This is an opinion piece by Jenna Celmer, Stakeholder Engagement Manager for the PCC.
Why is the Partnership for Clean Competition a global leader in anti-doping research? I could go on for days, but one of the biggest reasons is we have amassed the best experts in the field to oversee, vet, and direct the anti-doping projects we fund.
The PCC's Scientific Advisory Board (SAB) meets three times annually to discuss the funding applications obtained through our formal grant cycles. The most recent meeting was held May 23rd and 24th in Chicago, and as the PCC's newest employee it was my first opportunity to see our board in action.
I was impressed.
Three aspects made the meeting, as well as the scientific operation of the PCC, successful: passion, diversity, and expertise.
Buy in from your stakeholders is important. Buy in from your board members is paramount. I have been involved with many boards wherein the impetus for membership is prestige, career advancement, or worst of all – obligation. The PCC, however, is quite fortunate to retain board members motivated by a passion for facilitating clean sport and protecting clean athletes through science.
In this case, passion translates to engagement – engagement with emerging PCC strategy, new anti-doping talent, and the scientific field. When challenges in the field were discussed – for example, recruiting and retaining young talent within the anti-doping research sphere – board members were quick to not only suggest methods for improving and supplementing our current Fellowship Program, but also volunteered to take on roles outside of the meeting which brought us closer to meeting strategic goals in this arena.
Our board members also act as the ambassadors to our organization, circulating information regarding our grants and events to their own circles and generating interest as only experts and influencers can.
Despite exceptionally busy schedules, this commitment to the PCC's interests is a tremendous advantage.
While a deep responsibility to the scientific pursuit of clean sport drives our SAB, it is a variable collection of applicable skills that truly engenders effectiveness.
Diversity within PCC research is exceptionally important. We encourage collaborative team science through our working group program in part to ensure representation from myriad scientific disciplines, global regions, and backgrounds. Luckily, similarly diverse representation can be seen on our advisory board.
The SAB is made up of advisors with both MD's and PhD's, hailing from a number of different scientific specialties (ranging from hematology to endocrinology to the study of androgens) at differing stages of career. We are fortunate to receive input from members working directly with sporting leagues, experts on lab practices and studies, former athletes, and practicing medical practitioners.
The result of such a motley crew is a dynamic and holistic look at the grant projects and industry challenges which face the SAB. Questions generated from lab directors differ from those asked by biochemists or athletes – and more diversity of every kind means more (and better) answers.
The SAB is a well-rounded yet cooperative team. And much of their value lies precisely in that fact.
While a diverse and passionate board are integral pieces to the PCC's success, they are nothing without the necessary scientific knowledge to guide our research priorities and funding strategy. An ability to identify and channel focus to the critical issues facing anti-doping is vital to good governance, and a main factor in meeting the PCC's mission. One needs only to visit our leadership page bios (visit now!) to understand the achievements, skill and profound knowledge base of the SAB – and those are just a sampling.
Our Scientific Advisory Board has earned their significant know-how over years of working within the anti-doping and related fields and their mastery shows. You will not find a more credible team within the scientific sphere of anti-doping research.
To be fair…
Behind the scenes, there are many other reasons the PCC's Scientific Advisory Board is able to contribute meaningfully to our mission, including maintaining contact (and interest!) between meetings (both with staff and each other), not being afraid to ask tough questions or challenge the status quo during meetings, and maintaining a sense of humor and camaraderie during breaks and social times that bonds the group. However, the trifecta that is enthusiasm, heterogeneity, and genius truly drives the success of the PCC.
And I'm thrilled to have the opportunity to learn from them.
Dr. Thevis, (PhD, GTFCh), the anti-doping scientist and professor from Germany, speaks with the PCC about his Mildronate study, choosing the anti-doping discipline, and what's next on his radar.
What got you started in anti-doping research? I was a third year chemistry student at the University of Aachen when I started a student job in pesticide residue analysis, which triggered my interest in analytical chemistry. As I was also a sports science student at the time, I took advantage of an opportunity to combine my interest in both sport and chemistry through pursuing a PhD in anti-doping research under the supervision of Professor Schänzer.
How did you first engage with the PCC? When the PCC initiative was started in 2008, it was greatly appreciated among anti-doping scientists. Historically, funding opportunities have been limited for this specialized field of research. My team and I had been actively looking for organizations such as the PCC that could be partners and sponsors of our anti-doping efforts. We're happy to report several successful applications thus far. What intrigued you about Mildronate? What prompted research into the substance? Mildronate (or Meldonium) was found in the possession of athletes about 10 years ago. Since then, the substance's relevance to doping controls was questioned sporadically, but information remained scarce. In 2013/2014, testing procedures applied to routine doping control samples indicated the presence of a compound in substantial abundance in a series of urine specimens. As the compound could interfere with the measurement of other known analytes, my team investigated further. The compound turned out to be Meldonium, and with the use of improved instrumental testing options, monitoring was facilitated, followed by explicit testing. Can you tell us a bit about the scientific process of your research? Mildronate is of low molecular mass and due to its composition and structure, a rather polar analyte. These properties are not ideal when using common testing methods, which rely heavily upon chromatographic-mass spectrometric approaches. However, my team was able to modify a routine test method and establish a dedicated confirmatory assay by using an in-house synthesized stable isotope-labeled internal standard hydrophilic interaction liquid chromatography (HILIC) coupled with high resolution/high accuracy tandem mass spectrometry. This combination was important as the internal standard compensated for a number of potential issues arising from the peculiar analytical properties of Meldonium, while HILIC enabled the required chromatographic separation required to accurately determine the compound's molecular mass and that of its diagnostic product ions. Overall, an unequivocal identification of Meldonium was achieved. You found Mildronate positives in 2.2% of samples studied. Were the results what you expected to find? I was surprised to see this prevalence. It was considerably higher than I expected.
What are your thoughts on the PCC Micro-Grant program that was used to fund the Mildronate study? In my opinion, the PCC Micro-Grant program is extremely valuable. To render doping controls effectively and timely, anti-doping research requires not only conventional funding programs (which are undisputedly of great importance) but also a tool that allows reacting faster and enables the rapid production of information vital for handling imminent issues. Which anti-doping projects will you be pursuing next? Quite a few activities are planned, such as expanding doping control sampling options (e.g. by utilizing alternative matrices such as dried blood spots), and improving test methods to enhance the coverage of both established doping agents and emerging drugs. What would you consider your proudest scientific accomplishment? I would not have a definite answer to this question. There have been a few situations wherein we were told doping analysis related problems could not be solved using analytical chemistry. However, eventually we were able to prove quite the opposite. Why should a young scientist consider the field of anti-doping research? It is an enormously dynamic field of research. Many questions raised in this arena are related to other disciplines (e.g. toxicology, forensics, clinical chemistry, etc.), but necessitate a different angle and approach to provide the information relevant to sports drug testing. The enormous interdisciplinary aspect offers great opportunities for scientific exchange and cooperation; probably more pronounced than in most other fields of applied research.
Dr. Thevis is a Professor for Preventive Doping Research and Vice President of Research at the German Sport University Cologne's Institute of Biochemistry / Center for Preventive Doping Research. His research on Mildronate can be found at http://onlinelibrary.wiley.com/enhanced/doi/10.1002/dta.1788
A seminar at the University of Utah by Dr. Daniel Eichner, president of the Sports Medicine Research and Testing Laboratory (SMRTL) piqued Dr. Geoff Miller's interest back in 2014. Now, he's on track for a promising career in anti-doping research.
With a focus in Pharmaceutical Chemistry in graduate school, Dr. Miller had a big decision to make following graduation. On the table were job opportunities from pharmaceutical companies as well as a position within a children's research hospital in their cancer research program. However, after hearing Dr. Daniel Eichner speak about anti-doping science occurring in the SMRTL lab, his interest was piqued. Says Dr. Miller, "Many of these projects interested me, as well as the meshing between sports and science, so I chose [the anti-doping] route." Dr. Miller applied for a PCC Fellowship following graduation – and the PCC is glad he did.
Since being accepted into the program, Dr. Miller has been involved in myriad of activities, including the oversight of sample testing, assay validation, and certification for the handling of radioactive materials. Dr. Miller has also worked with Dr. Eichner to review biological passports for clients and will soon be training other analysts in safety and lab operations.
Importantly, Dr. Miller is also involved in a number of research projects, including determining markers for fluid balance, examining the administration and effect of 'Natesto', a new intranasal form of testosterone, aiding in the detection of autologous blood transfusions, and investigating plasma volume changes following an Ironman event. As impressive as that sounds, according to Dr. Miller, that's not all: "other projects are in the planning stage, but still require further design and approval from our institutional review board. As we seek approval for these projects, we are working on implementation of and efficiency in our hGH biomarker testing."
Of note, Dr. Miller has achieved one publication and two presentations as a result of his Fellowship work – so far.
For many young scientists, the opportunity to pursue research projects of interest, while learning the inner day to day workings of a lab sounds great – and Dr. Miller is no exception. In his own words, this combination "provides a great opportunity to see how the lab primarily operates and to understand many different aspects of sample analysis," key areas in any anti-doping career. In the future he hopes to spend time at additional laboratories 'to understand the differences between [laboratories] from both the sample operations and research standpoints."
Seeking institutional review board approval for projects was also a novel experience granted via the Fellowship Program and Dr. Miller ranks obtaining it for three separate projects as one of his proudest accomplishments, admitting "this was an aspect of scientific research that I never had to deal with in graduate school, so while I was aware of the concept, actually getting approval was something very new to me. It took quite a few weeks to understand the necessary steps required for approval application, but once the first project went through, the next couple fell in line nicely."
Outside of the lab, Dr. Miller showcases his love of sport – one of the reasons he entered anti-doping science originally: "Having played soccer in college, it has been difficult to let go so I continue to play in both indoor and outdoor amateur leagues in my free time. Additionally, I really enjoy the outdoors (especially in the warm weather seasons), and Utah is the perfect place for nearby hiking, camping, and biking."
When asked why other young professionals should consider a career in anti-doping, Dr. Miller provided sage advice: "I believe anti-doping science represents a relatively untapped market when it comes to research projects. There are so many questions still remaining to be answered in this field. Additionally, the field is always changing, which provides a level of excitement and requires a sense of urgency to solve some of the lingering issues." The PCC agrees wholeheartedly.
Dr. Miller exemplifies the tenets of curiosity, travail and a pursuit of real world impact which epitomize success in the field. The PCC is proud to say his career in anti-doping looks exceptionally promising, and our Scientific Advisory Board in particular is excited to support the future endeavors of Dr. Miller and the future young researchers who follow in his footsteps.
The PCC's unique Fellowship Program aims to attract and cultivate young anti-doping scientists in order to keep this innovative discipline manned by passionate and capable researchers.
To learn more or apply for the PCC's unique Fellowship Program, visit http://www.cleancompetition.org/Pages/programs-fellowship.aspx
To learn more about Dr. Miller's work in the SMRTL laboratory, visit http://www.smrtl.org/
We are excited to present to you our first newsletter: your opportunity
to explore a sampling of the achievements, perspectives and scientific projects
of our researchers, while keeping informed of funding deadlines and programs.
We hope you enjoy and encourage you to remain engaged with the PCC via our
newly launched social media channels.
In this quarter's
An interview with Dr. Mario Thevis regarding his Meldonium research, a look at
novel testing methodologies being explored by Dr. Jack Henion, and a sneak peek
at the date of our 2017 anti-doping conference held at MLB headquarters in New
PCC Newsletter Spring 2016.pdf
What a Drop Can Do:
Dried blood spot sampling (DBS) is a form of bio-sampling that has been used for decades to screen patients for diseases that can be identified via metabolic markers – such as congenital metabolic diseases in infants. More recently, the method has been tested in clinical pharmacokinetic studies, or the study of drug absorption, distribution, metabolism, and excretion. The technique involves collecting a drop of blood on a small piece of filter paper and allowing it to dry before being analyzed.
DBS has some clear advantages:
- Minimal volume requirements
- Easy sample attainment via finger stick
- Nominal training for sample attainment
- Ease of sample collection, transport, storage, and handling
- Highly stable samples – ranging from months to years once dried
A new weapon in the fight for clean sport?
For those working to enhance doping control programs across the athletic sphere, the above benefits make DBS an appealing proposition which offers both administrative and financial benefits. DBS methods replace the need for arduous shipping procedures involving dry ice with a simple envelope at room temperature, which may catalyze massive cost savings for testing agencies. As well, the small sample volumes mean the entire process is much less intrusive for athletes being tested – which may lead to more athletes embracing the process.
In fact, DBS's applicability to anti-doping initiatives has been of interest to the community for some time, especially to Dr. Jack Henion, who has been studying DBS for several years. Dr. Henion is Professor Emeritus of Toxicology at Cornell University in the Analytical Toxicology Section of the Diagnostic Laboratory within the College of Veterinary Medicine. He is also a co-founder, Chairman and CSO of Advion BioSciences (ABS), Inc., located in Ithaca, New York.
Dr. Henion is no stranger to bio-sampling. He has rigorous experience with method development and validation with Liquid Chromatorgraphy/Mass Spectrometry (LC/MS) analysis of real-world biological samples for numerous applications, and has received three Honorary Doctorate degrees in recognition of his international reputation in modern analytical techniques.
Renewing a Basic Approach:
The adoption of mass spectrometry as a tool for analysis enhanced the viability of DBS as a molecular assay tremendously due to the increased number of analytes able to be measured from just a dime-sized spot of blood – a simple finger prick, for most people. In fact, several studies using analytical methods such as LC/MS, sequencing and/or RT-PCR confirm DBS sampling works as well as tests performed with fresh blood samples across several classes of analytes – an encouraging truth for Dr. Henion and his team.
Currently, the team – located at Q Squared Solutions - is not only developing and validating methods for the bioanalysis of five classes of drugs using DBS (including opioids, THC, stimulants, beta blockers, and steroids – top candidates for use in doping), they are also developing a novel dried plasma spot (DPS) card which "can provide micro plasma samples from finger pick blood without the need for centrifugation or other laboratory techniques for producing plasma," according to Dr. Henion.
Both projects amount to easier sample collection in-competition and out, coupled with more cost effective transport to the laboratory for analysis.
Thanks to Dr. Henion and his team striving to develop innovative techniques for the analysis of biological samples, DBS and DPS could be the future of anti-doping collection and testing.
Learn more about the innovative development at Q2 Lab Solutions here.
The research we fund is driven by several factors, including a contemporary need for information on a substance or test, a need for new methodologies, or a researcher's passion on a given topic. In 2014/2015 many of the projects we funded focused on three major areas:
The goal of the PCC is to protect clean athletes through applied scientific research. Testing methods which are intrusive, inefficient, or costly are less likely to be performed with the regularity truly needed to deter athletes seeking an advantage. This is why it's so important for anti-doping researchers to consistently seek new technologies for detecting and measuring performance enhancing drugs and substances. While 2014 and 2015 focused on these three categories, 2016 has begun with a focus on two different alternate specimens: Dried Blood/Plasma Spots and Breath Analysis.
For example, the PCC has recently funded a Micro-Grant to investigate the capabilities of a novel breath test from Swedish company Sensabues to detect PEDs. The test has already been proven to detect illegal drugs such as amphetamines, cocaine, and heroin, but more information is needed to determine if the test could be useful in the athletic sphere. If so, athletes would need only submit to breathing into the device for 20 inhale/exhale cycles – an incredibly non-intrusive process that requires very little time or cost that is traditionally associated with drug testing. Athletes can quickly and easily return to their schedule and administrative costs decline dramatically, making the test much more likely to be used with great frequency.
Whether it be through breath analysis, dried blood and plasma spots, or most likely a combination of both, we at the PCC will be on the cutting edge of anti-doping research in order to protect the clean athlete.
As the world leader in anti-doping research funding, the PCC's mission is driven by a global movement of scientists pursuing a single, noble goal: providing scientific data to protect the integrity of sport. The research we fund is conducted by scientists from diverse nations and it impacts athletes around the world. The PCC believes that in the scientific community, diversity makes a difference because it ensures various viewpoints are taken into account.
PCC working groups, in particular, combine the talents of researchers from several nations. This combination of knowledge exemplifies how an emphasis on common goals and international scientific standards can bridge divides and produce solutions for large-scale scientific challenges.
The bi-annual PCC conference, held in New York City, is another platform that strengthens international scientific ties through dialogue. The conference brings together scientists from all over the world to teach each other, collaborate, and share their views on tackling anti-doping concerns which transcend individual countries or sport. The next PCC conference will be in April 2017.
While working groups and the conference are vital to the mission of the PCC, there is nothing more critical than the grants program. In 2014 and 2015, grant applications were received from 15 different countries spanning four continents, including Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, South Africa, Spain, Sweden, Switzerland, the United Kingdom, and the United States.
Nearly half of the projects funded by the PCC (44%) were conducted by researchers from outside of North America. Not including North America, multiple projects were funded in Australia (5), Belgium (3), Denmark (2), and Austria (2). In 2016, the PCC hopes to see applications from additional nations to further enhance the anti-doping thought leadership currently amassed in our network.
While the PCC's emphasis is on funding high quality scientific anti-doping research regardless of geographical point of origin, we encourage a global effort in the fight for clean sport. A consortium of scientists from varying backgrounds may investigate different questions, or approach similar challenges in different ways. Thus, a diverse scientific community is most likely to balance bias, while advancing the field of anti-doping research.
Efforts to penetrate the scientific landscapes of more European, Asian, South American, and African nations are currently underway and include social media outreach, a quarterly newsletter with current funding opportunities distributed to a 1,200 person, global distribution list, and direct outreach to top international research universities. However, the value of word of mouth cannot be underestimated, and efforts can be furthered tremendously by current stakeholders sharing their knowledge about our available funding programs.
The more applications the PCC receives, the more potential to enhance anti-doping knowledge and improve upon testing methods and detection windows. We urge scientists from around the world - concentrating in any discipline - to expand their scientific and geographical reach by submitting their anti-doping research project by July 1, 2016 for consideration during our next funding cycle.
The PCC catalyzes an impact on sport through our funding. The research we support is conducted by scientists of the highest caliber, on topics exclusive to improving anti-doping knowledge. Often, the research we fund represents unique pilot projects not being explored elsewhere in the world.
That being said, understanding our funding process and how funds are distributed is important. Beginning with this article, the PCC will be highlighting various aspects of our 2014 and 2015 funding to provide insight into the types of projects we support, including breakdown by region, cost, program, and affiliation.
Our initial foray into the PCC's funding process is a snapshot of our total accomplishments for the past two years (see below). The PCC is very proud to have funded over $6.5 million in quality scientific anti-doping research. Many of our studies have already spurred real-world changes in anti-doping testing or policy. For instance, the PCC funded a human growth hormone (HGH) biomarkers working group, which developed an impressive new method for detecting HGH to be instituted in WADA labs this year. The impact of several other studies will be announced in the coming months.
The PCC boasts an overall funding percentage of nearly 40% for 2014 and 2015, which is above our average funding percentage of 28%. Our research priorities (found here) guide our decision-making when it comes to funding scientists and projects. The PCC, through its Scientific Advisory Board, also provides technical assistance to applicants whenever possible. Often, when a study has scientific merit but requires some additional clarification, it is recommended for resubmission in our next cycle. Resubmissions made up 9% (3/34) of studies funded in 2014 and 2015.
Funding is also allocated across several different programs apart from our traditional grants, including our micro-grants program, working groups, and fellowships. The PCC hopes to increase funding to each of these programs in upcoming years.
In each of 2014 and 2015, the PCC funded a higher than average number of projects thanks to an increased number of quality applications from world anti-doping experts and applications from new scientists entering anti-doping for the first time. In 2016, the PCC hopes to build on this success through the support of innovative research and scientists, to include growing the field of talent through our fellowship program and facilitating collaborative efforts through our working groups.
While we are proud of our recent work, the PCC will remain steadfast in our commitment to innovation in 2016 and beyond.
The integrity of sport is worth protecting.
The science of anti-doping must be flexible enough to stay ahead of athletes and other support professionals who make the wrong choices when it comes to the use of performance-enhancing substances. Anti-doping science and research must work to protect clean athletes in a timely manner.
New substances and methods that athletes can use to seek competitive advantages are constantly emerging. Rapid responses to these threats to clean sport are essential. So too is staying ahead of the curve.
Anti-doping and other sport organizations seeking to protect clean athletes must be vigilant in unearthing and predicting agents of performance enhancement. From testing, to investigations, education, and results management, there is one common need to protect integrity of sport: that of quality scientific research.
This is why the PCC pioneered the micro-grant: funding with a quick turnaround for projects requiring less than $75,000 and fewer than six months to complete. When scientific information is needed by the anti-doping community to make policy decisions, develop tests, or produce reference materials, waiting for a formal grant cycle can be detrimental to clean sport.
PCC micro-grants can be funded in as little as one week to advance anti-doping science.
In one case, a project was funded within days to assess athlete usage of and develop a method for the detection of Mildronate. The results of the study were provided to the World Anti-doping Agency (WADA) within weeks of completion of the study, and the total project timeline was less than a year from submission of the application to publication in a peer-reviewed scientific journal
If you are a scientist with a project related to contemporary anti-doping research, submit a two page project overview, complete with scientific methodology and project budget for micro-grant consideration. Please e-mail Michael Pearlmutter at firstname.lastname@example.org with any inquiries.
Learn more about micro-grants here.
In the world of anti-doping, 2016 is a critical year. On January 1st of this year, the World Anti-Doping Agency (WADA) made several changes to its prohibited substance list. One of those was the addition of Mildronate (aka Meldonium) due to "evidence of its use by athletes with the intention of enhancing performance." (WADA Statement on Maria Sharapova case)
The evidence referenced is research funded by the PCC and conducted by Dr. Mario Thevis of Germany in early 2015.
Since January 1, over 110 samples have tested positive for Mildronate. While there are many unanswered questions surrounding the implications of the substance's usage, here's what PCC researchers have confirmed:
(For an in depth look into the PCC funded Mildronate research, visit: http://onlinelibrary.wiley.com/doi/10.1002/dta.1788/full)
The Mildronate case highlights the rapidly changing dynamic of the anti-doping sphere and the importance of an efficient and credible scientific response. Substances – whether newly created for doping or which exist already for medical purposes – are constantly being provided to athletes with an intent to gain an unfair advantage. Mildronate went from a virtually unknown substance in America to being present in 2.2% of samples studied in Cologne – a concerning metric in the anti-doping world. In this case, the speed and efficiency of the PCC process provided WADA decision makers the quality scientific research it needed to make an informed decision on Mildronate.
Mildronate is an excellent case study of the real world impact on policy and testing methodology the PCC makes.
And PCC funded research is just ramping up.
The addition of Mildronate to the Prohibited List is simply the forerunner of several policy updates and augmented testing methodologies that will be the direct result of research conducted by PCC experts.
In 2014 alone – the year the Mildronate research was carried out – more than $4.4 million was distributed to researchers. Despite its massive impact on contemporary athletics, the Mildronate study represented one of more than 20 projects in the 2014 year.
The PCC expects significant future impact from several other studies carried out in the same year and will continue to update stakeholders about developments resulting from our labs around the world. For now, we'll leave you with a partial list of projects funded in 2014. Which of these do you expect to make the biggest impression on athletic policy in the future?
Dr. David Chen at the University of British Columbia for his work entitled "Capillary Electrophoresis-Mass Spectrometry Glycoscreening for Detection of Doping."
Dr. Daniel Eichner at Sports Medicine Research & Testing Laboratory for his work entitled "Evaluating Hepcidin as a Biomarker of Blood Doping."
Dr. Daniel Eichner, Dr. John Higgins, and Dr. Jaime Watkins at Sports Medicine Research & Testing Laboratory and Massachusetts General Hospital for their work entitled "Detecting Autologous Transfusion by Measuring Alterations in the Dynamics of Red Blood Cell Maturation and Recycling."
Dr. Peter Van Eenoo at the Doping Control Laboratory at Ghent University for his work entitled "Detection of new Rev-erbα agonist as potential doping agents: SR9009 and SR9011.
Dr. Jack Henion at Quintiles for his work entitled "Screening for Drugs via LC/MS Analysis of Dried Blood Spots and Dried Plasma Spots."
Dr. Benjamin Levine at University of Texas Southwestern Medical Center for his work entitled "Safety, Efficacy, and Detection of Xenon Supplementation for Increased Red Cell Mass in Highly Trained Athletes."
Dr. Kara Lynch at the University of California, San Francisco for her work entitled "Optimization of High Resolution Mass Spectrometry for Identification of Novel Doping Agents and Metabolites."
Dr. Tony Butch at the UCLA Olympic Analytical Laboratory for a Center of Excellence grant.
Dr. Daniel Eichner at Sports Medicine Research & Testing Laboratory for a Center of Excellence grant.
We're excited to make more big announcements. Stay tuned.
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