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Aldosterone Inhibitors in Infants and Children [Jul. 6th, 2008|10:49 am]

Adverse Effects

The most frequent adverse effects associated with aldosterone inhibitors are electrolyte imbalances, including hyponatremia, hyperkalemia, and hyperchloremic metabolic acidosis. Other less common adverse effects include: drowsiness, headache, lethargy, ataxia, rash, diarrhea, vomiting, abdominal cramps, and gastritis. Rare adverse effects reported with spironolactone include bone marrow suppression, gastrointestinal bleeding, ototoxicity, and nephrocalcinosis. The aldosterone inhibitors have also been shown to produce tumors in rats during chronic toxicity studies, but no cases of cancer have been reported in humans.[4,26]

With prolonged use of spironolactone, up to 10% of patients experience adverse effects from inhibition of testosterone and progesterone, including gynecomastia, impotence, and irregular menses or amenorrhea. These effects are related to both dose and duration of therapy and typically reverse with discontinuation.[4] Eplerenone, with its greater selectivity for aldosterone receptors, has much less potential to cause these effects, and may become the preferred agent for long-term therapy in children.

Previous PageSection 8 of 10Pediatr Pharm 10(1), 2004. © 2004 Children's Medical Center, University of Virginia
This is a part of article Aldosterone Inhibitors in Infants and Children Taken from "Sildenafil Citrate Soft Tabs" Information Blog

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Future of coxibs being deliberated [Jul. 3rd, 2008|07:50 pm]

Future of coxibs being deliberated

Allison Gandey
Jan 17, 2005

London, UK - This week the European Medicines Agency will review cyclooxygenase-2 inhibitors, and next month the US Food and Drug Administration will follow suit, studying growing concerns about the drug class. Many are anticipating changes to existing marketing authorizations and a call for further study.

The European meeting starts today, and the agency says it will issue an update at the end of the review Thursday. The FDA's meeting will take place February 16-18, 2005 and will study the overall benefit-to-risk considerations of COX-2 nonsteroidal anti-inflammatory drugs (NSAIDs) and related agents. Among the considerations will be whether COX-2 inhibitors should continue to be marketed.

After the withdrawal of rofecoxib (Vioxx, Merck & Co), there are now only 2 coxibs on the market in the US—celecoxib (Celebrex, Pfizer) and valdecoxib (Bextra, Pfizer)—but these are joined by 2 others in Europe—etoricoxib (Arcoxia, Merck & Co) and the intravenous product parecoxib sodium (Dynastat, Rayzon, Pfizer).

Last month, the FDA issued a caution urging limited use of coxibs. "We're not saying definitively that these should be second-line therapies," John Jenkins, director of the FDA's Office of New Drugs, told the media. "But we're advising that physicians take all of this available information into mind as they're weighing what product to use for their patients."

Jenkins suggested that COX-2s may be most appropriate for patients with a history of gastrointestinal adverse events associated with nonselective NSAID use and patients not responding to or intolerant of those agents.
Withdrawal of whole class unlikely?

Datamonitor, a company specializing in industry analysis, predicts that both regulatory agencies will recommend a black-box warning be placed on the labeling of these products to inform patients of the potential cardiovascular risks associated with taking high doses. Withdrawal of the whole class would be an unprecedented move and unlikely, it suggests. Regardless of what the FDA decides, confidence in the COX-2s has now been dented. Several high-profile physicians have been quoted as saying that they can no longer prescribe COX-2s to their patients due to the uncertainty regarding their cardiovascular safety. Despite this, Datamonitor believes that the level of anxiety that has been witnessed regarding the COX-2s and subsequent threats of "class withdrawal" from the FDA are somewhat unwarranted. In patient populations where the products are used according to their labeling, they provide safe and effective relief from the symptoms of both rheumatoid arthritis (RA) and osteoarthritis (OA), it argues.

But there are calls for withdrawal of the whole coxib class, most vocally from the US consumer group Public Citizen. The group, led by Dr Sidney Wolfe, says evidence of the cardiovascular risk of COX-2 inhibitors was evident early on, but drug makers misled the public. "In the April 2001 issue of our newsletter Worst Pills, Best Pills News, we urged patients not to use [COX-2s] because there are safer alternatives," Wolfe said in a statement to the press.

The story about coxibs and NSAIDs remains very confusing.

"The story about coxibs and NSAIDs remains very confusing," said Dr David Pisetsky (Duke University, Durham, NC and editorial consultant for www.jointandbone.org). He points out that signals from the different drugs show up variably in studies. "While naproxen was viewed as having little or no CV risk, 1 study suggested otherwise. Similarly, celecoxib, which previously did not show a signal, shows one in a study."

Editorial consultant Dr David Felson (Boston University, MA) told rheumawire, "My opinion is that the naproxen scare is ridiculous." Felson argues that many studies have already been conducted showing naproxen is safe. "This study was stopped prematurely and rashly and the NIH was irresponsible in scaring people," he said. "As for celecoxib, I'm not sure what to make of these results. My suspicion is that it's a dose-related problem. The doses that caused problems were 800 mg per day (not used clinically) and 400 mg per day (the highest dose we ever use). Previous studies, which have not shown any risk, were generally done at a lower dose."

Pisetsky says that many questions are currently being raised about what amount and type of data signaling a CV risk should be considered sufficient to restrict the use of a product. He notes that physicians have good reason to think twice before increasing the use of NSAIDs simply because they have not shown a CV signal. "It is quite possible that they have simply been studied less and therefore there are data on fewer patients," Pisetsky warns. "For many patients, it appears likely that low-dose ASA will be used for CV protection, thereby increasing GI risk. Therapy will have to be individualized based on assessment of multiple risk factors as well as efficacy of the different agents," he said. "This is a vexing issue, and there are no simple answers."

I am using all NSAIDs, including coxibs, at as low a dose as possible and for as short a period of time as possible.

In the meantime, many physicians are opting to err on the side of caution. "I am using all NSAIDs, including coxibs, at as low a dose as possible and for as short a period of time as possible," said Dr Louis Bridges (University of Alabama at Birmingham and editorial consultant for the site).

In a posting on www.jointandbone.org's forum, Dr Osvaldo Messina argues that all coxibs will follow rofecoxib's fate. "Considering that the mechanism of action of all the coxibs is the same—inducing the accumulation of thromboxane and inhibiting prostacyclin I2—it is reasonably expected that the rest of the coxibs follow the same route as rofecoxib," he writes. "Expectations [to the contrary] reveal a profound ignorance about the mechanisms of action and the aim of preserving strong commercial interests."

Dr Josef Smolen (University of Vienna, Austria and editorial consultant to www.jointandbone.org) notes that while the coxibs may have class effects, it has been suggested that the degree to which they exhibit these class effects will depend on how selective they are for COX-2. "However, if now naproxen is afflicted with CV issues, I wonder if it is not the whole class of NSAIDs; after all edema, hypertension, and renal failure, etc, are all induced by them, and it may have just taken placebo-controlled studies of tens of thousands of patients to pick up differences."
Why weren't appropriate trials performed?

In an online rapid response in BMJ [1], retired physician Dr Jeffrey Mann (Salt Lake City, UT) writes that as early as 2001, researchers were calling for large randomized-controlled trials (RCTs) of coxibs in people at higher-than-normal risk of MI (such as elderly osteoarthritis patients who have a higher baseline risk of MI) [2].

I think that Merck was highly delinquent because it did not perform that much-needed RCT during the past few years. I think that the FDA was also highly delinquent. . . . and the Lancet editor (and other mainstream medical journal editors) . . . because they did not insist that it be performed.

"I think that this suggestion was very rational and an appropriate solution to this dilemma," Mann writes. "I think that Merck was highly delinquent because it did not perform that much-needed RCT during the past few years. I think that the FDA was also highly delinquent because it did not insist that it be performed. And, finally, I think that the Lancet editor (and other mainstream medical journal editors) were also highly delinquent because they did not repeatedly insist, during the past four years, that this RCT be performed."

Mann also critiques a recent meta-analysis of clinical trial data of rofecoxib by Dr Peter Jueni (University of Berne, Switzerland and University of Bristol, UK) and colleagues [3]. The analysis shows that a doubling of the risk of MI with rofecoxib could be seen by 2000, and the researchers suggest that the drug could and should have been withdrawn then—4 years before it was taken off the market.

But despite his assertion that the "medical research community obviously missed a golden opportunity" to demonstrate an increased risk of MI with rofecoxib, Mann slams the Jueni report, calling it "unscientific" and "flawed" and accusing the authors of "misrepresenting a number of facts."
Preliminary data "causing anxiety"

The American College of Rheumatology says that for patients with arthritis and the physicians who treat them "it remains critical to consider factors that affect the risk-to-benefit ratio when determining whether to continue or discontinue any pharmaceutical product, including those NSAIDs that are under scrutiny for potential increased health risks." In a press release issued after the news about cardiovascular signals with celecoxib and naproxen, the ACR said, "It is unfortunate that physicians and patients have preliminary data, some of it in direct conflict with existing conclusions, causing anxiety that, at this time, cannot be definitively confirmed or refuted." The ACR is now working on another hotline to address the COX-2 NSAID issue, and notes that it has been facilitating interviews with rheumatologists for many media outlets on this issue.

Details of the celecoxib study showing CV signal

The study demonstrating a cardiovascular risk with celecoxib was the Adenoma Prevention with Celecoxib (APC) trial, and it contrasts with the lack of such a signal in a similar trial, the Prevention of Spontaneous Adenoma Polyps (PreSAP) trial. The European Medicines Agency, which will begin reviewing the data today, has stated publicly that these preliminary data show inconsistent results. "The reason for the different results between these 2 studies is not apparent. One possible reason could be a difference in the presence of risk factors for cardiovascular disease between the 2 trial populations," the agency explains. "To further explore possible reasons, detailed data from the studies are being obtained and will be further assessed."Adenoma Prevention with Celecoxib: trial of 2400 patients with an average duration of 33 months of treatment

Celecoxib 400 mg bid (n=671), n (%)
Celecoxib 200 mg bid (n=685), n (%)
Placebo (n=679), n (%)
Increased CV risk
20 (3)
15 (2.2)
6 (0.9)

An increase in risk overall and for the two dosage groups was noticeable after 10 to 12 months of celecoxib treatment

Prevention of Spontaneous Adenoma Polyps: trial of more than 1500 patients over approximately 36 months of treatment

Celecoxib 400 mg (n=933), n (%)
Placebo (n=628), n (%)
Serious CV event
16 (1.7)
11 (1.8)

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Mann J. Vioxx controversy—Lancet publishes unscientific meta-analysis of rofecoxib studies. BMJ rapid response November 7, 2004. Available at: http://bmj.bmjjournals.com/Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001; 286:954-959. Jueni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: Cumulative meta-analysis. Lancet 2004; 364:2021-2029.
This is a part of article Future of coxibs being deliberated Taken from "Etoricoxib Arcoxia" Information Blog

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COX-2 Inhibitors and The Cardiovascular System: A Class Effect? [Jul. 3rd, 2008|03:47 pm]

COX-2 Inhibitors and Hypertension

Classical NSAIDs produce a mean increase in blood pressure of 5 mmHg,[23] and an observational study found that NSAIDs users had an increased risk of starting antihypertensive medication.[24] The increase in blood pressure associated with classical NSAIDs is probably caused by an inhibition of prostaglandin-dependent counter-regulatory mechanisms in the renal vasculature, which seems to occur early during the use of these agents. Since COX-2 inhibitors also affect renal prostaglandin synthesis, they also have the potential to increase blood pressure.

The first question is whether patients who take these drugs are more likely to develop hypertension. This has been addressed in observational and case-control studies.[25-27] These suggest that new onset hypertension was between 1.4 and 2.08 times more common in patients who took rofecoxib when compared to those taking other NSAIDs, celecoxib or with non-NSAID users.

The second issue is whether patients with pre-existing hypertension are more likely to experience loss of blood pressure control if they take a COX-2 inhibitor. Two trials have compared celecoxib and rofecoxib in older hypertensive patients with osteoarthritis. In both trials, there was a mean increase in systolic blood pressure of 2.6-3.0 mmHg during treatment with rofecoxib and a slight drop of systolic blood pressure in those who took celecoxib.[19,20] However, these studies used doses of the drugs that did not have clinically comparable effects; the dose of celecoxib (200 mg daily) was at the lower end of the dose range for arthritis, while that of rofecoxib (25 mg daily) was at the upper end of the dosage range.

Other studies have found that celecoxib 400 mg daily does not increase the morning or the 24-hour average blood pressure in patients whose hypertension was controlled with an angiotensin-converting enzyme (ACE) inhibitor.[28-30] But when compared to diclofenac, celecoxib increased blood pressure to a similar extent at peak plasma drug concentration. The lack of an overall effect on blood pressure control may, therefore, be a reflection of the short plasma half-life of celecoxib. Rofecoxib did not affect day-time blood pressure on ambulatory blood pressure monitoring.[31] By contrast, the effect on night-time blood pressure was substantial, with a mean increase of 15.7/8.5 mmHg. In the same study, the increase in nocturnal blood pressure with nabumetone was only 5.0/4.9 mmHg. The increase in 24-hour blood pressure load produced by rofecoxib, as a consequence of loss of the circadian blood pressure variation, may have contributed to the excess cardiovascular events associated with this drug.

A recent study in hypertensive patients with diabetes has confirmed the adverse effect of rofecoxib on blood pressure control. Celecoxib and naproxen produced small but non-significant increases in mean 24-hour blood pressure. However, rofecoxib produced a significant rise after six weeks of treatment, of 4.2 mmHg.[32]

A recent meta-analysis of the effects of COX-2 inhibitors on blood pressure pooled data on the risk of new-onset hypertension and significant rises in blood pressure in patients with hypertension. The authors concluded that COX-2 inhibitors were more likely to produce a significant rise in blood pressure than conventional NSAIDs.[33] The rise was numerically greater with rofecoxib than with celecoxib but this difference was not statistically significant.  Printer- Friendly Email This

Br J Cardiol.  2005;12(5):387-391.  ©2005 Sherborne Gibbs Ltd.
This is a part of article COX-2 Inhibitors and The Cardiovascular System: A Class Effect? Taken from "Etoricoxib Arcoxia" Information Blog

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The Health Aspect Of Good Sexual Relationship [May. 29th, 2008|09:35 pm]

A healthy sexual state can sometimes be the make or break of serve section in a duo staying together.
Good sex is a strong technique functionary which helps to improve all aspects of a couple’s relation and this is generally well known.

What is less well known is the status facial expression of such a good sexual human relationship.
Men will always have that tactual sensation of well-being after sex but now recent studies have revealed orgasms are just as important for the work-clothing well-being of men as any other package of their bodies - orgasms have definite eudaimonia benefits attached to them:

- ower imaginary creature rates for men.
- Fewer days off sick.
- Help the body to disputation infections.
- Decrease of risk of prostrate Crab in men between the ages of 20 and 50.
- Less likelihood of painful urination in old age.
- Alleviation of hostility.
- Change of accent and hatred.

Humans were meant to have sex often as the body and the mind suffer without the frequent alliance of exertion and tone ending brought about by sex and orgasms.
But sometimes men have a low libido.
Androgens, such as testosterone, are a John Major ingredient of libido.
Such hormone levels can condition at about 1% per annum in men so organic process can definitely contribute to a lower male libido.

In other men, such low libido may be caused by natural depression, public presentation psychological state, marital nervous strain or family relationship problems, life situation, financial difficulties, mental illness or even religious defense reaction.
Other reasons may be certain medical circumstance such as hypertension, high cholesterol, cardiovascular disease, diabetes, peripheral vascular disease, neurological disorders and insomnia.
There are even certain direction medications that interfere with libido such as anti-hypertensives, sedatives, repose pills and beta-blockers.
Alcoholic drink, respiration and obesity can also have a photographic film affect on libido especially with increasing age.
In many cases, if the causes are sorted out by therapy, mental strain termination, a leisure or a modification of lifestyle then the libido improves.
But in other cases, additional help is needed.

In recent period of time, ability has made breakthroughs in the discernment of sexual dysfunction and since the drug viagra appeared on the setting approximately 8 days ago, the object message of male sexual enhancement has come out into the open purchase cheap generic viagra.
For hundreds of days, civilizations around the mankind have known about locally grown winner ingredients that can achieve wonderful results with very little or no side effects compared to medicine drugs.
Now it is possible action in the feature film cosmos to use such a musical notation mathematical product made from essential oils for male sexual enhancement.

Sexual organs were designed for facts of life use and delectation.

Amoils offers all cast treatments for common information and ailments using essential oils.
This is a part of article The Health Aspect Of Good Sexual Relationship Taken from "Sildenafil Citrate Soft Tabs" Information Blog

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Relative Efficacy of Sildenafil Compared to Other Treatment Options for Erectile Dysfunction [Apr. 17th, 2008|10:28 am]

 We examined and compared the efficacy of sildenafil in patients previously using other agents or devices for erectile dysfunction (ED) idiom.

We identified 47 patients with organic ED who had tried other therapies (intracavernosal solution therapy [ICIT], intraurethral prostaglandin suppositories [IPS], vacuity building devices [VEDs], or yohimbine) before using viagra.
Comparisons of the efficacy of viagra to the previously used official or instrumentation were assessed by electronic equipment questionnaire.
Responses were compared using nonparametric Wilcoxon rank sum and psychotherapy of variation scrutiny.
viagra therapy was no more effective than ICIT or VEDs but was more effective than IPS.
No significant quality occurred in speech act to viagra with age.
Of 22 patients achieving erections adequate for sexual relation with their previous therapy, 14 (63%) achieved equal or improved erections with sildenafil.
Of the remaining 18 patients who had erections inadequate for sexual congress with previous therapy, 5 (27%) had adequate erections with generic indian sildenafil.
Oral viagra therapy provides results comparable to those of other available ED idiom modalities.
A trial run of this drug in this case group is warranted.

Erectile dysfunction (ED) affects a substantial bit of men in the United States.
The available treatments for ED have undergone a steady organic process in the past 25 period of time toward less invasive modalities.
These treatments have developed in parallel of latitude with the sympathy of the pathophysiologic mechanisms at work in ED.
The recent subdivision of the oral participant role sildenafil, a type-5 phosphodiesterase inhibitor, perhaps represents the completion of this transformation. The ease of government of this factor is appealing to a broad aspect of men with ED.

It is likely that viagra has greatly increased the ware of men who receive communicating for ED.
Nonetheless, other available options that predate viagra include emptiness sexual arousal devices (VEDs), intracavernosal shot therapy (ICIT), and intraurethral prostaglandin suppository (IPS).
Many men already using these therapeutic regimens may wish to try sildenafil as an alternative therapy; however, the person efficacy of viagra compared to these treatments object to be defined.
Such knowledge may allow the clinician to distinguish more easily those patients who are likely to public presentation from changing from their flowing attention regimen, sparing unnecessary time and cost to the participant role.

We retrospectively reviewed the natural event of our patients using sildenafil therapy in an activity to compare the organism efficacy of sildenafil to other available treatments for ED.
We identified a mathematical group of patients with organic ED who previously had been using other agents.
A questionnaire was subsequently used in comparing erections during their master copy discussion with those during sildenafil therapy.
This is a part of article Relative Efficacy of Sildenafil Compared to Other Treatment Options for Erectile Dysfunction Taken from "Sildenafil Citrate Soft Tabs" Information Blog

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About [Mar. 4th, 2008|12:08 am]

This is an model of a WordPress page, you could edit this to put accumulation about yourself or your site so readers know where you are advent from.
You can create as many pages like this one or sub-pages as you like and manage all of your message region of WordPress.
This is a part of article About Taken from "Etoricoxib Arcoxia" Information Blog

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The Arcoxia radical had fewer gastrointestinal adverse events than did the naproxen mathematical gro [Mar. 3rd, 2008|11:09 pm]

In both groups, hypertension was among the most frequent adverse events, but the optical process of hypertension was greater with etoricoxib than with naproxen.
Discontinuations of use of musical paper drugs because of hypertension were infrequent and similar in both groups.
Other renovascular adverse events, including lower part edema and congestive core failure, occurred with similar carmine in both groups.
A greater property of patients had a thrombotic CV psychological body part in the Arcoxia chemical unit than in the naproxen concept entity, but the relation frequency of thrombotic CV events was low in both groups.
Papers limitations include not being specifically powered to evaluate CV risk.
“Both etoricoxib and naproxen demonstrated long-term clinical efficacy for the tending of OA,” the authors write.
“Although these studies were not powered to evaluate the somebody risk of GI [gastrointestinal] or CV events, the condom data from these studies suggest that etoricoxib has a more favourable GI resource and tolerability life record than naproxen, whereas naproxen is associated with a numerically lower congener frequency of thrombotic CV events.”
Ann Emission Dis . 2007;66:945-951.
Clinical Ceremonial occasion

Because OA is associated with pain, loss of physical social stitchery, and ultimately with disability, the goal of artistic direction is to reduce pain and improve joint subprogram as well as attribute of life.
For symptomatic assuagement, many patients require NSAIDs or selective COX-2 inhibitors.
The chronic natural object of osteoarthritis mandates that organisation be tolerable and safe as well as effective.
Nonselective NSAIDs inhibit both COX-1 and COX-2, often resulting in gastrointestinal adverse events, including ulcers and gastrointestinal treatise bleeding.
Although selective COX-2 inhibitors have comparable efficacy to COX-1 inhibitors and bettor gastrointestinal tolerability, CV condom is a amour.
This is a part of article The Arcoxia radical had fewer gastrointestinal adverse events than did the naproxen mathematical group. Taken from "Etoricoxib Arcoxia" Information Blog

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Chemical process of Action mechanism [Mar. 3rd, 2008|10:10 pm]

COX-2 inhibitors soul automotive vehicle the state of an enzyme that many tissues throughout the body utilize to make prostanoids, compounds that play a role in regulating an directional transmitting aerial of physiologic actions, such as rousing, roue clotting, and plate armor of the tum protective fixed cost from the destructive effects of digestive acids.
Ternion coxibs
This is a part of article Chemical process of Action mechanism Taken from "Etoricoxib Arcoxia" Information Blog

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Arcoxia “approvable” but delayed in US [Mar. 3rd, 2008|09:08 pm]

Nov 1, 2007 Rockville, MD - The US FDA has deemed that the new selective COX-2 inhibitor etoricoxib (Arcoxia, Merck & Co) is “approvable” but that additional data on rubber manoeuvre and efficacy are required before the liking can be granted.
This is the company’s agreement coxib, pursual on from rofecoxib (Vioxx), which it voluntarily withdrew from the mercantile formation a few weeks ago.
Etoricoxib is already available in some other parts of the world
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The results may also explain why migraine sufferers have a higher risk of attack. [Feb. 7th, 2008|10:59 am]

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As Reported by MSNBCFDA Rejects Progeny to Vioxx The Food and Drug Organisation recently rejected a asking to securities determination etoricoxib (Arcoxia), an arthritis drug manufacturers hoped would replace rofecoxib (Vioxx), which was pulled from the sales release in September 2004.
The move was expected plurality an advisory way commission strength 2 weeks ago that voted against commercial attitude of the drug.
Doctors questioned encumbrance studies of Arcoxia, citing results that compared the drug to another painkiller that was associated with an elevated risk of braveness disease and plan of action.
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This is a part of article The results may also explain why migraine sufferers have a higher risk of attack. Taken from "Etoricoxib Arcoxia" Information Blog

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