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medicine

Health data company expands in Stamford as demand grows for genetic research and personal medicine

Sema4, a health data research company, announced Thursday it opened a 70,000-square foot building in Stamford with more than 300 workers processing genomic tests, its third site in Connecticut to keep pace with growing demand for data-driven health care.

The Stamford laboratory complements Sema4 1/4 u2032s Branford lab that was expanded earlier this year and its headquarters, also in Stamford.

The new Sema4 lab replaces one in New York City, providing additional capacity to support genomic testing and expand digital health services. With its Stamford and Branford labs, Sema4 will increase its ability to provide health information across several thousand genetically identifiable diseases to patients.

Eric Schadt, founder and chief executive of Sema4, said the new Stamford site will be a hub for research and development for predictive modeling and information-driven testing.

In addition to lab employees, the Stamford facility also has capacity for 100 genetic counselors, bioinformatics specialists and support service staff. Sema4 has more than 500 employees in Connecticut across its two lab facilities and Stamford headquarters. Its workforce has quadrupled over the last three years.

Sema4 also maintains an office in New York City.

The company’s growth reflects rapid advances in personal medicine and genomics, which focuses on sequencing and analyzing an organism’s genome, the DNA content in a cell.

The state announced in 2018 a $6 million loan to Sema4 to move its New York City laboratory to Connecticut and create 400 jobs. “We were kind of busting at the seams,” Schadt said at the time.

In Connecticut, Sema4 is part of an expanding cluster of medical technology companies, such as Arvinas, a New Haven cancer pharmaceutical company, and the Guilford medical device company Butterfly Network.

Stephen Singer can be reached at [email protected]

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©2020 The Hartford Courant (Hartford, Conn.)

Visit The Hartford Courant (Hartford, Conn.) at www.courant.com

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QurAlis to Present Data on Two Precision Medicine Programs (Kv7 and TBK1) at MNDA 31st International Symposium on ALS/MND – Press Release

CAMBRIDGE, Mass.–(Business Wire)–QurAlis Corporation, a biotech company focused on developing precision medicines for amyotrophic lateral sclerosis (ALS) and other neurologic diseases, today announced that the company will present two posters featuring data from two of the company’s preclinical precision medicine ALS programs at the Motor Neuron Disease Association (MNDA) 31st International Symposium on ALS/MND, being held virtually on December 9-11, 2020.

QurAlis co-founders and Harvard professors Kevin Eggan, Ph.D. and Clifford Woolf, M.D., Ph.D., members of the QurAlis Scientific and Clinical Advisory Boards, Brian Wainger, M.D., Ph.D. (Massachusetts General Hospital) and Merit Cudkowicz, M.D., M.Sc. (Massachusetts General Hospital), and other authors recently published in JAMA Neurology the results of a clinical study investigating the therapeutic potential of Kv7 agonism in ALS. The clinical data support QurAlis’ belief that a safe Kv7 opener could be an effective disease-modifying therapy for ALS patients with motor system hyperexcitability, an approach that QurAlis is pursing with its preclinical program investigating the regulation of the Kv7.2/7.3 ion channel.

The poster presentations will share, for the first time publicly, results from preclinical studies of QurAlis’ program investigating a novel Kv7.2/7.3 ion channel agonist as a potential treatment for motor neuron hyperexcitability and excitotoxicity, as well as its program targeting the TBK1 autophagy pathway.

“While KV7 agonists have shown great potential as a treatment for the 20-50% of ALS patients who present with hyperexcitability in their motor system, they can often cause undesired side effects such as dizziness and fatigue,” said Daniel Elbaum, Ph.D., Chief Scientific Officer of QurAlis. “The preclinical data we will be presenting show that the improved channel specificity of our novel Kv7.2/7.3 agonist could translate into an improved clinical safety profile with significant reduction in off-target adverse events. We look forward to sharing the full results of this preclinical study as well as discussing our autophagy program at the MNDA 31st International Symposium on ALS/MND.”

Details of the presentations are as follows:

Title: TBK1 Autophagy Pathway Disease Mechanisms in ALS

Authors: Erika Norabuena; Clinton Bourbonais; Kasper Roet, Ph.D.; Kevin Eggan, Ph.D.; Daniel Elbaum, Ph.D.; Sandy Hinckley, Ph.D.

Presenting Author: Erika Norabuena

Date/Time: December 9, 2020, 12:10pm-12:50pm ET

Poster/Abstract Number: TST-07

Link to abstract

Title: QRA-244 a Potent, Selective KCNQ2/3 Opener and a Potential Therapy for Motor System Hyperexcitability induced Disease Progression in ALS patients

Authors: Daniel Elbaum, Ph.D.; Sandy Hinckley, Ph.D.; Kasper Roet, Ph.D.

Presenting Author: Daniel Elbaum, Ph.D.

Date/Time: December 11, 2020, 7:05am-7:50am ET

Poster/Abstract Number: TST-20

Link to abstract

About ALS

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease impacting nerve cells in the brain and spinal cord. ALS breaks down nerve cells, reducing muscle function and causing loss of muscle control. ALS can be traced to mutations in over 25 different genes and is often caused by a combination of multiple sub-forms of the condition. Its average life expectancy is three years, and there is currently no cure for the disease.

About QurAlis Corporation

QurAlis is bringing hope to the

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fitness

Life Time Fitness Files For Data Evidence On COVID Spread, Arging They’re Not Super-Spreaders

MINNEAPOLIS (WCCO) — One of the largest gyms in the country, based right here in Minnesota, argues gyms are not super spreaders.

On Friday, Life Time CEO Braham Akradi filed a request for access to government data to see the exact amount of virus spread happening in health clubs in Minnesota.

“The clubs are amongst the lowest places that they’re spreading this virus,” said Akradi.

Life Time said in a statement, “We have had approximately 3.15 million visits to its Minnesota clubs since they reopened on June 10. Since that time 352 positive cases of COVID-19 have been reported by members and/or team members. This equates to .0001% of the total amount of cases in the state.”

Life Time Fitness in Edina was the one part of Samantha Maroney’s daily routine that she didn’t cut out during this pandemic. Unlike many other activities she enjoys, she felt this was one was the safest.

“It’s really what eliminates all the worry,” said Maroney. “When you’re greeted, there’s the temperature check.”

Many other Life Time members agree. Sean Shannon says masks were required at all times in locker rooms and walking between equipment.

“Some on the equipment if they’re doing cardio, they’ll take them off, but they’re social distanced between the next piece of equipment, so nobody is right there,” said Shannon.

Maroney said her gym went beyond CDC protocols to make classes safe and getting creative. Her favorite cycle classes were held on the rooftop of the gym on sunny days.

“We were all up there on our bikes, waving our towels around, we were all socially distanced,” said Maroney.

While some want gyms to stay open this winter for the physical health. Many also crave the mental wellbeing that comes from working out.

“I come here for mind, body and soul. I come here to not only to stay in shape, but to keep my anxiety at bay and everything,” said Russell Burton, a Life Time member.

Right now, gym patrons and staff are just hoping Gov. Tim Walz doesn’t extend the closure longer than a month.

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Promising new data for Ionis’ antisense medicine targeting PCSK9 presented at American Heart Association (AHA) Scientific Sessions 2020

CARLSBAD, Calif., Nov. 13, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that new data for ION449, an investigational antisense medicine designed to reduce plasma levels of proprotein convertase subtilisin/kexin type 9, or PCSK9, were presented today at the American Heart Association (AHA) Scientific Sessions. PCSK9 is integrally involved in the regulation of LDL-cholesterol (LDL-C). Genetic studies have shown that individuals with life-long reduction of LDL-C due to reduced function of PCSK9 have substantially reduced risk of cardiovascular disease.

(PRNewsfoto/Ionis Pharmaceuticals, Inc.)

ION449, also known as AZD8233 for subcutaneous administration and AZD6615 for oral administration, is being developed as part of a collaboration between Ionis and the biopharmaceutical company AstraZeneca. ION449 incorporates Ionis’ advanced Generation 2.5 and LIgand Conjugated Antisense, or LICA, technology. In a Phase 1 study, single subcutaneous doses of ION449 demonstrated dose-dependent reductions in circulating plasma PCSK9 protein and LDL-C levels of up to >90 percent and up to ~70 percent, respectively, in humans with a baseline LDL-C between 100 and 190 mg/dL.Doses of 4, 12, 20, 30, 60, 90 and 120 mg were evaluated. The single 90 mg dose was the minimum dose required to achieve maximum reduction in PCSK9 and LDL-C. ION449 was observed to be safe and well tolerated at all dose levels.

In addition, the feasibility of oral administration of ION449 was established in three in vivo studies:

  • A study in rats demonstrated liver bioavailability of 5 percent with ION449 following intrajejunal administration, mimicking oral administration of tablets not feasible in rodents.
  • A study in dogs demonstrated liver bioavailability of 7 percent following ION449 oral tablet administration for 28 days.
  • A study in healthy monkeys found repeated oral administration of ION449 tablets for 14 days resulted in LDL-cholesterol reductions of 45–50 percent.

An oral formulation of ION449 is currently being evaluated in a Phase 1 study in healthy volunteers.

“Even with existing treatments, cardiovascular disease remains the leading cause of death worldwide, affecting tens of millions of people. Additional treatments are clearly needed for patients still at risk. The data from these studies are very encouraging and demonstrate the best-in-class potential of ION449 for lowering LDL-C via PCSK9 reduction for the treatment of patients with high cholesterol who are at risk of cardiovascular disease,” said Brett P. Monia, Ph.D., chief executive officer at Ionis.

The full poster presentations, “Single Dose Safety, Pharmacokinetics, and Pharmacodynamics of a Potent PCSK9 Synthesis Inhibitor, AZD8233, in Subjects With Elevated LDL Cholesterol” (Poster #MP515) and “An Oral Antisense Oligonucleotide for PCSK9 Inhibition in Humans” (Poster #P244) are available to view on the AHA Scientific Sessions website.

Ionis’ collaboration with AstraZeneca focuses on leveraging Ionis’ pioneering antisense technology to discover and develop antisense therapies and AstraZeneca’s expertise in drug development and commercialization. In addition to cardiovascular programs, the companies are also collaborating to discover and develop antisense drugs to treat cancer, metabolic and other diseases.

About Ionis Pharmaceuticals, Inc.
As the leader in RNA-targeted drug discovery and development, Ionis has created an

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fitness

Club Fitness Provides Notice of Data Security Incident

ST. LOUIS, Nov. 4, 2020 /PRNewswire/ — Club Fitness Holdings, Inc. (“Club Fitness”) is notifying members of the Club Fitness Community of a data security incident that may have involved certain individual’s personal information.  Club Fitness is notifying the potentially impacted individuals of this incident and providing resources to assist them in protecting their information. 

On June 18, 2020, Club Fitness discovered a data security event that prevented access to data and programs on its network. Upon learning this, Club Fitness immediately began an investigation, and took action to secure and restore access to its network.  Club Fitness also engaged cybersecurity experts to assist with its investigation and determine whether there may have been unauthorized access to any sensitive data.  As a result of the investigation, Club Fitness learned that an unknown actor gained access to and obtained data from its network without authorization.

As a result, Club Fitness conducted a thorough review of what data may have been obtained by the unknown actor, to determine whether any personal information may have been impacted.  Club Fitness determined on October 5, 2020 that certain individuals’ personal information may have been affected by this event.

Club Fitness provided written notification on November 4, 2020, to potentially impacted individuals with valid mailing addresses whose information may have been involved in the incident.  Notification letters include information about the incident and steps that potentially impacted individuals can take to monitor and protect their personal information. Club Fitness is also providing potentially individuals with steps they can take to protect their personal information, including access to complimentary identity monitoring and recovery services through IDX.

Club Fitness has established a toll-free call center to answer questions about the incident and to address related concerns.  The call center can be reached at 1-833-791-1658 Monday through Friday, 8 am8 pm Central Time.  Additional information will be available on the Club Fitness website at https://www.clubfitness.us/.

The privacy and protection of the information of its members and its community is a top priority for Club Fitness, and it regrets any inconvenience or concern that this incident may cause.

Cision View original content:https://www.prnewswire.com/news-releases/club-fitness-provides-notice-of-data-security-incident-301166797.html

SOURCE Club Fitness

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Louisiana coronavirus: 1,150 new cases, 17 more deaths reported Tuesday; see latest data | Coronavirus

The Louisiana Department of Health reported 1,150 more coronavirus cases and 17 more deaths in its noon update Tuesday.

The number of hospitalizations increased by 21, and the number of patients in need of ventilators increased by 14.

These are another few key statewide statistics as of Tuesday:

— Total cases: 184,769

— Total deaths: 5,737

— Currently hospitalized: 619

— Currently on ventilators: 84

— Presumed recovered: 168,634 as of Oct. 26 (updated weekly)

— Probable cases: 4,379 as of Oct. 28 (updated weekly)

Note: The Advocate and The Times-Picayune staff calculates daily case count increases based on the difference between today’s total and yesterday’s total of confirmed coronavirus cases. The Louisiana Department of Health releases a daily case count on Twitter based on the deletion of duplicate cases. That case count can be different than the one listed here.

You can view more graphs and charts breaking down the data by clicking here.

Louisiana began reopening for Phase 1 on May 15-16 then moved to Phase 2 on June 5. Louisiana Gov. John Bel Edwards extended Louisiana’s Phase 2 restrictions twice in August before moving the state to Phase 3 on Sept. 11.

This is a developing story. More details and analysis to come.

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health

Biogen to Present Positive Phase 2 Systemic Lupus Erythematosus Data at American College of Rheumatology 2020 Meeting

  • In Phase 2 LILAC study, BIIB059 demonstrated a statistically significant reduction in joint disease activity compared to placebo in systemic lupus erythematosus patients

  • Positive results build on previously reported cutaneous lupus erythematosus data and underscore Biogen’s commitment to the lupus community

  • Systemic lupus erythematosus is a chronic and debilitating autoimmune disease that affects multiple organ systems, with periods of illness or flares alternating with periods of remission

CAMBRIDGE, Mass., Nov. 03, 2020 (GLOBE NEWSWIRE) — Today, Biogen Inc. (Nasdaq: BIIB) announced positive data from the 24-week systemic lupus erythematosus (SLE) portion of the Phase 2 LILAC study (part A) demonstrating that BIIB059 (anti-BDCA2) was associated with a statistically significant reduction in total active joint count. The study evaluated the efficacy and safety of BIIB059, a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) expressed exclusively on plasmacytoid dendritic cells. These data, along with the previously reported findings from the cutaneous lupus erythematosus (CLE) portion of the LILAC study, will be presented at the American College of Rheumatology’s ACR Convergence 2020, being held virtually from November 5-9, 2020.

“People living with systemic lupus erythematosus suffer from chronic and debilitating symptoms that impact multiple organ systems as well as their social and emotional well-being,” said Nathalie Franchimont, M.D., Ph.D., Vice President and Head of the Multiple Sclerosis and Immunology Development Unit at Biogen. “These latest data highlight the potential of BIIB059 to impact disease activity and, together with the earlier cutaneous lupus erythematosus findings, reflect Biogen’s commitment to drive therapeutic innovation for lupus patients who have limited treatment options.”

The Phase 2 LILAC study (part A) met its primary endpoint of reducing joint disease activity in individuals with SLE, as measured by total active joint count. A statistically significant difference in change from baseline of 3.4 in total active joint count was observed at week 24 between participants who received BIIB059 450 mg administered subcutaneously every 4 weeks with an additional dose at week 2 versus placebo (p=0.037). Total active joint count is the total number of tender or swollen joints. Tender or swollen joints are one of the most common symptoms impacting quality of life in people living with SLE.

The study also met the secondary endpoint of SLE Responder Index-4 (SRI-4), resulting in an overall reduction in disease activity in participants who received BIIB059 versus placebo. There was a 26.35 percent higher SRI-4 response rate among participants who received BIIB059 (56.77 percent) versus placebo (30.42 percent [odds ratio=3.49, p=0.003]). The SRI-4 is a composite measure comprising criteria from different internationally validated indices of systemic disease activity.

An additional secondary endpoint from part A of the study in individuals with SLE evaluated the effect of BIIB059 on skin disease activity using the CLE Activity Disease Area and Severity Index-Activity (CLASI-A) score in a subgroup of participants with a baseline CLASI-A score of ≥8. There was a 20 percent higher response rate among participants who received BIIB059 (69.10 percent) versus placebo (49.10 percent) who achieved at

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fitness

Fitness tracker and smartwatch data used to predict COVID-19 cases

A preliminary study, from a large and ongoing research project, is suggesting measurements from fitness tracker wearables and smartwatches, alongside self-reported symptom data, can effectively detect cases of COVID-19. The goal of the project is to develop a real-time tracking system that can help identify and contain viral outbreaks at their earliest point.

“One of the greatest challenges in stopping COVID-19 from spreading is the ability to quickly identify, trace and isolate infected individuals,” explains Giorgio Quer, first author on the new study. “Early identification of those who are pre-symptomatic or even asymptomatic would be especially valuable, as people may potentially be even more infectious during this period. That’s the ultimate goal.”

Researchers from Scripps Research Translational Institute have previously demonstrated how influenza outbreaks can be tracked using wearable fitness devices such as a Fitbit. Early in 2020 the researchers launched a new study called DETECT (Digital Engagement and Tracking for Early Control & Treatment), which called for the general public to sign up to a research app that collects fitness tracker data and logs self-reported symptoms. By June over 30,000 subjects had signed on to the project.

A newly published study in the journal Nature Medicine is reporting the first results from DETECT, revealing fitness wearable data, along with self-reporting of symptoms, can detect cases of COVID-19 with around 80-percent accuracy. This predictive rate is significantly higher than models based on self-reported symptoms alone.

“This is really an exciting result,” says Eric Topol, Director of Scripps Research. “It shows that passive, continuous monitoring, with devices like Fitbit and the Apple Watch might turn out to be an important public health surveillance tool for COVID-19. Especially in a time when we don’t have enough tests or at enough frequency with enough turnaround of results, this might be a way to identify and isolate the individuals who are infected.”

Heart rate, sleep, and activity data were the key wearable measurements that proved most helpful in detecting COVID-19 cases. While everyone’s individual baseline measurements were slightly different, by evaluating deviations from normal measurements over time the researchers were able to effectively detect cases of COVID-19.

The predictive model being developed through the DETECT study still needs more work before it can be deployed in the real-world so Jennifer Radin, a Scripps epidemiologist leading the study, is calling for citizen scientists to download the free app and anonymously offer their wearable data to help accelerate the research project.

“We’re just getting started with DETECT,” says Radin. “We have so much more research to do and that’s going to require many more participants. I’d love for us to have 100,000 or more people. That would give us the data we need to take this to the next level.”

If you are interested in helping out with the project, more information can be found at Detect Heath Study.

The new study was published in the journal Nature Medicine.

Source: Scripps Research

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Pritzker Defends Coronavirus Data Used To Ban Indoor Dining

CHICAGO — Gov. J.B. Pritzker defended the metrics used to guide his regional COVID-19 resurgence mitigation plan, which have triggered restrictions on indoor service at restaurants and bars across most of the state.

Coronavirus positivity rates in all but one region of Illinois are above the 8 percent fail-safe threshold that leads to increased restrictions under the governor’s Restore Illinois plan and executive orders.

“Let’s be clear,” Pritzker said. “Well-meaning and reasonable people can have fair disagreements about how and where to draw lines and connect dots, but when every single metric in every single corner of our state is trending poorly, we have to take meaningful action to keep our people safe”

In addition to a positivity rate that has risen by 3.4 percentage points since Oct. 1, the number of hospitalized patients with COVID-19 rose by 73 percent, while the number of coronavirus patients in the state’s intensive care units is up by 61 percent this month, according to Illinois Department of Public Health data Pritzker shared at a briefing Thursday in Chicago.

Of the two regions where restrictions have yet to be imposed: Region 6, the Champaign EMS region, is on track to see restrictions announced Friday, having already averaged two days above the 8 percent mark. And Region 2, the Peoria EMS region, saw its positivity rate rise to 7.9 percent on the most recent day for which data was available.

The restrictions can also be triggered by a period of seven out of 10 days with both increasing positivity rates and an increasing rounded rolling average number of new daily hospitalizations of people with coronavirus symptoms. That led to the first tier of mitigations in suburban Cook County and Chicago before the regions also triggered restrictions by spending three days above the 8-percent mark.

“Bars and restaurants are spreading locations,” Pritzker said. “We need to clamp down because we need to bring the numbers down. They’re headed in the wrong direction, and unfortunately bars and restaurants are the location — no fault of the people who own them or operate them or even people who visit them — but it is true that those are places where there is a higher transmission likelihood than other locations.”

Tiered mitigations restricting indoor dining and limiting the size of gatherings have been imposed on nine of the state’s 11 regions. Region 3, the Springfield emergency medical services region, Thursday became the latest to trigger the additional measures. One region — Region 1 in Northwest Illinois — has advanced to the second tier of mitigations. “Tier 2” includes a 10-person gathering size limit and a six-person limit at outdoor tables.

Pritzker was asked whether the first two tiers of limitations that be enough to curb the spread.

“I don’t know. I really would like to know the answer to that. This virus is unknowable, seemingly,” he said. “We didn’t know when we put the stay-at-home order back in March, we didn’t know if that was enough. We

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fitness

Meet The US-Based Fitness Brand Using Data To Design The Perfect Workouts

US-based fitness brand P.volve has designed its workout programmes so they can be done anywhere. And behind all of the training is a simple idea: workouts should translate to real-life movements. Why should we go to the gym and move our bodies in a way we never do in our daily life? Despite a hugely varied repertoire of classes and streaming workouts, don’t expect to see any burpees or old-fashioned crunches. The goal is to work with your body not against it. It’s all about toning, lengthening and developing long and lean muscles. And many of the workouts are designed for busy schedules, with no shortage of high-intensity classes lasting 10, 20 or 30 minutes. But what really makes P.volve different is its well-targeted equipment range, much of which tucks neatly into a suitcase or weekend bag.

Tell me about the new LA studio and what you were looking to achieve? What about the Chicago studio?

Rachel Katzman, CEO and co-founder of P.Volve: Because we’ve built this global streaming community since day one, we have been able to connect with our members around the world and understand exactly what they want. Immediately after opening our New York studio, we knew Chicago would be the next market for us, given our streamer base there. Because of the pandemic, opening in Chicago last month in the West Loop neighborhood was all about providing a support system and wellness community for Chicago citizens, with safety, of course, at the forefront. Hosting both limited-capacity indoor classes, as well as classes on the sidewalk outside our studio really has been amazing.

In today’s world, we know that people want a hybrid approach to fitness—workout in-studio with their close friends and accountability partners, stream from home for a quick 15-minute burn when their schedule is tight, and have the option to train privately. And that’s what we strive to do at P.volve.

How has the virus changed the way P.volve runs its business and classes? Do you think these will be permanent changes? We had to follow all of the guidelines and shut down our NYC studio and production studio in March—but we knew that we couldn’t stop producing fresh content, especially given how many people were now stuck at home and facing challenges on finding ways to move.

We sent all of our trainers tripods and lighting equipment, so they could easily produce videos from their homes. We produced content for our 0n-demand platform but then also released free content on our Instagram channel daily, so that anyone had access to ways to workout from home—even if they weren’t already a member with us. We also quickly launched a seven-day reset program, which included nutritional tips.

We’ve always been a data-obsessed company, but now more than ever, we are really listening and watching what specific content people want. We spend countless hours a week watching our members and our trial participants,

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