This past December, the FDA issued a Complete Response Letter to drug manufacturer Sanofi in response to Sanofi's application seeking approval for Tolebrutinib, the first in a new category of investigational disease-modifying therapies to undergo FDA review. A Complete Response Letter is an official letter from the FDA to a drug manufacturer stating that the agency can't approve a new medicine in its current form. It's not an outright "no" that kills a project; it's more like a "not yet." However, this Complete Response Letter raised some issues which, at first glance, don't appear to be easily fixable.

Sanofi has pointed out that the issues raised in the Complete Response Letter were markedly different from the guidance they received from the FDA over the course of this approval process. Sanofi has also indicated that it would work with the FDA to find a path forward for Tolebrutinib.

Dr. William Conte, an MS Specialist and a principal investigator in the Phase 3 clinical trial for Tolebrutinib, has published an article responding to the FDA's Complete Response Letter. This week, Dr. Conte joins me to discuss the FDA's action and his response to that action.

We have a lot to talk about! Are you ready for RealTalk MS??!

This Week: We're at the 2026 ACTRIMS Forum :22

Check out the official ACTRIMS Forum Insider podcast! :42

The FDA's Complete Response Letter about Tolebrutinib 1:09

Dr. William Conte responds to the FDA's Complete Response Letter 4:09

Share this episode 38:10

Next week's episode 38:30

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I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

Support Jon at WALK MS https://realtalkms.com/walkms

Find out about ABLEnow Accounts https://ablenow.com

JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms

REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review

Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com.

RealTalk MS Episode 440 Guests: Dr. William Conte

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The first coordinated global research strategy to prevent MS has been announced. This week, Dr. Bruce Bebo, the National MS Society's Executive Vice President and Chief Research & Medical Affairs Officer, joins me to explain what MS prevention looks like and how experts plan to achieve this remarkable goal.

We'll also tell you who won the 2025 Barancik Prize for Innovation in MS Research, and we'll explain how their groundbreaking research impacts MS care.

We're sharing the details of a newly announced partnership designed to reduce delays in getting an MS diagnosis and expand access to MS care in Wisconsin.

We'll tell you how an international drug discovery network found that a drug already approved for another condition could also protect nerve cells and promote remyelination.

And we'll share research that shows that AI can accurately predict whether someone newly diagnosed with MS will experience progression independent of relapse activity (PIRA) in the three years following their diagnosis.

We have a lot to talk about! Are you ready for RealTalk MS??!

I'm asking for your support: :22

This Week: Preventing MS 1:47

Dr. Manuel Friese is the winner of the 2025 Barancik Prize for Innovation in MS Research 2:41

National MS Society announces a partnership to improve time to MS diagnosis and access to MS care in Wisconsin 6:26

An international drug discovery network identifies a drug that protects nerve cells and promotes remyelination 8:05

STUDY: AI accurately predicts progression independent of relapse activity in individuals who are newly diagnosed with MS 10:51

Dr. Bruce Bebo explains the strategy behind the global research initiative to prevent MS 14:48

Share this episode 31:31

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I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

Support Jon at WALK MS https://realtalkms.com/walkms

RealTalk MS Episode 424: I'm a Participant in a Clinical Trial for CAR T-Cell Therapy for MS with Jan Janisch-Hanzlik https://realtalkms.com/424

STUDY: In Silico Screening and Preclinical Validation Identify Bavisant as a Therapeutic Candidate for Multiple Sclerosis https://science.org/doi/10.1126/scitranslmed.ads0633

STUDY: Machine Learning Analysis Applied to Prediction of Early Progression Independent of Relapse Activity in Multiple Sclerosis Patients https://onlinelibrary.wiley.com/doi/10.1111/ene.70417

Find out about ABLEnow Accounts https://ablenow.com

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RealTalk MS Episode 439 Guests: Dr. Bruce Bebo

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One of the more confusing aspects of MS is that it can present differently from one person to the next. A research team at University College London may have uncovered a reason for that when they identified two new, and quite different, subtypes of MS.

Joining me to walk us through this discovery and to explain how it may impact MS clinical care is the study's principal investigator, Dr. Arman Eshaghi.

We're also sharing study results that may explain how the Epstein-Barr Virus triggers MS in some individuals.

We'll tell you about the free online fitness and wellness programs for veterans living with MS offered by the Paralyzed Veterans of America.

And we'll explain how the latest entrant in the AI for healthcare revolution can prepare you for your next appointment with your neurologist.

We have a lot to talk about! Are you ready for RealTalk MS??!

This Week: Discovering 2 new subtypes of MS :22

Study results show how the Epstein-Barr Virus may trigger MS 1:20

The PVA is offering free online fitness and wellness classes for veterans with MS 5:45

Claude for Healthcare joins the AI in healthcare revolution 7:03

Dr. Arman Eshaghi discusses his team's discovery of 2 subtypes of MS 9:59

Share this episode 28:15

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I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

EBV Infection and HLA-DR15 Jointly Drive Multiple Sclerosis by Myelin Peptide Presentation https://www.cell.com/cell/fulltext/S0092-8674(25)01495-3

STUDY: Combined Magnetic Resonance Imaging and Serum Analysis Reveals Distinct Multiple Sclerosis Types https://academic.oup.com/brain/article/148/12/4578/8321558

PVA Offers Free Online Fitness & Wellness Classes for Vets with MS https://pva.org/sports-recreation/online-programs

Find out about ABLEnow Accounts https://ablenow.com

Claude for Healthcare https://claude.com/solutions/healthcare

JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms

REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review

Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com.

RealTalk MS Episode 438 Guests: Dr. Arman Eshaghi

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I don't have to remind anyone who listens to this podcast that the cost of MS disease-modifying therapies is obscenely high. And we're not just talking about relatively new medications. Older medications -- some decades old -- continue to increase in price without any rational explanation for why or how. On January 2nd, we lost a true warrior in the ongoing battle to lower the price of prescription drugs when David Mitchell, the founder of Patients for Affordable Drugs, passed away.

I met David in 2018 at a National MS Society Public Policy Conference, and he was a guest on Episode 31 of RealTalk MS. This week, I'm re-sharing the conversation we had in 2018.

We'll also tell you about an international workshop that represents the initial steps in developing a global research agenda to end MS.

We're explaining how AI is about to have a major impact on healthcare.

And we'll share the American Medical Association's brief to Congress, making the case for extending access to telehealth.

We have a lot to talk about! Are you ready for RealTalk MS??!

This Week: We're remembering David Mitchell :22

The first steps toward a global research agenda to prevent MS were just published 1:02

Doctor AI will see you now 5:45

The American Medical Association asks lawmakers to extend access to telehealth 10:27

David Mitchell in his own words 12:41

Share this episode 27:56

Next week 28:16

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I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

Patients for Affordable Drugs https://patientsforaffordabledrugs.org

PAPER: Toward a Global Research Agenda for Preventing Multiple Sclerosis https://journals.sagepub.com/doi/10.1177/13524585251398381

AMA BRIEF: The Case for Permanent Telehealth Policy and Expanded Access to Virtual Care https://ama-assn.org/system/files/issue-brief-telehealth-policy-expanded-access-to-virtual-care.pdf

ChatGPT Health https://openai.com/index/introducing-chatgpt-health

JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms

REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review

Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com.

RealTalk MS Episode 437 Guests: David Mitchell

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Scientists are expanding our understanding of MS at an unprecedented pace. This week, Dr. Leorah Freeman discusses why, as new discoveries and medications enter clinical practice, neurologists and MS specialists should ask themselves 3 important questions when considering a patient's treatment plan.

Dr. Freeman is the Director of the Multiple Sclerosis and Neuroimmunology Center at Dell Medical School at the University of Texas at Austin, where she also leads the MS and Neuroimmunology fellowship program and the MS Imaging and Outcomes Research Laboratory.

We'll also tell you about study results that reveal two distinct biologically-informed MS subtypes.

We're explaining some of the confusing background to the FDA's decision not to approve a disease-modifying therapy that achieved positive results in its Phase 3 clinical trial.

And did we really need a study to tell us that people living with MS fear experiencing a relapse or disease progression? Well, yes. We'll explain why.

We're also reminding you to mail your insurance premium payments and other important documents earlier than you have in the past.

And we're sharing details about the two clinical trials that received $4.1 million in funding as part of the International Progressive MS Alliance Experimental Medicine Trial Awards.

We have a lot to talk about! Are you ready for RealTalk MS??!

This Week: 3 questions your neurologist should be asking themselves :22

Public Service Announcement: How the new rule about postmarks could affect your healthcare 1:16

FDA says it's not ready to approve Tolebrutinib 3:16

Study identifies two biologically-informed MS subtypes 6:29

Study results remind us that people with MS fear relapse and progression 10:09

The International Progressive MS Alliance invests $4.1 million in two clinical trials 14:04

Dr. Leorah Freeman discusses why neurologists need to ask themselves 3 important questions when considering a patient's treatment plan 17:18

Share this episode 33:16

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I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

The Multiple Sclerosis Insider https://themultiplesclerosisinsider.substack.com

STUDY: Combined Magnetic Resonance Imaging and Serum Analysis Reveals Distinct Multiple Sclerosis Types https://academic.oup.com/brain/article/148/12/4578/8321558

STUDY: Fear of Disease Progression and Relapse in Multiple Sclerosis: A Systematic Scoping Review https://frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1680781/full

JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms

REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review

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RealTalk MS Episode 436 Guests: Dr. Leorah Freeman

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We're closing out the year by revisiting the most listened-to episode of RealTalk MS in 2025. And it shouldn't come as a major surprise that this year's most listened-to episode was our review of the largest MS research conference in the world, ECTRIMS.

This episode features the annual conversation that I have with Dr. Bruce Bebo, right outside of the conference center, just minutes after ECTRIMS adjourns. Dr. Bebo is the Executive Vice President of Research at the National MS Society, and each year, he very generously closes out 3 days of nonstop meetings, presentations, and research reviews by sharing his initial thoughts on the announcements and presentations that caught his eye during the conference. When I produced this episode last September, I also wanted to capture a patient's perspective on what can easily become an overwhelming 3 days of presentations, news, and announcements. Kristine Werner Ozug, a member of the RealTalk MS team who lives with MS, joined me right after the conference to share her perspective on ECTRIMS 2025.

We have a lot to talk about! Are you ready for RealTalk MS??!

This Week: ECTRIMS 2025 :22

Dr. Bruce Bebo shares his first impressions of the news and research presented at ECTRIMS 2025 1:22

Kristine Werner Ozug weighs in with an MS patient's perspective on the news and research presented at ECTRIMS 2025 10:35

Share this episode 22:45

Next week on RealTalk MS 23:06

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I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

RealTalk MS at ECTRIMS 2025 on YouTube https://www.youtube.com/playlist?list=PLATxgj1uHpxNoXakZif9TEkKT6mQSwX_9

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RealTalk MS Episode 435 Guests: Dr. Bruce Bebo and Kristine Werner Ozug

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The holiday season gives me the opportunity to indulge in what's become a RealTalk MS tradition. I reserve the last two episodes in December to revisit the most popular conversations that I've had over the past year.

Women represent two-thirds of the MS population. Yet, surprisingly, there isn't nearly enough data related to women's health issues and MS. With an estimated 300,000 women living with MS in the United States who are currently in peri- or post-menopause, researchers have started to focus on how menopause and MS interact, and the best ways to treat symptoms of each. This brings me to a conversation I had last March about managing menopause while managing MS with Dr. Riley Bove. Dr. Bove is a neurologist and the founding director of the Sex and Gender-Enriched (SAGE) Neurology Program at the University of California, San Francisco, and she's considered one of the world's foremost experts on women's health issues and MS.

We have a lot to talk about! Are you ready for RealTalk MS??!

This Week: Managing menopause while you're managing MS :22

Dr. Riley Bove discusses some of the issues facing the estimated 30% of the MS population who are currently in peri- or post-menopause 1:53

Share this episode 20:30

Next week on RealTalk MS 20:51

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I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

RealTalk MS at ECTRIMS 2025 on YouTube https://www.youtube.com/playlist?list=PLATxgj1uHpxNoXakZif9TEkKT6mQSwX_9

Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms

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RealTalk MS Episode 434 Guests: Dr. Riley Bove

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As the year draws to a close, we wanted to share some of the most compelling conversations we've had over the past 12 months. And rather than make my own picks, we went through the hundreds of emails we've received over the past year from the RealTalk MS listener community to see which topics really connected with you.

In this week's episode, you'll hear from four of the top MS experts in the world discussing the subjects you've told me are most important to you.

First, we'll explore aging and MS with Dr. John Corboy, the principal investigator of the largest study designed to answer the question, "Once I turn 60, can I discontinue my disease-modifying therapies?"

We'll talk about remyelination with the winner of the 2025 Barancik Prize for Innovation in Multiple Sclerosis Research, Dr. Mikael Simons.

You'll hear our conversation with one of the world's top MS rehabilitation experts, Dr. John DeLuca, as we tackle one of the most disruptive MS symptoms -- fatigue.

And we'll wrap up this episode by talking with clinician-scientist Dr. Stephen Krieger about the confusion around trying to reconcile the idea of progression independent of relapse activity (PIRA) with a diagnosis of relapsing-remitting MS.

We have a lot to talk about! Are you ready for RealTalk MS??!

This Week: Our most important conversations of 2025 :22

Dr. John Corboy discusses aging and MS 1:07

Dr. Mikael Simons discusses remyelination 10:54

Dr. John DeLuca discusses MS-related fatigue 19:20

Dr. Stephen Krieger discusses how the current course descriptors for MS (relapsing-remitting, secondary progressive, primary progressive) may no longer be working for doctors or patients 26:11

Share this episode 42:10

Next week's episode 42:30

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I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

SIGN UP: Become an MS Activist https://nationalmssociety.org/advocacy

JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms

REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review

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RealTalk MS Episode 433 Guests: Dr. John Corboy, Dr. Mikael Simons, Dr. John DeLuca, Dr. Stephen Krieger

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This special episode of RealTalk MS is sponsored by EMD Serono and is only intended for a U.S. audience. EMD Serono is the healthcare business of Merck, KGaA, Darmstadt, Germany, in the United States and Canada. Please note this episode is only intended for a U.S. audience.

In this special episode of RealTalk MS, Professor Elisabeth Celius and Amanda Montague join me to explore new consensus recommendations for the future of MS care from MS in the 21st Century. We'll hear what experts and people in the MS community think are the priorities to focus on to improve care and help lessen the burden of living with MS.

Professor Elisabeth Celius is a consultant neurologist with a special focus on MS at Oslo University Hospital in Norway, where she is the group leader of the MS Research Group and also conducts epidemiological, genetic, and clinical research.

Amanda Montague is a global thought leader and Interim President & CEO of the Multiple Sclerosis Association of America.

Both Amanda and Elisabeth are active members of the MS in the 21st Century initiative, more commonly known as MS21. MS21 is a Merck KGaA, Darmstadt, Germany, initiative involving healthcare professionals, people with MS, and patient advocacy groups.

To learn more about MS in the 21st Century, please visit www.msinthe21stcentury.com.

Michael Jordan never won an NBA championship until he was paired with the right coach. Then, he won six. Could working with a coach change your MS journey?

In this week's episode, health & wellness coach Amy Behimer explains what health coaching is all about and how working with a coach might impact someone living with MS.

We're also sharing study results that show DMTs fail to manage MS-related pain. Then, we'll explain how a common misconception can lead to the wrong outcome for someone with MS.

And we'll share study results showing that adhering to the Mediterranean or MIND diet improves cognitive performance among people living with MS. We'll also explain why this study raises as many questions as it seeks to answer.

We have a lot to talk about! Are you ready for RealTalk MS??!

Thank you! :22

This Week: What working with a health coach is all about 1:08

Study results show that disease-modifying therapies don't help manage MS-related pain (But are they supposed to???) 2:29

Study results show that adhering to the Mediterranean or MIND diet improves cognitive performance among people with MS (Or does it??) 5:13

Health & Wellness Coach Amy Behimer explains how someone living with MS could benefit from coaching 12:11

Share this episode 39:33

Next week's episode 39:53

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Just copy this link & paste it into your text or email: https://realtalkms.com/432

ADD YOUR VOICE TO THE CONVERSATION

I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts!

Email: [email protected] Phone: (310) 526-2283

And don't forget to join us in the RealTalk MS Facebook group!

LINKS

If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com

DONATE: The National MS Society https://nationalmssociety.org/donate

SIGN UP: Become an MS Activist https://nationalmssociety.org/advocacy

STUDY: Phase 2 Clinical Trial for Moderna's EBV Vaccine and MS https://www.msard-journal.com/article/S2211-0348(25)00573-5/fulltext

STUDY: Mediterranean and MIND Diet Patterns and Cognitive Performance in Multiple Sclerosis: A Cross-Sectional Analysis of the UK Multiple Sclerosis Register https://www.mdpi.com/2072-6643/17/21/3326

JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms

REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review

Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com.

RealTalk MS Episode 432 Guests: Amy Behimer

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