Serious Infections Greatly Increase Your Risk of Becoming Depressed, Which in Turn Undermines Your Recovery From Disease or Surgery

Surgical site infections are the most common healthcare-associated infections accouting for almost 1/3 of all HAIs

The risk of developing a mental disorder, especially depression and even bipolar disorder, is 62 percent higher than in the general population if you have suffered a serious infection, according to a landmark study (3.56 million people tracked over 33 years ending 2010) published last year in the Journal of the American Medical Association.

According to the lead researcher Michael Benros, MD, the depression overlaps with the infection and will even pick up where the infection leaves off. ”We know that some of the symptoms that you get with infections are very similar to those you get when you’re depressed,” he says. “You get tired, lose your energy and your mood is affected. This [study] indicates that some of these symptoms remain after the infection has passed.”

The reason? It’s all in your head – literally. Infections affect the brain, says Benros, because infection causes inflammation which produces antibodies and other substances. They cross the blood-brain barrier and disrupt brain chemistry which results in the depression. In other words it’s “real,” in the sense that it has nothing to do with the patient’s character or willpower as is often thought: once your brain chemistry gets hijacked you’re forced to go along for the ride. Should the depression continue the person can slide into “health-damaging behaviors,” such as poor nutrition, hygiene, and sleep habits, and increased smoking and alcohol consumption.

And what effect does depression have on your surgery? It’s a double whammy: it slows healing of the surgical wound and at the same time it undermines your immune systems ability to control the infection itself. That’s why these patients suffer longer hospitalizations, more hospitalizations, more readmissions to the ICU, more reoperations, and more deaths.

The Need for Universal Pre-Surgical Decolonization: Overcoming the Disadvantages of Antibiotics

Up to 30% of patients are carriers of Staph aureus. Colonization rates of the serious antibiotic resistant version of Staph aureus, known as MRSAid (one of the 3 major superbugs), range from 2% in Canada to 80% in Shanghai Ordinarily, these pathogens do not impact patients until they are weakened by illness or surgery. Post-surgical infection is a risk for patients colonized with this pathogens and therefore has led to the need for removing or reducing the bacterial load carried around by these patients just prior to surgery.

MRSAid ApplicationDisinfecting the skin prior to surgery has long been a standard of care. Whether with iodine, chlorhexidine washes or other antiseptic surfactants, reducing the bacterial load on the skin surface has been established as an important mechanism to control the rate of post-surgical infection. The nose, which is a warm, moist environment ideal for bacterial growth, however had been difficult to decolonize.

In several studies, the nose has been identified as the key reservoir of Staph aureus and MRSA, representing 40% of the bacteria load in one small area. Because the nose is not washed on a regular basis, unlike other body parts, Staph aureus can easily flourish in the nose and become a source of contamination for other body parts. Because of delicate mucosal tissue and the presence of cilia in the nose, the antiseptic washes used for hardier skin surfaces are not appropriate for use in the nose. Instead, nasal decolonization has been done by topical antibiotics such as mupirocin.

Topical antibiotics have 3 significant disadvantages that have resulted in many infection control experts rejecting pre-surgical nasal decolonization protocols. With sub-optimal patient compliance, infection control experts fear the resulting antibiotic resistance formation brought about by sub-optimal doses of antibiotics that occur when patients stop mid-way through their antibiotic treatments. Poor patient compliance, despite advisories about the severity of MRSA and Staph aureus infections, is the leading disadvantage of antibiotics.

The problem is the inconvenience and unpleasantness of antibiotic creams in the nose. Patients are known to dislike the thick viscosity of mupirocin and often do not comply with the 3 times a day for 5 days treatment protocol. Incomplete doses of antibiotics leads then to antibiotic resistance which in turn adds to, not subtracts from, the risks already present with patients colonized with Staph. This is the primary reason why many hospitals have not opted for nasal decolonization protocols despite the 30-40% reductions in surgical site infection rates demonstrated in clinical trials.

The second disadvantage of antibiotics is the time required to decolonize. On average, decolonization using topical antibiotics requires about 5 days which implies that patients need to be screened and identified early enough for the efficacy of antibiotics to kick in.

The third disadvantage of antibiotics, however, is the inconvenience to patients and the costs to the health care system to culture for and identify Staph aureus and MRSA carriers.  Because of antibiotic resistance concerns, only carriers of Staph and MRSA are given nasal decolonization therapy. New rapid diagnosis technologies have emerged, but prior to Photodisinfection, there was little acceptance of these rapid diagnostics because antibiotics, the decolonization remedy, still required 5 days treatment for effect. The saving of 2-3 days prior to a 5 day treatment protocol did not justify, to many, the additional cost of same-day rapid diagnosis.

Photodisinfection eliminates the disadvantage of antibiotics thereby allowing for universal nasal decolonization. Because there is no resistance formation, it is safe for all surgical patients, even if they are not carriers of Staph aureus or MRSA. Not having to spend the time or cost to identify carriers of Staph is an enormous benefit to work flow integration and patient compliance rates. Because the Photodisinfection process is instant, decolonization can occur at the hospital in the minutes before a surgery. Because it is painless and effective and only lasts 5 minutes, the treatment is well tolerated by patients and compliance can exceed the 90% range as was the case in the Vancouver General Hospital study (94%)7.

Photodisinfection is the disruptive new technology that finally enables health care providers to universally protect their surgical patients. Universal pre-operative decolonization protocols can materially impact patient safety outcomes and should therefore, in my view, be integrated into standard of care.

Universal Decolonization Protocols: Treating Everyone Before Surgery to Avoid Infections Now Possible


MRSAid Nasal Decolinization at Work

The Journal of Hospital Infections recently published the results of a year-long study conducted at the Vancouver General Hospital in which a 40% reduction in the rate of surgical site infections was demonstrated using a universal decolonization protocol to remove the potentially harmful bacteria in the nose and on the skin.  This is a significant clinical outcome that will influence the future of infection control in health care facilities. This is not the first time that decolonization of the nose and skin was deployed; in fact, there are many such studies that have demonstrated a 30-40% reduction in surgical site infection rates. What makes this study unique, is that this is the first time that all pre-operative patients, and not just those identified as having been MRSA, or even Staph aureus (MSSA) carriers, were decolonized whether they were carriers or not.

The unique feature of this nose/skin decolonization trial was the Photodisinfection treatment in the nose. Photodisinfection is a simple 2 step light based treatment that destroys potentially threatening bacteria in 5 minutes just prior to surgery. Because Photodisinfection is not an antibiotic and does not generate resistance, all patients are candidates for nasal decolonization treatment instead of only those screened and identified as Staph aureus carriers. Because Photodisinfection is so effective and destroys bacteria so rapidly, patients can be treated just prior to surgery by a health care professional instead of relying on patient compliance days before the operation. Lack of resistance concerns and lack of patient compliance requirements finally provide the health care provider with stress free surgical site infection prevention that can be universally applied to their patients.

We Have Hope: MRSAid Technology Significantly Reduces Infections Caused by Surgery

Dr. Elizabeth Bryce led the research team that changed the way Vancouver General Hospital prevents surgical site infections

The Journal of Hospital Infection is the official journal of the prestigious London, England-based group, the Healthcare Infection Society. We are proud to announce that just this week, The Journal published Dr. Elizabeth Bryce’s year-long study at the Vancouver General Hospital on the effect of MRSAid on surgical site infections. But let’s begin at the beginning …

Undergoing major surgery is tough stuff. Having undergone spinal surgery I can speak from experience. The whole ordeal is fraught with anxiety and whether it works or not is life-changing, not to mention potentially life-saving. When you get out of the OR and wake up in a fog of pain and anesthetic you immediately have just one question: Did it work? When you’re told it has, it’s like a comfort drug rushes through you and for the first time since you were told you needed the operation – in my case 5 weeks – you are able to relax.

But here’s what I can’t imagine: being told that you’ve contracted an infection in the surgical wound. You’re already physically and psychologically broken down. To have to cope with an additional injury at the very place in your body that has already given out would be – devastating.

Surgical site infections (SSIs), however, are common. They represent almost 1/3 of all hospital infections and affect about 5% of surgery patients. That’s a ton of people given that about 16 million operative procedures are performed each year in acute care hospitals in the United States.

Hospitals have a standard way of preventing SSIs: cleaning the skin with an antiseptic, usually chlorhexidine (CHG) wipes, and/or nasal decolonization (a lot of germs live in the nose) with an antibiotic ointment, usually mupirocin.

But there are 2 problems with this: (1) antibiotics are increasingly losing their effectiveness, so much so that the World Health Organization and others consider antibiotic resistance to be a worldwide crisis, and (2) compliance: you have to apply the antibiotic over a period of 5 – 7 days and studies show that outpatients forget or otherwise just don’t do it; and if you’re in the hospital it takes up valuable nursing time to get it done.

So Canada’s Vancouver General Hospital, the second largest hospital in the country, decided to try something different: they replaced the antibiotic ointment – which causes both the resistance and compliance problems – with photodisinfection therapy (PDT). PDT is a promising antimicrobial strategy that uses light energy to activate a colored dye applied inside the nose (where the antibiotic ointment was applied) which in turn kills the germs (see Figure 1 at the back of the study for a photo display of how it works).

The VGH study, led by Elizabeth Bryce, MD, and reported just this week in The Journal of Hospital Infection, did this over a 1 year period with 3068 cardiac, orthopedic, spinal, vascular, thoracic, and neurosurgical patients. They used PDT and CHG wipes in the surgery holding-area in the 24 hour period before surgery (vs the protracted 5 – 7 days with the antibiotic ointment). The researchers compared the rate of SSIs using this procedure, versus the SSI rate over the previous 4 years using the former CHG-antibiotic ointment procedure, which involved some 12,387 patients.

The result? They found a “significant reduction” in the SSI rate with this procedure versus the former one. The greatest decreases in SSI rates were found in orthopedic and spinal patients: a 42% reduction in SSIs was realized, the majority which would have been hard-to-treat deep/organ space infections.

But it was something else in the study that caught my eye: “Importantly,” they say, “immediate [decolonization] ensured a very high degree of compliance (94% of patients) without interrupting normal workflow. Intranasal PDT took approximately 10 min compared with five to seven days with traditional mupirocin. In fact, the nurses were able to treat 1,912 patients in addition to those targeted for intervention.”

From a patient and staffing point of view that’s huge because the researchers, to their credit, are talking about the effect of this procedure on real-world medicine: i.e. PDT not only fits the hospital environment, it actually helps nurses do their jobs.

While my surgeon showed up once or twice a week after the surgery, it was the nurses who were my lifeline: they managed my pain, they dealt with my fears, and they helped me take my first steps again.

But that was decades ago. These days, nurses increasingly find themselves overwhelmed by their workloads. For example, an investigation conducted last year by the CBC’s Fifth Estate found that nurses “Carry out a dizzying array of … tasks during each shift … Nearly 40 per cent told us they feel burnt out to a high degree. Research shows nurse burnout is associated with risks to patient safety. Nurses we heard from also expressed fear that stress is leading to mistakes.”

A recent opinion piece in the New England Journal of Medicine also argues for more technology to deal with infection control: “Infection prevention eliminates the need to use antibiotics. Traditional infection-prevention efforts must be buttressed by new technologies that can more effectively disinfect environmental surfaces, people, and food.”

The Vancouver General Hospital has done just that and they continue to use PDT as part of their universal pre-operative decolonization protocol.

This study was reported previously at the International Conference of Infection Prevention and Control, and awarded first place at the Innovation Academy, Geneva, Switzerland, June 2013.

Tomorrow morning around 6:35, Carolyn Cross, the head of the company who produce the PDT technology will discuss its applications and the VGH study on a Vancouver radio program.

Here is a video of PDT at VGH:

Hospital MRSA-Control Policies: We May Have It Wrong

MRSA (red) on the microscopic fibres of a wound dressing

Here’s the problem: More than 200,000 patients get infections every year while receiving healthcare in Canada; more than 8,000 of these patients die as a result. Methicillin-resistant Staphylococcus aureus is the most common cause of serious hospital-acquired infections. Its rate increased more than 1,000% from 1995 to 2009. In the United States, MRSA numbers are the same, population adjusted.

Here’s the decades-old solution: Hospitals commonly screen patients for nasal carriage of MRSA. If you test positive, you’re isolated from other patients and treated (if infected) or decolonized (if you’re a MRSA-carrier but not yet sick). In the US, nine states mandate such screening.

Screen and treat seems reasonable enough. However, studies are trickling out suggesting that this is not the way to do it. Instead, they say, decolonize everyone at admission, or at least the “at risk” admissions such as surgery and ICU. This is called universal decolonization.

The prestigious New England Journal of Medicine published a study last summer that found universal decolonization of patients in the ICU was the “most effective strategy” versus screen and treat, or screen and decolonize. Its effectiveness was due to it “significantly reducing” MRSA-positive clinical cultures, and bloodstream infections from any pathogen. The reason, researchers say, is this method gets MRSA as well as other kinds of germs, it gets them right away at admission thus preventing spread to others, and it’s more easily incorporated into regular hospital procedures.

Just today, the British medical journal, The Lancet, published a study (unfortunately, subscription required) saying there’s insufficient evidence to support screening and isolating infected patients. In an interview with the BBC, one of the researchers, Gerd Fatkenheuer, said: “In the haste to do something against the rising tide of MRSA infection, measures were adopted that seemed plausible but were not properly assessed, bundling the effective and harmless with the ineffective and harmful.

With respect to isolating patients he said they found an unintended consequence: “We know for example that isolating patients can result in anxiety and depression and fewer visits by doctors and nurses,” thus lowering the overall standard of care.

And in Canada we have a real-world example of universal decolonization that bears out what the studies are saying. Over a 12 month period, the Vancouver General Hospital universally decolonized all of their 5,000 surgical patients. They found a 39% reduction in the number of surgical site infections, readmissions due to SSIs declined from 4 to 1.25 cases per month, and VGH saved more than $1 million in costs associated with treating patients who develop SSIs.

Catching Up With Florence Nightingale

"Don't tread on me Dude - haven't you read the latest science?"

In 1995 there were 189 cases of MRSA in Canadian hospitals; by 2012, there were 7,206.

In response, The Chief Public Health Officer’s Report on the State of Public Health in Canada (2013), recommends that we re-focus our efforts on prevention strategies; namely, better hand hygiene and improved hospital cleaning.

Obviously the more bugs we kill the safer we’ll be: that’s just common sense — right?

Not so fast, say researchers at the Hospital Microbiome [i.e. bug] Project, whose mandate is to reduce hospital-acquired infections. They say that not only is this approach not fixing the problem, it’s actually making it worse. In other words, that insane rise from 189 MRSA cases a year to over 7,000 – that’s on us.

The thinking is this. Bad bugs don’t exist in isolation. Rather, they exist as a huge minority among hundreds of millions or even trillions of other bugs. Our weapons of destruction – things like antibiotics, bleach, or hand sanitizers – are not laser-guided missiles, they’re like atomic bombs that wipe out almost everything around. Who doesn’t get slaughtered? The bad guys mostly; specifically, the bugs who have already developed resistance to our drugs, etc. – that’s what resistance means, the ability to survive it all.

So once you have a hospital battlefield with a ton of dead harmless and even helpful bugs, guess what happens next? The resistant guys that remain standing reproduce like crazy. That’s because there’s no one left to compete with them for living space and food – as our antibiotics, etc., have killed-off the competition.

Jack Gilbert, PhD, who‘s in charge of the Hospital Microbiome Project puts it this way:

“For the past 150 years, we’ve been literally trying to just kill bacteria. There is now a multitude of evidence to suggest that this kill-all approach isn’t working.” (For example, here and here; and in this popular New York Times essay, “We Are Our Bacteria.”)

Thus, hospital-acquired infections are being driven not by the existence of harmful microbes but by the absence of helpful species.

"Just open the window."

So the idea is to replace search and destroy with “growing a garden.” You do that by manipulating such things as hospital air temperature, humidity, light intensity, room air and CO2 concentrations, ventilation, and so on, thus cultivating an ecosystem of bugs beneficial to the patient. It’s just like tending a garden: by manipulating light, water, and soil conditions you influence the health of the plant; here, you influence the health of the patient by “weeding out” the bad bugs by, especially, growing and nurturing the good ones.

There’s a more traditional way of putting this paradigm shift in thinking:

“In watching disease … the thing which strikes the experienced observer most forcibly is this, that the symptoms or the sufferings generally considered to be inevitable … are very often not symptoms of the disease at all, but of something quite different – of the want of fresh air, or of light, or of warmth, or of quiet, or of cleanliness, or of punctuality and care in the administration of diet, of each or of all of these.” - Florence Nightingale, “Notes on Nursing,” 1860.

It seems we may finally be catching up with her.

MRSA Ends the Career of NFL Player Carl Nicks

Carl Nicks: When he was King

At just 29 years of age, at the height of his physical powers and recognized as the best at his position in the game, MRSA finally did to Tampa Bay Buccaneer all-pro guard Carl Nicks what no opponent could – it ended his career.

On Friday, Mr. Nicks made this announcement: “I’d like to thank the Buccaneers organization for working with me as I have attempted to get myself back on the football field. However, after careful consideration, I have made the decision to step away from the game. This was by no means an easy decision, but I believe that it is what is best for me and my family as well as the Tampa Bay Buccaneers.”

Tampa Bay GM Jason Licht said: “I know this has been a difficult time for Carl and his family, but we respect his decision and thank him for his effort in trying to get back on the football field.”

It all started so innocently. During training camp last August Carl’s foot blistered and became infected. He took antibiotics that seemed to work but after just 2 games – the last he will ever play – MRSA returned. The infection spread to the nearby bone and that required surgery.

But that never did the trick either. Media reports characterized Carl’s attempted return much like this one: “Though Nicks was never seen during the voluntary portion of the Bucs’ offseason work this year, there were signs that he was hoping to return. He was limited to jogging and rehab drills. He said he was prepared to live with the pain and nerve damage the rest of his life.”

There are tens of thousands of MRSA stories like this just in the US alone. According to the Centers for Disease Control and Prevention, MRSA is a “serious threat” to public health because it causes about 80,461 severe infections and 11,285 deaths a year.

We have been following Carl Nick’s story since last November beginning with The Hercules Factor, and this January we posted a blog titled Has MRSA Ruined an NFL Career?

On Friday we got our answer.

The Bank Robbery Rule

Mr. Sutton's approach to getting in and out of this place ...

In his luncheon address at the National Press Club in Washington, DC, this Tuesday, Tom Frieden, MD, Director of the Centers for Disease Control and Prevention, put this question to the audience:

“What do these 6 organisms have in common besides the fact that they’re all infectious diseases? MERS [a viral-caused respiratory illness that kills about 1/3 of the people who get it], Ebola [viral-caused internal bleeding], measles, multi-drug resistant TB, C. difficile [gut bacteria that causes severe diarrhea], and CRE [the new ‘nightmare bacteria’ that kills half the people who get it].”

The audience was stumped so he offered a clue: “It has to do with how they spread,” he said. Still, no one got it.

The answer is: “They’re all – very importantly – spread in hospitals. We [hospital personnel] can be part of the problem if we’re not careful,” he said.

Tom Frieden was being candid about a subject we’ve addressed many times before, namely, that the hospital is an inherently dangerous place. For example, we’ve reported that: there is sometimes a surprisingly high rate of infection carried by hospital staff; Hospital-Acquired Infections cause more deaths in Canada each year than breast cancer, HIV/AIDS, traffic accidents, and homicides combined; lab coats, stethoscopes, smartphones and tablet computers used by doctors and nurses are magnets for bad bugs; on the high rate of physician non-compliance with hand hygiene protocols; hospitals are built in such that they aid and abet the spread infections, and, finally; the ease with which hospital cleaning procedures can actually spread pathogens instead of getting rid of them, summed up in this superb and highly infectious video, THE BUG ZONE, made by, and featuring, some creative hospital staff in Winnipeg, Canada.

... may help you in your approach to getting in and out of this place.

When legendary bank robber Willie Sutton was captured by FBI agents in 1934 they asked him why he robbed banks. He said, dryly, “Because that’s where the money is.”

As banks are to money, hospitals are to germs, and therefore germs that become, or are already, resistant to antibiotics. Infectious disease specialist Brad Spellberg, MD, explains:

“I do think that people need to understand that the hospital is an inherently dangerous place and it’s not because hospitals are dirty or doctors are lazy or anything like that. Think about it this way. You’re taking the sickest people in society, crowding them into one building, tearing new holes in their bodies that they didn’t use to have by placing plastic catheters in their bloodstream, their bladder, putting tubes into their lungs that can breathe for them, and we’re using very large quantities of antibiotics to treat infections. So that’s a perfect breeding ground to generate antibiotic resistant bacteria.”

There’s a saying among hospital physicians: “The longer you stay the longer you stay.” That is, because hospitals are so full of germs – susceptible and resistant – the longer you stay the greater the risk that they will get hold of you and make you sick, or worse.

So as it turns out, the trick to a successful hospital stay is much the same as the trick to a successful bank robbery – get in and get out as quick as you can.

Hospital Elevator Buttons vs. Toilet Surfaces: Guess Which One the Bacteria Prefer?

Don't touch that!

In hospitals, you’re more likely to find bacteria growing on elevator buttons than on toilet surfaces – for goodness sake!

This is according to a study just published by Canadian researchers who went to 3 major Toronto hospitals and found that 61% of elevator buttons (interior and exterior) vs. 43% of toilet surfaces had bacteria on them. The bugs they found the most were staphylococci and streptococcus bacteria (as in strep throat), in that order. Significantly, the prevalence of bacteria in all hospital elevators exceeded what you find in the community.

While the bacteria found in this study were not antibiotic resistant, the researchers do point out that the white lab coat, computer keyboards, cellphones, stethoscopes, scotch tape, ultrasound transducers, and X-ray equipment have all been identified as sources of hospital-acquired infections in other studies.

These findings illustrate the broader principle that hospitals are an inherently dangerous place. Infectious disease specialist Brad Spellberg, MD, professor of medicine at the Harbor-UCLA Medical Center in the US (who was not involved in the study) puts it this way:

“I do think that people need to understand that the hospital is an inherently dangerous place and it’s not because hospitals are dirty or doctors are lazy or anything like that. Think about it this way. You’re taking the sickest people in society, crowding them into one building, tearing new holes in their bodies that they didn’t use to have by placing plastic catheters in their bloodstream, their bladder, putting tubes into their lungs that can breathe for them, and we’re using very large quantities of antibiotics to treat infections. So that’s a perfect breeding ground to generate antibiotic resistant bacteria.”

Since hospital elevators lie in high-traffic areas, making elevator buttons potential sources of bacterial transmission by a wide variety of people the researchers suggest several strategies to decrease risk. These include placing hand sanitizers inside and outside elevators, installing touchless sensor buttons, or enlarging some buttons to allow for elbow activation. Education targeted at elevator users about the importance of hand hygiene could also help.

I don’t know about you but I think I might just take the stairs instead.

British Prime Minister David Cameron Warns us of the Growing Crisis of Antibiotic-Resistant Bacteria

While Canada and the United States were celebrating national holidays last week, British Prime Minister David Cameron was hard at work addressing the problem of antibiotic resistance. He announced that Britain would be taking a lead role in trying to solve what he says is a global crisis:

“We are in danger of going back to the dark ages of medicine to see infections that were treatable not be treatable and we would see many thousands of people potentially die from these infections. So it’s a very, very, serious problem and one that we have to grip, and we have to grip it globally because this is a problem that’s going to affect every country in the world.”

In concrete terms we are returning to an era when many women died after childbirth after developing a simple bacterial infection, and where a whole raft of surgical procedures would be imperiled, from hip replacements to cancer chemotherapy and organ transplants.

In an interview with London’s Guardian newspaper Cameron went on to say that, “When we’ve had these problems in the past, whether it is how we tackle HIV and Aids, how it is possible to lead the world and get rid of diseases like polio, Britain has taken a lead and I think it is right we take a lead again.”

Cameron is not going out a limb on this; rather, he is giving political voice and leadership to a growing global crisis identified as such by the world’s leading scientific bodies such as the World Health Organization who announced this year that it’s “…a problem so serious that it threatens the achievements of modern medicine. A post-antibiotic era – in which common infections and minor injuries can kill – far from being an apocalyptic fantasy, is instead a very real possibility for the 21st Century.”

So, too, the U.S. Centers for Disease Control and Prevention: “Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections;” the Public Health Agency of Canada: “More than 200,000 patients get infections every year while receiving healthcare in Canada; more than 8,000 of these patients die as a result;” and the New England Journal of Medicine: “arguably the greatest risk . . . to human health comes in the form of antibiotic-resistant bacteria.”

So Cameron is exactly right to do what he did. Now imagine the traction we could get if Prime Minister Stephen Harper and President Barack Obama would add their voices as well.

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