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The Institute for Neuro Immune Medicine’s annual patient conference  occurred a month or so ago. It brought news of some exciting growth in a program that’s taking a comprehensive approach to developing new treatments for ME/CFS.

The mitochondria and energy were highlighted in two talks at the conference.

The mitochondria and energy were highlighted in two talks at the conference.

The blog comes from my sometimes hard to read notes. At times I take riff’s on what the speakers say. These two factors add up to this blog being my personal interpretation of what happened. It may not always reflect what the speakers intended to get across.

Dr. Klimas Talks

“We are moving as fast as we can” Dr. Klimas

Speaking from off-site at a surprise birthday party, Dr. Klimas noted that the Institute For Neuro Immune Medicine at Nova Southeastern has grown enormously in the three years it’s been in existence. Employing no less than 34 people, my guess is that it may be the largest single treatment-research effort focused on these types of diseases anywhere.

The Institute is employing the most impressive multi-pronged “bench to bedside” effort to bring treatments to the fore of any group that I know of. Dr. Klimas, started off, though, by giving us a reality check. The answer or answers to any disorder rarely come easy or quickly. Even with a large effort focused on a precise target, the fight to produce effective treatments for hepatitis B still took thirty years.

wheels of medicine - chronic fatigue syndrome

The wheels of medicine tend to turn slowly.

She didn’t say it was going to take thirty years to find better treatments for ME/CFS. Given the work she and others are doing my guess is that better treatments aren’t that far off – but the wheels of medicine do turn slowly.

[Take the Solve ME/CFS Initiative’s Biovista project begun in 2012. It took Biovista less a year to plough through more than 90,000 compounds, 25,000 clinical outcomes and more than 6,000 biomedical publications – and identify a promising drug combination for ME/CFS. That was apparently the easy part.

The Solve ME/CFS Initiative and Biovista announced in 2013 that a two-drug combination – never before used in ME/CFS – had been found.  Because the drugs are known to be safe but have never been used together before, the next step was an FDA approved proof of concept trial. That expected to talk with the FDA in 2013 and begin a proof of concept trial in 2014. that obviously hasn’t happened yet. The drug combination remains a tightly kept secret.

This is not to slam the Solve ME/CFS Initiative or Biovista. Coming up with a potential new drug combination within a year is fast work!  It’s exciting stuff and it’s taking longer than expected. “Longer than expected” seems to be the norm in medicine. ]

Everything they are doing, Dr. Klimas noted, has been done with the end goal of bringing new treatments to patients.  A Translational Research Unit was specifically created to speed up that process – a process that usually must pass through two steps – cell based and animal studies – before it gets to humans.  From the time a treatment idea is solidified, Dr. Klimas said, it usually takes three years to get to phase I safety trials in humans.

treatments- chronic fatigue syndrome

The focus is on delivering treatments

The Translational Research Unit has a number of  treatment strategies they want to move from the bench (research lab) to the bedside (clinic) this year and in the coming years.

They are currently focused on three sets of trials.

  • An autologous stem cell study that a donor has offered to completely foot the bill for –  is set for this year.
  • Trials are coming out of their computational efforts
  • Continuing work with Ampligen

Clinical studies underway at the NSU include the big CDC multisite study, a Chronic Fatigue Initiative biorepository and microbiome study, a NIH funded microbial translocation, e.g. leaky gut study, the expanded “Good-day/Bad-day” study and a recently funded epigenetics study.

[We’re seeing some nice coherence in the field with these studies.  The CDC multisite study, with its possibility of isolating or starting to isolate some subsets, will surely inform the search for a definition.  The CFI’s microbiome study, Dr. Hanson’s NIH funded microbiome study and the Solve ME/CFS Initiative’s microbiome and leaky gut exercise will start to shed light on this complex and possibly critical area.  The Nathanson epigenetics study at NSU and Patrick McGowan’s Solve ME/CFS Initiative epigenetics are moving forward at the same time as well.]

Giving the CDC Props

As she talked about the Institute’s studies, Dr. Klimas urged some to reconsider their assumptions regarding the CDC. Calling the CDC’s ME/CFS experts study a “fantastic” study she said the CDC was getting a bad rap that it didn’t deserve. The expanded version of the study is going to expand its focus on groups that few research groups have attempted to reach: children with ME/CFS, people who are housebound and people who are just getting sick with ME/CFS.

Business Booming- Infrastructure Catching Up

“Business” is apparently booming. They’re adding an environmental medicine specialist and neurologist. Demand is great. Every time they add a doctor, Dr. Klimas said, their dance card is full within a couple of months. She asked for patience. They’re constantly overstretching ourselves and because of that their infrastructure suffers.

[ Those infrastructure problems have been with them for a long time. Everyone agrees the expertise is there, the tools are there, the empathy is there, but organization has historically been the practices weak point –  a very weak point at times.]

Training

“We’re working very hard to come with training strategies so that wherever you are you can get good help” Nancy Klimas

Obviously they can only do so much in southern Florida. The real answer, Dr. Klimas asserted, comes in training doctors to do treat ME/CFS correctly and they’re developing training modules to do this.

[That could be a very big deal. Giving primary care doctors training modules is an obvious and much needed step to improving care for everybody. Those training modules could also be folded into medical school curriculums.]

Gulf War Illness (GWI) Funding Provides Boost to ME/CFS

 It’s the critical mass we had been hoping for, now have in hand, and are pressing hard for the translational studies that follow.” Dr. Klimas

Funding, of course, is everything – and Dr. Klimas has gotten good funding for Gulf War Syndrome. The Veterans Administration has been impressed enough with the Institute’s GWI work, that they’ve asked it grow a whole service using their approach at the VA. That, in turn, is helping them inform their ME/CFS work.

GWI chronic fatigue

Gulf War Illness funding is helping them put the pieces together for ME/CFS

It’s been about twenty years since a remarkably high percentage of  young, formerly healthy Gulf War Vets (@ one-third) came back sick and stayed that way. Clearly those patients – despite the fact that they’re male and have a different trigger (chemical exposure) – still, with their similar symptoms and disease prognosis, present some sort of model for ME/CFS.

The Institute’s GWI models were the first to indicate how important a role sex hormones play in these disorders. Once the GWI research opened that door, Dr. Klimas was able to parley those results into more funding to investigate why women with GWI and men with ME/CFS get sick. Those are two groups (particularly the second :)) that need more attention.

Dr. Klimas GWI funding has been good enough for her to adopt a very aggressive computational approach that will allow them to quickly from cells to animal models to clinical trials – beginning this year – if I got it right.  A big DOD grant will enable test treatments in animal models of GWI.   One GWI treatment trial was in phase I as of September last year. Others are coming.

Couples Needed!

We all know how tough chronic fatigue syndrome and fibromyalgia can be on relationships. Seeing your partner decline, seeing them be unable to partner with you to do the things you used to do, the financial problems that often crop up, the feelings of helplessness and guilt – on both sides – the issues just go on and on.

Looking for more intimacy with your partner? Try the couples study.

Looking for more intimacy with your partner? Try the couples study.

This couples study – which takes place over the internet/phone – is taking couples from across the country and helping them tackle these issues in an effective manner.

Want to be more peace with your significant other? Want to recover some intimacy that’s been lost? Get on the same page? Enroll in the couples study.  They have only three months left to fill up this study.

(Not filling up an NIH funded study, by the way, is not what the NIH likes to see. It’s important for the Institute that the study gets filled.)

Contact – call 305-355-9200 or email at cfsvideohealth@med.miami.edu if you’re interested in learning more. Delores Perdomo is in charge of the study.

Environmental Medicine

Environmental Medicine is another field that sorely, sorely needs more research. If you’ve ever had chemical sensitivities you know how incredibly impactful they can be.  The Institute of Neuro Immune Medicine is creating a training program for a fellowship in Environmental Medicine to help investigate this area.

Fertile Ground

Renewal

The growth of the Institute indicates Dr. Klimas has found fertile ground at NSU.

Dr. Klimas has clearly found fertile ground at Nova Southeastern and the continued growth of the Institute and the many studies they’re engaged in is encouraging.  Now if we can just get the NIH to start funding some Centers of Excellence  – one of which would surely be Dr. Klimas Institute – we could really get the ball rolling.

Dr. Klimas ended her presentation on a high note – showing a picture who is completely cured. We don’t hear about them much but there are actually quite a few of them out there. No one should give up hope – it can happen.

Then it was onto Gordon Broderick….

Gordon Broderick 

Bro - II

It’s all about conversations!

Broderick is all about trying to capture how the systems in our body work. He proposed to view the interactions between these complicated systems as “conversations”. One immune cell converses with another immune cell, for instance, and has it do “X”.  Factors such as hormones and cytokines engage in conversations with a wide range of immune and other cells.

Broderick modeling efforts indicate that different types of conversations are occurring in the immune systems of people with chronic fatigue syndrome than in healthy people. Some conversations are “louder”; i.e. – they’re more active. Some conversations are taking place between different players.

Betsy Sue, for instance, – who used to talk only to her buddies before  – may be buzzing around now interacting with all sorts of new people (immune cells).  Fred – who never got past the doorman before – maybe in the party now.  Those altered conversations indicate that the immune systems of ME/CFS patients have been fundamentally changed.

Broderick intensifies those conversations more by having ME/CFS patients exercise. Before, during and after that exercise he takes blood at 7-9 time points to determine a couple of things.  He wants to know at one point new players (immune cells) enter into thte conversation and take it in a new direction. He  also looks for choke points – points in the system that are getting overloaded with information. (Picture one person in a corner getting shouted at by a crowd.)  He’s found that natural killer and B cells appear to have been backed into that corner. They’re getting funneled tremendous amounts of information – more than they can handle – and appear to be getting burnt out.

immune network chronic fatigue syndrome

A radically different immune system network in ME/CFS

Whether these changes are triggered by an ongoing pathogen attack, autoimmune processes or some kind of other system reset Broderick did not say. The key thing, though, is that these abnormalities are showing up big-time in his analyses – and that’s good news for a field that’s had more than it’s share of inconsistent immune findings.

Caution Warranted

One of the big questions facing anyone proposing to intervene in this process is whether the altered immune network is protective or the problem. If it’s protecting the patient from a pathogen you might want to actually strengthen parts of it. If it’s simply bollixed up you might want to push it in another direction.

The immune system is so complex, though, that it’s not entirely clear what a healthy immune system looks like. (Mark Davis is studying just this question at Stanford.) It’s not even clear what a normal, healthy immune response to a pathogen like Epstein-Barr virus looks like. That makes it difficult to know if ME/CFS patients system are responding normally or abnormally to a pathogen attack.

ICebergFor all the complexity of the immune networks Broderick has uncovered in ME/CFS, the good news is that they appear to be driven by just a few factors.  Impacting just a few cytokines might allow him to impact large immune networks that are responsible for producing the pain, fatigue, etc. we are experiencing. Broderick’s ability to tease out these factors suggests that relatively small tweaks could have significant effects on our health.

It hasn’t been easy to get this far.  It’s taken supercomputer time – lots of it: 10,000 processors humming 24 hours a day for 7 days to do the calculations needed to understand these networks and perhaps how to tweak them back to normalcy.

Broderick is using his computer models to figure out what cytokine he should address first, how much should he should impact it and when he should go after another one – in order to stop ME/CFS patient’s immune systems from going off like an atom bomb every time they exercise.

He has a list of 16 cytokines all of which may respond to IL-2 modification in ME/CFS. Then there’s IL-15 – an NK cell activator – which keeps showing up.

The combination that’s performed best for him is an IL-2 and IL-17 one-two punch. First you take down IL-2 and then you pump up IL-17. According to his models that should help ME/CFS patients recover from exercise. In fact, his models indicate they might get them very close to having a normal response to it.

Of course immune therapy is no joke. Tweaking the incredibly powerful and complex immune system has to be done carefully. For that reason they’re mostly focused on already available drugs with substantial safety records behind them.

Then there are the sex hormones. Their role in modulating the immune system  has turned out to be surprisingly significant. Broderick’s is trying to put it all together.

His models right now are suggesting he can get the system back to normal – for a while – but then the effect fades.

The Programmer!

The next speaker – the chief programmer of the Pegasus supercomputer at NSU – began by expounding on the stunning capabilities of his machine.  He can do what used to take a decade in a week. He can plug a patient population’s data into the computer and run hundreds of thousands of simulations on it.

It’s this kind of incredibly thorough approach that apparently gives Broderick so much confidence in his data. The data is apparently run again and again and again in every conceivable formulation..

Big, big, big Data

Big, big, big Data

The data suggests that ME/CFS patient’s have become trapped in a suboptimal homeostatic state. Some external stressor – an infection, stress, an injury, a toxin – some event or events – pushed their systems so far out of normal that they can’t find their way home.

The question of how to push them back into normalcy is complicated by the complex hormone-immune interface in the body.  They’ve found five different stable homeostatic states in men and eleven in women.  Each of these states resists change and only one apparently reflects optimal health.

They’re beginning to get a grasp on what it takes to move a typical ME/CFS patients  homeostatic state back to normal.  They’ve identified several treatments which, if given in the right amount, at the right time, in the right order, returned the system to normalcy (health) one out of two times. (It took the supercomputer a hundred thousand runs on a million person patient pool to come up with that treatment protocol.)

Calling this stuff “cutting-edge” almost makes a mockery of that word.  “Revolutionary” is a better descriptor. How this disease with so little funding got access to this kind of potentially revolutionary technology is anyone’s guess. Broderick, in fact, almost left the field a couple of years ago. A chance meeting with a veteran who expressed his profound thanks for Broderick’s work caused him to stick with the field.

Chance and the human element [plays a big role in all this. What causes Lipkin to take an interest in ME/CFS? Who could have predicted that uber- geneticist and technologist Ron Davis’s son would get ill – pushing him into the field?

Now they’re adding drugs to the mix. They just put in a grant to fit the pharmacokinetics of repurposed drugs into the computer – how fast they break down, what they effect, etc. – into the computer.

It’s a brave new world.

Richard Deth –  Oxidative Stress, the Mitochondria and Fatigue

Deth believes the precipitating events (infections, stress, toxins) that trigger ME/CFS produce insults to our oxidative stress systems.

Antioxidants

Free radicals are also a by-product of ATP (energy) production.  Antioxidants mop up the free radicals but if antioxidants such as glutathione (GSH) are low then oxidative stress rates are going to go up. That means increased levels of electrically charged particles (free radicals) that go around tearing into and tearing up the membranes of the cells around them in their effort to achieve balance.

Attacking  cellular membranes.

Attacking cellular membranes.

GSH, the key antioxidant in the body protects the body in two ways. One, it reduces or tames free radicals – a process that causes it to become oxidized. The key glutathione measure to look at is the ratio of reduced to oxidized (used up GSH). It should be from 20-30/1. Anything less indicates the antioxidant system is not keeping up and increased levels of oxidative stress are present.

Two, if oxidized levels of GSH become too high it will bind to the mitochondria shutting them down. Because dysfunctional or damaged mitochondria can produce very high levels of free radicals this GSH “shutoff valve” is an important way of eliminating both a source of oxidative stress and poorly functioning mitochondria.

The end result of high levels of oxidative stress is termination of the energy production process – and fatigue.

Rich Von Konynenburg

rich von konynenburg

RIch made a dent in Deth’s thinking

Deth credited Rich Von Konynenburg with making a major impact in his thinking.  He noted that Rich Von Konynenburg and Nathan found 50% lower GSH/reduced GSH in ME/CFS patients. When they used the Yasko protocol (B12 and folate) to increase GSH levels and methylation, energy, well-being and mental clarity went up.

[Konynenburg’s protocol was founded on these foundations (from the treatment study):

  • A stressor (physical, chemical, biological, and/or psychological/emotional) places demands on glutathione
  • Glutathione levels drop, producing oxidative stress, interfering with the intracellular metabolism of cobalamin (vitamin B12) and allowing toxins to accumulate.
  •  A functional deficiency of vitamin B12 is produced, resulting in lowering of methylcobalamin and adenosylcobalamin.
  • Lack of sufficient methylcobalamin inhibits the activity of methionine synthase, placing a partial block in the methylation and folate cycles.
  • Methylfolate drains from the cells into the blood via the “methyl trap” mechanism.
  • An interaction (vicious circle) is established between the partial block in the methylation cycle and glutathione depletion, and the disorder therefore becomes chronic.
  • Dysfunctional detoxication and immune systems allow toxins and infections to accumulate over time

Konynenburg believed that

“treatment should be directed primarily at increasing the activity of methionine synthase. The resulting normalization of the methylation cycle, the folate metabolism, and glutathione levels will restore function to the immune system and the detoxication system as well as to a wide range of other parts of the overall biochemistry.”

[Von Konynenburg and Nathan’s 21-person study made in into the Townsend Report but not into a medical journal. The study was successful but lacked rigor, probably because of lack of funding, in some areas.  For instance, they used an index of referenced laboratory measures for healthy people as controls instead of healthy controls.

Study results with regard to GSH depletion in ME/CFS are actually very mixed. While oxidative stress is consistently elevated in ME/CFS, most studies have found normal GSH levels in ME/CFS (normal glutathione peroxidase, normal reduced GSH levels, normal GSH levels, increased GSH.)

Shungu’s compelling findings probably provide the best evidence that GSH depletion is important in ME/CFS.  Shungu found that reduced levels of GSH in the brain were highly associated with symptom severity both in ME/CFS and depression and were negatively correlated with high lactate levels. They suggest high levels of oxidative stress and low antioxidant levels could be shutting down ATP production in the brain. ]

Diet

Diet can play a role as well. Deth explained that the peptides released when you digest gluten (from wheat) and casein (from milk) activate opiate receptors and block the transporter that brings GSH into the cell. As cellular GSH levels fall, methylation is impacted. First it goes up and then it goes down – negatively affecting dopamine production.

Dopamine turns on a receptor that appears to play a central role in producing focused attention. Alterations in dopamine receptor are a risk factor for ADHD (which is probably increased in ME/CFS and FM).

Meanwhile, opiates released in the gut rob the mitochondria of cysteine – a foundation for antioxidant production– reducing antioxidant levels and possibly setting the stage for inflammation in susceptible individuals.

Deth credits this process with the reduction in gut, neurological and immune symptoms that some people experience when they go off milk and wheat products. [Dr. Peter Rowe has found that if his adolescents with ME/CFS are sensitive to milk that getting them off it is crucial to seeing improvement with other treatments. ]

Deth noted that he is not a medical doctor, but suggested that nasal administration of methyl B12 can increase glutathione levels in the brain.  Since Shungu has found that reduced glutathione levels in the brain are associated with symptom severity increasing them is probably a good thing.

Jon Kaiser- Synergy Trial

Kaiser’s focus on boosting the mitochondria and immune system in ME/CFS fit in well at this point.

jon kaiser on synergy and chronic fatigue syndrome

FIrst he tweaked supplements for HIV/AIDS patients, then he did it for people with ME/CFS.

His work in this area dates back decades to the HIV epidemic. The HIV drugs were a huge help but disturbing side effects – many of them due, he thought, to oxidative stress induced mitochondrial damage – began to show up after about five years. He developed nutritional ways to reduce the oxidative stress and improve mitochondrial functioning and it worked.  Similar to Deth, he asserted that the number one symptom of low antioxidant levels is fatigue.

Kaiser believes mitochondrial dysfunction is one of the only hypotheses that ties all the symptoms in ME/CFS, Gulf War Illness and similar disorders together.

He noted that a small but apparently well-done study recently suggested that GWI, whatever else it is,  may be a mitochondrial disorder as well. Golumb et al’s finding that “mitochondrial response to exercise (PCr-R) was blunted in GWI patients suggested GWI was a mitochondrial disorder. The muscles and brain are particularly affected in GWI because they are the most energetically challenged tissues in the body.

[Phosphocreatine findings including phosphocreatine recovery in ME/CFS have been mixed with most studies not finding significant problems. It’s not clear if the same test done in the GWI study was used, though.

Ironically and tragically Golumb  suggested that Department of Defense’s attempt to protect the troops using high numbers of multiple vaccines, anthrax vaccine, pyridostigmine bromide nerve agent pretreatment pills, pesticides and insect repellents, and permethrin-impregnated uniforms played a role in the wide-spread health collapses that occurred. Throw heat, depleted uranium tanks/munitions, chemical agent resistant coating paint, oil fires and battle conditions into the mix and you have an unwitting experiment on a grand scale of just how many toxins even a young, healthy body can handle at one time. ]

Kaiser noted that two muscle studies and Shungu’s three studies suggest that ATP problems are present in ME/CFS. The same process that produces muscle cramping during exercise, he believes, maybe reducing blood flows to the brain in ME/CFS.

He used n-acetyl cysteine (NAC) – a critical component for him –  to improve GSH levels in his HIV/AIDS patients. Using acetyl l carnitine and alpha lipoic acid to increase energy increases oxidative stress, but animal studies indicated that adding NAC to clean the free radicals up  makes a huge difference. (He also suggested that acetyl-l carnitine works better than L-carnitine and that it works better at low doses.)

A 2006 placebo-controlled, double-blinded trial indicated that his micronutrient formula boosted immune functioning in HIV/AIDS patients.

Mitochondria - chronic fatigue

Those mitochondria – they’re pretty complex. Kaiser reported it took him quite some time to come up with a formulation that worked

After that he thought he’d give it a try with ME/CFS. [Got to be easier than AIDS right? Wrong!] After the rapid, positive effects he’d seen in HIV/AIDS did not materialize in his ME/CFS patients, he started rearranging the formula – adding other nutrients, hormones, etc..

It was not until he tried something he’d held off on that something clicked in his patients bodies. Kaiser worried  that central nervous stimulants would be over-simulating but instead, in combination with mitochondrial and immune factors, they proved to be simply energizing. .

Energy level, alertness improved rapidly followed by a gradual improvement in functional status. Some patients had incredible results.

After an open-label proof of concept trial produced good results (one indicator of symptom severity approached normality) he moved on, and designed a double-blinded placebo controlled multi-center trial using ME/CFS experts. We are just a couple of months away from results of the trial but he could report that the safety profile was good.

If the results are positive the FDA is the next step. If you want to get the results as they come out send your email address to ask@KPAXpharm.com

Mitochondria

The mitochondria appear to be indeed catching on. Deth and Klimas have written a grant proposal  to help them develop a better understanding of the role the mitochondria play in GWI. They will do same for ME/CFS.

A donor has helping the Institute for Neuro Immune Medicine buy a machine to analyze the mitochondria better. We just had a study suggesting the mitochondria play a role in fibromyalgia. Another study suggested they play a role in post-chemotherapy pain. The Chronic Fatigue Initiative may be heading for the mitochondria as well.

Q and A

Glutathione

Deth and Kaiser agreed that NAC is the best way to supplement glutathione. Deth recommended using liposomal varieties of NAC.  IV treatments such as a Myers cocktails can help but Kaiser prefers to use the cheaper oral methods.

Kaiser warned that you can throw your system out of balance by taking too much of one supplement. He’s found that his formula has worked well.

 mitochondrial support me/cfs

Part of the formula

His drug/supplement combination includes Ritalin 5 mgs with breakfast and lunch plus 4 tablets of the immune formula. By 8pm everything is out of your system and you’re ready to sleep – which has come easier in his patients. In response to a question he stated he would only increase the Ritalin to 10 mgs/day if a patient saw response after the first couple of weeks.

Every patient may not, in fact, need Ritalin. Kpax’s Immune and energy contains a small dose of caffeine (60 mgs). It’s only about 25% less potent than Ritalin version. Some people have had excellent results. [I am trying the Fatigue Trial Pack. I have had good results. In my hypersensitive state I only need  1 and 1/4 tables not four or five to get results.]

The Ritalin in the Synergy formula “pushes” the system a bit and Dr. Klimas agreed that sometimes you have the push the system a bit – with small amounts of exercise or other factors – to get it to respond.

LDN and Immunovir

An LDN and Immunovir question brought a response from Dr. Klimas that (their in-house) study has shown that it improves NK cell functioning….They are trying to get a grant to get a full-blown study going. She warned that you often have to start very low with LDN and that it may take 4-6 months to see improvement.

Animal Hormones

Both Kaiser and Klimas avoid animal hormones. Klimas suggested anything could be in them and noted that hormones suppress things. If you take an adrenal hormone it will suppress your adrenal hormones. “Don’t do that” she said.

Klimas again asked patients to have hope. She does see home runs and some people do get completely well. [I have a database of about a hundred people who have.]

On the treatment end let’s note several possibilities that have cropped up

  • the Synergy trial
  • the Open Medicine Foundations Folate/MTTHR trial underway
  • the Rituximab trial
  • the two-drug combo trial from Solve ME.CFS and Biovista
  • the INM’s stem cell trial
  • the continuing Ampligen trials
  • the trials that will come out of the INM’s models

And probably more…

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