Therapy: Edited by Cranton; Available from Amazon MBS-ACAM Chelation Workshops 9-20-13
54 Presidents of ACAM ACAM Presidents 1. Harold Harper MD (D) 8. Richard Casdorph MD 15. Allan Magaziner DO 2. Garry Gordon MD, DO 9. Michael Schachter MD 16. Kenneth Bock MD 3. Bruce Halstead MD (D) 10. L. Terry Chappell MD
17. Jeanne Drisko MD 4. Murray Susser MD 11. Ralph Miranda MD 18. Eleanor Hynote MD 5. Ross Gordon MD (D) 12. Michael Janson MD 19. Neil Speight MD 6. Elmer Cranton MD 13. Ted Rozema MD
20. Allen Green MD 7. James Frackelton 14. Ronald Hoffman MD MBS-ACAM Chelation Workshops 9-20-13 55 Where Do We Go From Here? Controversy will continue with strong attacks against EDTA chelation therapy for CV disease and pressure not to do any more studies Medical system is failing both clinically and financially largely because of the complicated relationships among corporations, governmental agencies, organized medicine and the media How can all of this be reversed and the health
system be improved? (It wont be easy!!!) MBS-ACAM Chelation Workshops 9-20-13 56
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