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COMPASS Pathways News | December 2018 Issue

As 2018 draws to a close, we reflect on another busy year and share our highlights of the last few months with you.

We have continued to make good progress since our last update: beginning patient recruitment in five of our treatment-resistant depression trial sites; gaining approval and Breakthrough Therapy designation for our trial from the US Food and Drugs Administration (FDA); reaching the halfway point in our healthy volunteers study; securing £25m in funding; and convening the first meeting of our Scientific Advisory Board.

We receive emails from so many people who are suffering, or are close to someone who is suffering, with treatment-resistant depression. These stories motivate us all every day at COMPASS. Our mission – accelerating patient access to evidence-based innovation in mental health – remains critical while the incidence of depression and other mental health challenges continues to rise. More than 100 million people have treatment-resistant depression (TRD) and depression remains the leading cause of disability worldwide. We simply cannot ignore this and are determined to do our part in alleviating it. We remain focused on developing psilocybin therapy for the safe and effective treatment of patients with depression, for whom existing treatments do not work.

Treatment-resistant depression (TRD) trial

Our phase IIb clinical trial for psilocybin therapy for treatment-resistant depression has now been fully approved in the UK, the Netherlands, Canada, the US, and Ireland. Further approvals are expected in additional European countries over the next few months. Patient recruitment has begun in trial sites in the UK, the Netherlands, and Ireland.

Treatment room in TRD trial

In October, we held an Investigator Meeting and therapist training for our North American sites. These sites, across the US and Canada, will begin patient recruitment in the first quarter of 2019.

Breakthrough Therapy designation

In October, the FDA awarded Breakthrough Therapy designation to psilocybin therapy as a potential treatment for treatment-resistant depression. Breakthrough Therapy designation is given to therapies for which preliminary clinical evidence shows a potential substantial improvement over available treatments. This is a strong endorsement for the potential of psilocybin therapy and one that will increase the chances of getting this treatment to the many people suffering with treatment-resistant depression. The designation means the FDA will be committed to supporting our clinical development programme and will work closely with us to ensure the process is as efficient as possible.

Breakthrough Therapy designation is also a mark of recognition for the vision and extraordinary work of generations of psychedelic researchers and therapists before us.

Healthy volunteers study

Our healthy volunteers study is halfway through. The study is taking place at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at King’s College London, and explores the short and long term effects of medium and high dose psilocybin on social, emotional and cognitive functioning, as compared to placebo. The study also provides a platform for therapists in our TRD trial to support volunteers under the guidance of our expert therapists, as part of their professional training.

We expect to complete the healthy volunteers study in the first half of next year and to report findings in the second half.

Fundraising

We have completed our Series A financing round, raising £25m from a group of investors who share our commitment to bringing psilocybin therapy to as many patients as possible. The funds will enable us to complete our healthy volunteers study and phase IIb trial.

Scientific advisory board

In November, we held the inaugural meeting of our scientific advisory board (SAB), a group comprising experts in neuroscience, psychiatry, neuropsychopharmacology, and regulatory science. With our SAB, we have begun to refine our clinical development plans and to explore ideas for additional studies in the future, to complement our work on treatment-resistant depression.

Looking ahead to 2019

Our progress and our achievements have been made possible by the dedication of our strong in-house team.

Our team continues to grow, and we are delighted that Hans Eriksson will be joining COMPASS in January as our new Chief Medical Officer. Hans was most recently Senior Director, Clinical Research for Depression and Pediatrics at H Lundbeck. He brings a wealth of experience in taking medicinal products to patients and we look forward to working with him as our clinical development programme continues. Ekaterina Malievskaia, COMPASS co-founder and current Chief Medical Officer, will take a more strategic role from 2019, overseeing R&D and our therapist training programme.

We enjoy a vibrant internship programme at COMPASS. This year we had 11 interns from leading European and US academic institutions, spending on average three months at COMPASS, and learning and contributing to different teams - from clinical trial management and operations, to market access, business development and fundraising. We will continue this programme in 2019.

In addition to our talented colleagues and enthusiastic interns, we are fortunate to work with an exceptionally skilled and dedicated group of advisors and partners. We are all excited about the next few months and each step that takes us closer to our goal of accelerating access to help patients.

In 2019, we will complete and report out on our healthy volunteers study. We also aim to complete recruitment for our treatment-resistant depression trial. While we are not pre-empting what the science will tell us or what the results of the trial will be, we have started the critical and complex work on market access strategy, so that we can be ready to bring psilocybin therapy to patients without delay and in a way that makes it accessible and affordable to as many people as possible.

In the spirit of the holiday season and on behalf of our board members, scientific advisors, investors and supporters, COMPASS has made a donation to One Mind, a US-based non-profit organisation dedicated to accelerating research in mental health though the principles of large-scale open science. We support and share their goals which are very much aligned to the work we are doing at COMPASS.

With only a few days left in 2018, we wish everyone a very happy holiday season, and all the best for the New Year. 

Your feedback

If you’d like to know more about what we are doing or have comments about COMPASS Pathways News, please get in touch with us at info@compasspathways.com.

Welcome to Fall Interns

Fall is here and COMPASS Pathways is thrilled to welcome new interns to the team!  We were impressed with the experience and skills of our fall applicants. After multiple rounds of interviews, five additions were made to our team. They have come from multiple universities and corners of the world, and we are excited to work with each of them! They are contributing to our activities in various functions including in marketing, research, and clinical trials operations.

Each brings their own unique skill set, and we can’t wait for them to add to our company’s success! Learn a little more about our interns below:

 

              Ali Mahomed

 

Hometown: Kingston upon Thames, UK
Favourite Food: Sashimi
BSc Statistics: London School of Economics and Political Science

 

 

 

 

 

              Candice Li 

Hometown: Changchun, China
Favourite Food: Matcha & Black Sesame Ice Cream
MSc Management: London School of Economics and Political Science
BA Business Economics: University of California, Los Angeles

 

 

 

 

              Nisha Thiara

 

Hometown: Leeds, UK
Favourite Food: Miso Pork Ramen
MSc Early Intervention in Psychosis: King's College London
BSc Psychology: University of Leeds

 

 

 

 

              Jade Raffle

 

Hometown: Suffolk, UK
Favourite Food: Sushi
PhD Cardiology and Genomics: Royal Veterinary College, U. of London
MSc Human Evolution and Behaviour: University College London
BSc Zoology: Queen Mary, U. of London

 

 

 

              Jake Jin-An

 

Hometown: Singapore, Singapore
Favourite Food: Fishball Noodles
BSc Actuarial Science: London School of Economics and Political Science

 

 

 

 

 

              Chloe Tan

 

Hometown: Kuala Lumpur, Malaysia
Favourite Food: Rice Krispies
LLB Law: London School of Economics and Political Science

 

 

 

 

 

 

Navigating Mental Health: COMPASS Pathways’ Psilocybin Research Program

Article written for the MAPS Bulletin Winter 2018

By Ekaterina Malievskaia, MD, MSc
Chief Medical Officer and Co-Founder

 

I first came to psychedelic research from a very personal experience with the limitations of psychiatry. I am a physician. George Goldsmith, my partner in life and business, has worked on complex regulatory and ethical issues of public-private collaboration. But despite our backgrounds, nothing prepared us for the devastation caused by the failure of the mental health care system when my son became ill. Even when the best doctors in the best institutions gave up on us, I kept looking for solutions. As we shared our story with friends and strangers, we realized that all of us are affected by the mental health crisis. And in the depth of our despair, we were still aware of how fortunate we were: we had resources and connections, and we could understand and assess the risks and benefits of emergent evidence for novel approaches. We resolved to make a difference for families who are in dire need of better treatments.

The early days

George and I were impressed by the vision and scientific rigor of the researchers at the Multidisciplinary Association for Psychedelic Studies (MAPS) and the Heffter Research Institute. Immediately after our first Heffter Board meeting in 2014, we offered not only financial support to the field, but help with regulatory strategy so that patients could benefit sooner. Despite significant challenges, we remain true to these commitments four years later.

In 2015, we created a US/UK non-profit, COMPASS, to support a pragmatic research project into psilocybin for psychological distress in hospice on the Isle of Man. Margaret Simpson, the visionary CEO of the hospice center, secured the support of the government, and together we received permission to train the first group of psychedelic therapists with psilocybin. There was only one obstacle: the psilocybin was not yet available from the Usona Institute or from the University of Wisconsin, both of which were also doing psilocybin research. Rather than wait, some of COMPASS’ Board of Trustees members recommended that we manufacture psilocybin ourselves. Given our mission, and uncertainty about the availability of psilocybin made under current Good Manufacturing Practices (cGMP), we followed their recommendation.

From its establishment in 2015 through its dissolution in 2017 (more on this later), COMPASS was 100% funded by George and me. No other donor funding was ever raised. We anticipated that if we followed the published process of synthesis, the cost of manufacturing would be in the range of £350,000 to £750,000 ($460,000 to nearly $1 million). We set out to create our supply for research in Europe. However, while we shifted our focus to the manufacturing of GMP psilocybin, the hospice CEO retired, the political leadership of the Isle of Man changed, and the opportunity passed.

The process of synthesis and formulation turned out to be much more complex and expensive than anticipated. We funded this work out of our personal funds, and the ever-rising cost was simply outside of our reach. That led George and me to seek legal advice to establish a drug manufacturing company eligible for tax credits under a UK government program that helps underwrite the cost of medicine research and development. That option, as well as other government incentives, is not available for non-profits. We formed that company, COMPASS Pathways Technologies Ltd, in June 2016.

In August 2016, Heffter researchers asked us to write a regulatory commentary on the upcoming publication of two landmark studies of psilocybin for cancer-related distress. Our advisor, the former head of the UK regulator, the Medicines and Healthcare products Regulatory Agency, Professor Sir Alasdair Breckenridge, agreed to do this. Heffter researchers also agreed for us to share the studies with the European Medicine Agency’s Scientific Advice Working Party in October 2016, a few weeks prior to the studies’ publication. The meeting with the EMA team was pragmatic, collaborative, and sobering. The regulators acknowledged the early evidence of efficacy, but encouraged us to focus on the indication of major depression instead. We shared the details of these discussions with both Heffter and Usona to help inform their regulatory strategy and further study designs.  

We took a sabbatical to consider our options. It was clear there were no political barriers to developing psilocybin as a medicine should the science meet regulatory standards. If we wanted to explore the therapeutic potential of psilocybin for depression, we were expected to take the traditional clinical development path, just like any other Investigational Medicinal Product (IMP). This meant we needed to go back to basics, starting with preclinical and simple dose-finding studies. It also meant the overall cost of development of psilocybin for the indication of depression would be over £100 million ($130 million).

We knew we would not be able to raise the necessary funds through donations since the clinical research was still in an early stage, and the indication of depression is among the most challenging ones. If we were to spend over £100 million on drug development, we wanted the solutions to be affordable, scalable and sustainable. In February 2017, we made the decision to establish a for-profit life sciences company. We renamed the for-profit drug development company to COMPASS Pathways. We started the process to wind-down the non-profit shortly thereafter. The only asset that we developed that had value following the EMA advice to focus on the indication of treatment resistant depression was the name and the branding work we commissioned. While this was of no value to anyone else, we purchased this asset for the same amount it cost to develop. This was independently reviewed and approved by the non-profit board of trustees.The non-profit was only funded by us personally and had no outstanding obligations to others, so the transition to for-profit was legally and logistically straightforward.

Manufacturing and patenting

While psilocybin is a naturally occurring molecule, psilocybin as an Investigational Medicinal Product or IMP is a regulatory entity that includes a detailed description of a GMP-compliant, scalable and reproducible manufacturing process; associated preclinical data; and ongoing safety data collected in clinical trials. The IMP can be thought of as a product’s fingerprint, so that regulators can recognize the safety and efficacy evidence gathered in the clinical trials as it relates to this unique product. The creation of an IMP is an extremely complex and expensive process that requires sustainable funding and a serious multi-disciplinary team effort. Based on our experience and the regulatory input from EMA, we now estimate that the development process will continue through marketing authorization and cost over £3 million (nearly $4 million).

In the process of synthesis, formulation and creation of preclinical data, we reached out to the researchers at Heffter and Usona with offers to share experience and ever rising cost, the last conversation being at PS17 in Oakland. Shortly after, the initial phases of the synthesis and formulation were completed, and psilocybin became the Investigational Medicinal Product.  From that point on, for the reasons of data consistency, there was no regulatory acceptable mechanism of “sharing” it other than through standard licensing agreements for the use of IMP. This is the way clinical research regulation works around the world.

As the previously published synthesis processes did not scale to meet regulatory standards, we had to invent our own process. As he would have done for anyone who would have asked for his help, David Nichols advised our manufacturing team. With his support our team has solved over 60 distinct technical problems in the synthesis and formulation process. Some of these inventions became the basis for our manufacturing patents. In general, patents provide an opportunity for an organization willing not only to take a significant financial risk to recoup the expenses, but more importantly, to ensure integrity of the data collected before and after the approval.

Our patents do not preclude others from creating a range of different solutions for the synthesis and formulation of psilocybin; nor do they preclude the use of naturally occurring mushrooms, extracts, or any other products created by alternative synthesis and formulation routes. Equally, our patents do not prevent other clinicians from using our product or any psilocybin-containing products in conjunction with the types of therapy or psychological support they judge to be helpful, as long as it does not jeopardize patient safety. Lastly, neither our patents, regulatory strategy, nor pricing strategy have an impact on the practices of the underground community of practitioners in nonclinical settings.

Our exclusive contract with the drug manufacturer does not prevent others from choosing among many different competing manufacturers through the standard Request for Proposal (RFP) process. The advances of science may now offer new creative solutions for the synthesis and formulation of psilocybin with new partners for those who are willing and able to spend the time, effort, and funds to create an alternative psilocybin-based IMP.  

While we have created the supply of psilocybin for our own research, we have made the unusual decision to share it with qualified independent researchers free of charge in exchange for being able to use their safety data. This is not a commercial decision, but yet another way to accelerate the generation of clinically relevant evidence that may ultimately improve patient outcomes.  

This process has proven to be challenging at times. As we have learned, university legal departments and technology transfer offices are vigilant about the potential Intellectual Property (IP) that might be created in the process of investigator-initiated studies. This IP, despite the best intentions of the researchers, does not belong to the scientists, who have limited say in how it is used by their institutions. In the event of IP creation, Technology Transfer Offices have a legal obligation to license it out to the ‘highest bidder’ with the most aggressive and scalable business model that will generate the most return for the academic institution. Even though such IP would be created by independent researchers with our IMP, in order to use the invention, we still have to compete with other commercial entities who might have different ethics or commercial goals.

This is an important consideration for the signatories of the Statement on Open Science and Open Praxis who work for academic institutions, as they need to align with their institutions on terms of IP licensing. The core principle of the statement is that knowledge created by signatories is open to all - that is, the knowledge is to be given away unconditionally by relinquishing researchers’ rights to protect it and to control who gets to use it after it becomes public.

We believe our patent strategy offers some protection against uses that may not be fully aligned with our mission to create access to innovative treatments for as many people as possible at an affordable cost to patients and healthcare systems.

Our focus: improving outcomes for the maximum number of people

Many people have asked us about our business model. Given that we are in the early stages of the development, the model is still evolving and will largely depend on the conditions of the regulatory approvals. In general, US law focuses on private companies maximizing value for shareholders only. UK corporate law is different: it requires us to create value for both shareholders and stakeholders. As a UK-based company, every COMPASS Pathways Board meeting starts with a reminder of this commitment.

Businesses might have different strategies to create value for shareholders. Charging high prices and stifling competition is one of them, but it is not the approach we plan to take. Instead, our goal is to provide broad access to all in need regardless of their ability to pay, creating greater value for health systems and translating to lower health insurance premiums and decreased healthcare cost. This is the approach our shareholders invested in and continue to support.

The high cost of clinical trials and drug development aside, the cost of manufacturing GMP psilocybin itself post-regulatory approval is likely to be relatively low. The future cost of psilocybin therapy will be determined at the point of care delivery by the treatment models, the services provided by the treatment centers, but mainly by the fees of individual providers.  The creation of reimbursable models of care then becomes essential if we are to ensure that everyone who would benefit from psilocybin therapy can access it regardless of their ability to pay. It might be that “a thousand flowers will bloom” – and eventually the best models will prevail simply through quality and price competition, or that treatments will be rolled out in a more regulated way. This will require constant feedback and frequent course correction, as we continue to learn from our collective experience.

One way to decrease this uncertainty and ensure the accessibility of the treatment is by engaging in frequent in-depth conversations with the regulators and payers early in the process, just as we suggested after our first Heffter Board meeting in 2014. This remains our main strategy today.

To date, we have had conversations with regulators in many different countries in Europe and North America. We have assembled hundreds of pages of detailed feedback on the clinical development of psilocybin for depression and other indications, and on regulators’ general views of the challenges and opportunities for the clinical development of psilocybin. We share these insights regularly with MAPS. We also offered to share our plans and experience with Usona and Heffter. However, we understand that the psychedelic community is facing many challenges as it grows and some might not consider these perspectives a priority at this time.

We realize now that we could have taken more time to communicate with researchers who supported us during our early non-profit stage. At that time, we simply assumed that we were all motivated by the urgent need to create safe, effective, and sustainable options for patients. In our drive to get things done, we may have unintentionally hurt some people by not communicating clearly enough about our intentions and decision process that led us to move from non-profit to profit and from a focus on existential distress in cancer patients to treatment-resistant depression. We sincerely regret this and intend to do a better job in the future. Today, many researchers have continued working with us, while others have chosen not to, citing their discomfort with a for-profit approach. We respect their choice.

We also appreciate that not everyone agrees with our model. We believe different models of care and organizational structure can co-exist, and we embrace healthy competition through creating alternative solutions. We also understand that in the diverse psychedelic community, there is a range of views on how to move forward. We appreciate the dedication, skills, and achievements of those who have chosen to work on legalization efforts, and we do not think our models are contradictory. In fact, arguments for decriminalization can be enhanced by the evidence generated in large-scale clinical trials conducted according to the highest regulatory standards. Regardless of the results of the trials, the individual patient experiences and extensive safety data collected and published in the process can be of significant value in helping change public and legislative opinions.  

The “elders” of psychedelic research have triumphed at what they set out to do. The world is paying attention, patients and clinicians are hopeful, leading research institutions are hosting conferences and developing research ideas, and institutional and private funders are willing and able to support further development. Scientists and clinicians now have a real chance to offer hope and help for millions of people suffering from psychological distress, regardless of their spiritual practices or ideological convictions.

The field of psychedelic research is entering a new chapter. This is both exciting and highly uncertain, as this work has never been done at scale and in full public view. Working in this historically sensitized and highly regulated space takes a wide range of skills, experience, sustainable funding, teamwork and collaborations across disciplines. With care and respect for differences of opinions, we know it is possible to have a constructive and thoughtful dialogue, and to collaborate in the interests of patients in need. We at COMPASS Pathways are committed to doing our part. We look forward to sharing lessons of successes and challenges with many of you in the future.

In the meantime, my son has recovered and now lives a happy and productive life. This was inconceivable just three years ago. Our story is not simply the story of a miracle cure, but the story of access to innovation, particularly for those who cannot afford it. We will have walked this challenging path so other families do not have to do so.

COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression

For online press release, see: https://www.prnewswire.com/news-releases/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression-834088100.html

COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its psilocybin therapy for treatment-resistant depression.

The FDA designates a drug as a Breakthrough Therapy if preliminary clinical evidence shows that it may demonstrate substantial improvement over available therapy. Breakthrough Therapies are supported by the FDA throughout the clinical development programme to ensure as efficient a process as possible.

Breakthrough Therapy designation is a significant milestone for psilocybin therapy and psilocybin research, and a testament to the work done over many years by research teams in the US, the UK and Switzerland. The Heffter Research Institute was the first to fund research in this field, and supported early studies at Johns Hopkins UniversityNew York University, and Harbor-UCLA. In the UK, the Medical Research Council backed the proof-of-concept study of psilocybin for treatment-resistant depression at Imperial College London in 2015. COMPASS Pathways is now running the first large-scale psilocybin therapy clinical trial for treatment-resistant depression, which will take place in Europe and North America over the next year or so.

George Goldsmith, Executive Chairman, COMPASS Pathways, said, "This is great news for patients. We are excited to be taking this work forward with our clinical trial on psilocybin therapy for treatment-resistant depression. The FDA will be working closely with us to expedite the development process and increase the chances of getting this treatment to people suffering with depression as quickly as possible."

Treatment-resistant depression is a huge unmet need, affecting 100 million people around the world who do not respond to existing treatments. Depression is one of the fastest growing health problems we face today, and the leading cause of ill-health and disability worldwide. The Breakthrough Therapy designation for psilocybin therapy highlights the importance of supporting early research that can be translated to clinically meaningful outcomes.

Dr Robin Carhart-Harris, Head of the Psychedelic Research Group, Imperial College London, said, "In our 2015 study, we provided psilocybin to 19 patients in a clinical setting, coupled with psychological support, and found promising signals of efficacy and safety as treatment for treatment-resistant depression. The Breakthrough Therapy designation is a strong endorsement for the potential of psilocybin therapy. We look forward to learning more as further clinical studies are carried out, by our team at Imperial College as well as in COMPASS's multi-centre trial."

Dr David Nichols, Chairman of the Board, Heffter Research Institute, said, "Since its inception in 1993, Heffter has been helping to design, review, and fund the early phase clinical studies on psilocybin at research institutions in the US and Europe. We are delighted that psilocybin is being recognised as a Breakthrough Therapy and look forward to continuing our work with researchers and partners around the world so that we can alleviate the suffering caused by mental illness."

About COMPASS Pathways

COMPASS Pathways is a life sciences company, founded in 2016 to accelerate patient access to evidence-based innovation in mental health. We are developing psilocybin therapy through a late-stage clinical trial in Europe and North America for patients with treatment-resistant depression. We will improve mental health through the development of new patient care pathways, based on advances in neuroscience, psychotherapy, psychopharmacology, and technology. www.compasspathways.com

Enquiries:

Tracy Cheungtracy@compasspathways.com , +44-7966-309-024
Chris Struttchris@compasspathways.com , +44-7850-546-135

Navigating Mental Health: COMPASS Pathways’ Psilocybin Research Program

Article written for the MAPS Bulletin Winter 2018, by Ekaterina Malievskaia, MD, MSc, Chief Medical Officer and Co-Founder of COMPASS Pathways

COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression

“This is great news for patients. The FDA will be working closely with us to expedite the development process.” George Goldsmith

In the news

CBC Radio: Psychedelic drugs and the future of psychiatry

Canadian Broadcasting Corporation programme about psychedelics and mental health, featuring George Goldsmith.

Building a Psychedelic Enterprise

Video of an event hosted by UCL Society for the Application of Psychedelics and LSESU Neuroscience Society. COMPASS founders talk about patients, profits, patents and psychedelics

Psychedelic Times: Interview with Rick Doblin, founder and executive director, MAPS

Psychedelic Times interviews Rick Doblin, founder and executive director of the Multidisciplinary Association for Psychedelic Studies (MAPS), about psychedelics and capitalism.

Press releases

Science & technology

The renaissance of psilocybin as a viable treatment option

Article from pharmaceutical-technology.com listing current clinical trials involving psilocybin.

Patient experience

Psychedelic Healing

Could magic mushrooms help reboot the brain? Article from BBC Focus Magazine focusing on the experience of Kirk Rutter, a participant in the Imperial College psilocybin therapy study

Can Magic Mushrooms Provide Lasting Peace?

Psilocybin has been illegal in the United States for more than 40 years. But Mr. Mihai, who had just finished treatment for Stage 3 Hodgkin’s lymphoma, was participating in a study looking at whether the drug can reduce anxiety and depression in cancer patients.

Just One Dose of This Psychedelic Drug Can Ease Anxiety

In two new studies released simultaneously by researchers at New York University and Johns Hopkins, doctors reveal that a single dose of psilocybin—a compound from magic mushrooms—can ease anxiety and depression for up to six months.

Roland Griffiths Talks About Psilocybin Research

Insights from Professor Roland Griffiths into the psilocybin research carried out at Johns Hopkins University looking at anxiety, depression and psychological distress in cancer patients.

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