My Writings. My Thoughts.

WHAT DRUGS CAN AND CANNOT BE USED SAFELY WITH VIAGRA?

Some drugs classified as vasodilators, commonly used to treat symptoms of heart disease such as the chest pain of angina pectoris, tend to lower blood pressure. Medications like nitroglycerin and isosorbide are classified as nitrates. Because these medications, as well as some others known as alpha blockers like prazosin (Hytrin), lower blood pressure the same way that Viagra lowers blood pressure, the combined use of the two types of medications is discouraged. If blood pressure drops too much, as it may when the nitrates and Viagra are taken together, there is insufficient blood flow to the brain and in that case, a man will black out and faint. It is possible that other unfavorable drug interactions will be discovered in the future, but for the moment, it is the combined use of Viagra and nitrates that is most worrisome. This may create a hardship for millions of men with heart disease who have relied on nitrates to ward off or control the cardiac pain of angina pectoris.

PRESCRIPTIONS WITHOUT PROPER DIAGNOSIS

Men eager to get their hands on and doctors willing to prescribe Viagra may do so without pursuing the standard diagnostic evaluation accorded to all men with erectile dysfunction.

What has emerged is a worrisome phenomenon of prescribing without diagnosing. This has resulted in a sequence of events in which a man suffering from impotence or erectile dysfunction builds up the courage to discuss this with his doctor. The harried doctor hears the term “erectile dysfunction” and without either exam or diagnostic evaluation scribbles a prescription for Viagra and hustles the man out of his office. This all-too-common practice has allowed men with serious conditions such as pituitary tumors to go undiagnosed. This is an unfortunate consequence for men with prolactinsecreting pituitary tumors, where delay in diagnosis allows further pituitary tumor growth and poor prognosis.

The man with erectile dysfunction deserves something more than a prescription. Asking about standard medical history, conducting a physical exam, reviewing possible risk factors, and taking hormone measurements as outlined elsewhere in this book are essential procedures. Once the physician is confident there are no other sexual impediments such as depression, cigarette smoking, diabetes mellitus, low testosterone, or high prolactin levels and no cardiac history, then a prescription for Viagra is in order.

TAKING THE WORRY OUT OF SEX

There is a natural tendency to fret whenever new medications make it easier for men and women to have trouble-free sexual intercourse. Certainly when birth control pills became available, women who had previously shied away from intimate relations could feel more comfortable and less frightened about becoming pregnant. The birth control pills were introduced just before the 1960s sexual revolution and no doubt played a role in contributing to the sexual freedom and perhaps the promiscuity of that era. Women who took their birth control pills daily could and did engage in sexual intercourse more often than they had before the availability of this medication. However, other powerful forces were afoot shaping this turbulent decade, and the birth control pill is probably best viewed as a “facilitator” rather than an instigator of a more relaxed attitude toward sexual behavior. Not all medical advances that made it easier to have sex have had a comparable impact on sexual mores.

When penile prosthesis surgery was introduced a decade earlier, some worried that when impotent men were suddenly equipped with a device that allowed them to have an “on-demand” erection, their sexual behavior would change. They would no longer confine their sexual activities to the privacy of their bedroom but would be inclined to stray and seek out new and varied sexual partners. Some may have, but all of the currently available data indicate that the majority of impotent men who had penile prosthesis surgery were pleased to be able to have sexual intercourse again with their spouses alone.

WHY WAIT ONE HOUR AFTER TAKING VIAGRA BEFORE HAVING SEX?

Once the Viagra tablet is swallowed, the medication passes through the stomach and into the bloodstream. It takes about forty minutes to one hour before sufficient Viagra has built up in the body to be effective, but a man’s penis does not automatically become erect and stiffen at this time. Viagra works only in a setting of sexual stimulation such as the standard embraces and genital stimulation and caressing that is a normal component of healthy lovemaking. In this way, Viagra more closely mimics the normal pattern of sexual interaction between couples than does penile injection therapy, penile prosthesis, or MUSE.

PHILANDERING AFTER VIAGRA: FANTASY, FEARS, AND REALITY

The potentially dangerous interaction of Viagra with medications commonly used to treat heart conditions was anticipated, whereas the sudden empowerment of once impotent men with a new sense of sexual security was seen as a benefit, not as a threat. No one envisioned that anyone could interpret the availability of this new medication otherwise. Somebody did. What happened?

DOES VIAGRA WORK FOR EVERY IMPOTENT MAN?

While Viagra improves sexual function for men whose impotence is caused by a wide variety of physical and emotional problems, it does not work as well for every man every time. Much has been made of the fact that following his prostate cancer surgery, former senator Bob Dole participated in one of the early Viagra trials. He was so pleased with the result that he went on the Larry King Live show touting the benefits of this new medication for men with erectile dysfunction. Not all men who have had prostate cancer surgery do as well as former senator Dole. After prostate cancer surgery, less than 50 percent of Viagra-treated men are able to have sexual intercourse. This is especially true in men who have had the more aggressive prostate cancer surgery called radical retropubic prostatectomy (RRP), which cuts into neurovascular bundles vital for normal erectile function. Other coexistent medical problems such as diabetes mellitus and spinal-cord injury may also limit Viagra’s efficacy.

HOW WILL SILDENAFIL (VIAGRA) BE USED?

Once men with preexisting heart problems and those using nitrate medications are excluded, there remain millions of impotent men for whom Viagra treatment is both useful and appropriate. Those men should know how to use Viagra to achieve maximum benefit.

The usual starting dose of Viagra is 50 mg, taken one hour before planned sexual activity.
Men over age sixty-five are advised to start with a 25-mg dose, again one hour before planned sexual activity.
Men who have no adverse effects from taking one dose of Viagra but do not achieve an ideal erectile response at that dose may take the next-higher dose, up to a total single dose of 100 mg.

Men who have side effects such as light-headedness, dizziness, or headache at any dose are encouraged to “step down” and try a lower dose to minimize or eliminate these adverse effects. Some men who are able to tolerate the 50-mg dose but feel they have not had a fully satisfactory dose may do better on the higher 100-mg dose of sildenafil.

WHAT CAUSES DEATH IN MEN WHO TAKE VIAGRA?

In November, 1998, just six months after Viagra was approved, 6 million prescriptions had been written for this medication and 50 million Viagra tablets had been dispensed. In this interval, 130 men died sometime after they took Viagra. We know this because of what is called post-marketing surveillance.

Once a medication has been approved for use and is available by prescription, doctors continue to look for an unexpectedly high number of their patients developing one problem or another.

The close relationship that most doctors have with their patients allows for a frank discussion of treatment results and adverse effects of any new medication. Most patients do not hesitate to tell their doctors when a medication has caused a particular problem. Doctors all over the country then gather this information and report back to the drug company — in this case Pfizer — or the FDA, which is obliged to survey and keep accurate records of problems that were not apparent before but surface only after a new drug is released. The official term for this data collection is “post-marketing surveillance.”

As a result of post-marketing surveillance, we know that abnormal liver function tests may occur with some common cholesterol-lowering medications. Thus, doctors prescribing these medications periodically do special blood tests to see if their patients have had any disruption in their liverfunction tests, and if so, they stop the medication so that that liver function returns to normal.

Hours Elapsed Between Sex and Fatal Symptom, Usually Chest Pain*
Chest Pain Number of men
During sex 27
4-5 hours 44
More than 5 hours 6
More than 24 hours 8
More than 48 hours 5
3-7 days later 4

* Most (70%) of the men who died had one or more risk factors for heart disease including high blood pressure, elevated cholesterol levels, cigarette smoking, diabetes mellitus, obesity or a known cardiac history. Some even had vials of nitroglycerin tablets in their pockets at the time of death. Only tweleve men had no cardiac history, but for them the interval between the use of Viagra and the onset of their symptoms was so prolonged that it seemed unlikely that Viagra actually contributed to their deaths. Nonetheless, they are included in the survey. For Viagra, post-marketing surveillance provided valuable information on the number of men who died after using this medication and also provided more information on those men for whom Viagra was risky. Details leading up to the deaths were varied. For example, one man was murdered and another drowned. Three expired after suffering strokes, and 77 had heart problems. Forty-one of those 77 had definite or suspected heart attacks, and 27 men died because their heart stopped beating (cardiac arrest).Excluding the 2 men who were murdered or drowned, we know that 44 (34 percent) of the 128 men who died had the onset of heart symptoms, usually chest pain, four to five hours after they took Viagra. Twenty-seven had their symptoms during or immediately after sexual intercourse. Six experienced heart pain much later on that same day. In others, the association between Viagra use and onset of symptoms was more tenuous, with 8 noticing chest pain more than twenty-four hours later, 5 fortyeight hours later, and 4 three to seven days after Viagra use.As a result of these findings as well as other post-marketing surveillance problems such as painful prolonged erection (priapism), a new set of warnings regarding safe use of Viagra was issued. Men should not take Viagra if they have:

  1. Very high (> 170/110 mmHg) or very low ( <90/50 mmHg) blood pressure.
  2. Severe heart disease and chest pain from angina pectoris.
  3. Had a heart attack, stroke, or irregular heartbeat (arrhythmia)   within the last six months.
  4. Retinitis pigmentosa.
  5. A prior history of painful prolonged erections.
  6. Liver failure.
  7. Severe kidney disease.

WHO WILL AND WILL NOT HAVE HEART STRAIN DURING SEX?

Men who have decreased cardiac blood flow during sexual intercourse are the same men who have decreased heart blood flow with any sort of exercise. When doctors want to know exactly how much exercise a man can tolerate, they do an exercise stress test and ask the man to walk on a treadmill. While he is walking, his heart rate and blood flow can be measured. During the exercise stress test, the man is encouraged to do as much as possible to establish his “cardiac reserve” to define how much activity his heart can tolerate.As a man walks faster and faster on a treadmill, his heart rate (the number of beats per minute) increases. Men with the least damage to their hearts can reach peak heart rates of about 150 without showing evidence of heart strain. During sexual intercourse, their peak heart rate reaches 117 and shows no signs of heart strain. Contrast this to men with cardiac problems who develop chest pain during sexual intercourse. The peak heart rate they can muster is 113 during exercise. But when the strain of sexual intercourse pushes their heart rate beyond this limit to 122, their hearts cry out in pain. Men with less severe heart disease can achieve higher heart rates and may have no discomfort during sexual intercourse, yet their cardiograms still show evidence of heart strain.

  • Heart attacks develop when the heart does not receive enough oxygen due to low coronary artery blood flow. Viagra lowers blood pressure, and when combined with other medications like nitrates, which also lower blood pressure, it can diminish coronary blood flow, setting the stage for a heart attack.
  • Two other unexpected problems, unrelated to nitrate use, may occur. One affects men with a predilection for another type of heart problem called an arrhythmia, or irregular heartbeat, which means not just any skipped heartbeat but a dangerously irregular heartbeat called ventricular tachycardia. Men who develop this irregular and chaotic heart rhythm usually have major heart damage as a result of prior attacks. It appears that when such men use Viagra to enable them to have sexual intercourse, they may also increase their chances of developing ventricular tachycardia.

Ventricular tachycardia is a life-threatening irregularity of the heartbeat. Often, men who develop ventricular tachycardias require cardiac shock therapy to jolt their hearts back to a normal heartbeat. It may be that men with such severe heart disease with a known predisposition for ventricular arrhythmias should also be discouraged from using Viagra.

  • The other unanticipated problem affects female sex partners of men who use Viagra. Bladder infections called cystitis develop in about 15 percent of women who have had sexual intercourse with Viagratreated men. It has been known for some time that there are some women who often develop bladder infections after sexual intercourse. The term “postcoital cystitis” has been used for those women who develop bladder infections after sexual intercourse. In severe cases, antibiotics are necessary to treat the bladder infection. On most occasions, all that is required to prevent postcoital cystitis is adequate hydration and urinating immediately after sexual intercourse.

DEATH AFTER SEX AND/OR VIAGRA

Along with its obvious pleasures, sexual intercourse poses a definite risk to a man’s health. We have known for some time that the heart works harder to keep pace with the excitement and passion of sexual intercourse. Under normal circumstances, when healthy men have sexual intercourse their heart rate and blood pressure increase. When men with heart disease have sexual intercourse, their damaged hearts cannot always keep pace. Often, men with heart problems can neither muster the pulse increase nor blood pressure elevation their bodies expect. The act of sexual intercourse demands a physiologic response that is sometimes beyond what the damaged heart can supply.

In the pre-Viagra era, for example, men questioned after they had heart attacks (myocardial infarctions) recalled that chest pain was the first clue to their impending heart attack. They can often relate the onset of their chest pain to some physical or emotional stress. Sometimes that stress is physical, like the exertion required to lift a heavy object or shovel snow. Sometimes the physical exertion is the act of sexual intercourse.

· Men who die immediately after having had sexual intercourse (also known as coitus) are said to have experienced a “coital death.” Heart attacks are what kill most men. Occasionally, doctors are curious enough to inquire into the events preceding a man’s fatal heart attack and want to know if he was:

1. Sleeping quietly in bed and never woke up the following morning.
2. Rushing to catch a train when he had chest pain and then collapsed on the rail station platform.
3. Embroiled in a fractious argument with a business colleague or competitor or with a rebellious child, wife, or lover.
4. Lifting weights or shoveling snow.
5. Having sex sometime during the twenty-four hours before he expired. If so, then he would be classified as having had a coital death.

In 1963, thirty-five years before Viagra, we knew that among men who die suddenly very few (0.6 percent) have coital deaths. Some men have their fatal heart attack during or immediately after sexual intercourse. Subsequently, other reports told us that:

Twelve percent of men admitted to the hospital with nonfatal heart attacks will admit that they have had sexual intercourse two to twenty-four hours prior to the onset of their chest pain.
The heart’s response to sexual intercourse has actually been studied in some detail. In the interest of science, some men with known heart disease have agreed to have their pulse, blood pressure, and heart strain measured during sexual intercourse. After being hooked up to wires that record their heart rate and change in cardiogram pattern, they have sex in the privacy of their own bedrooms. The next day, their records are analyzed. The men also keep a log of any cardiac symptoms (chest pain, palpitations, and so on) they might have experienced during sex.

These reports told us that almost one-third (31 percent) of men had cardiogram patterns suggesting heart strain (called coronary ischemia). Only 7 percent had chest pain during sex. The majority (24 percent) of those with heart strain during sex had no discomfort and were classified as having “silent coronary ischemia.”

FEAR OF VIAGRA

“I didn’t use the pills,” confessed Walter, a cherubic sixty-five-year-old pipe smoking academic, when I asked him how the Viagra samples I had given him had worked out.

“My wife wouldn’t let me,” he said in explanation.

“But it was your wife who was most concerned about your impotence.” ( Walter and his wife had not had sex for three years.)

“In fact, she was the one who called to set up your appointment. What happened?” I wanted to know.

“She decided that living with sexual frustration was better than living as a widow.” Walter heaved a regretful sigh, then went on. “It’s in the papers, you know, and on TV, and on radio, about all those men who drop dead right after they used Viagra.”

At this time, late November 1998, just months after this new medication had come on the market, newspaper reports indicated that 130 men died sometime after taking Viagra. Almost all were known to have severe heart problems. Many were taking nitrate medications like nitroglycerin and isosorbide (Isordil) and should not have used Viagra in the first place. I was aware of that, but I also knew that the majority of men who used Viagra successfully experienced no, or only trivial, side effects. Thus, millions of impotent men had had their sexual potency restored with Viagra. The small number of unfortunate men who expired sometime after they used Viagra paled in comparison to the overwhelming majority of men who had used Viagra, achieved erections, had satisfactory sexual intercourse, and had experienced no ill effects.

“More than 6 million men have used Viagra safely and with only positive results,” I explained to Walter. “Those few men who died all had serious cardiac disease. Many were taking medications that were not safe to use with Viagra. Walter, you do not take any of those medications and you have never had any heart problems. For men like you, Viagra can be both safe and effective.”

I double-checked his record yet again to ensure that he had none of the coexistent medical problems and was not taking any of the inappropriate medications that were part of the profile of the unfortunate men who had expired after taking Viagra. Walter simply could not be reassured.

“If you are not comfortable with Viagra, would you be willing to try . . .?” I listed other treatments to help correct his impotence, but his wife’s concerns had so rattled him that he had lost interest in his own sexuality. If he were forced to choose, as he believed he was, between living and dying, he would of course choose living. By rejecting all treatments to retrieve his ability to enjoy sexual intercourse again, Walter made a definitive decision. He opted for what he anticipated would be a long, albeit celibate, life.

“I guess you could say that having life without sex is better than no life at all” was how he put it, before he shook my hand. “Thank you so much for trying to help.”

Then this once ebullient, now dejected, professor dropped his chin to his chest and left so quietly I barely heard the door close behind him.

Evan was next.

A short, balding, beefy-faced retired engineer, Evan was both the father of two grown daughters and a proud grandfather. He had been plagued by years of sexual failures and was as sexually insecure as Walter. Unlike Wal

ter, Evan had actually used the Viagra samples and couldn’t wait to tell me how well they had worked.

“Twice in one night, Doc, I’m telling you, twice in one night! One right after the other! Mary was stunned. She called me her stud. I’m telling you I haven’t been that virile since I was in my twenties.” He beamed.

Glistening perspiration gathering on the dome of his scalp migrated toward his eyes, circumvented the detour created by his plump eyebrows, then coalesced into parallel streams to trickle like cascading sideburns down his face. As a salacious grin split his seventy-four-year-old ruddy and wrinkled face, he leaned across the desk. Like a teenager energized after his first sexual experience, he continued excitedly, determined to elaborate about his further adventures with Viagra.

“Listen to this, listen to this,” he said, barely able to contain himself.

” Mary and I went to the monthly condo meeting the next night, and everyone was talking about Viagra, mainly what they read or the latest Jay Leno Viagra joke. I didn’t say anything at first, but then Myra, this redheaded widow from 12C, started sounding off. She thought it was terrible that there was so much interest in this sex drug and not enough attention paid to more important medical problems like prostate cancer, which had taken her Morrie from her when he was only fifty-nine.”

“Well, that was the night after Mary and I had our double-header, you know what I mean, Doc. I wanted to say something but held my tongue for a while, but then Myra she just kept going on and on, yammering about how the medical profession is interested only in men’s sexual problems but is not paying enough attention to other health issues, and she just wouldn’t shut up, so I finally said, ‘It certainly could help some men who need it.’ ”

“How would you know?” she challenged.

“Well, you know, just what I read about.”

“Have you ever tried Viagra?” Myra was dogged and persistent.

“Yes,” I admitted, “I guess you could say that I am the Man from Viagra.”

“Really?” she pulled her chair closer. “How does it work?”

“Very well, I would say.”

“How well?” Myra wanted to know. “She was determined to get details, and I was wondering how I would avoid telling her any more, when . . . ‘Myra, how nice to see you,’ Mary boomed. ‘I couldn’t help noticing you’ve been having such a nice long chat with my husband. Whatever did the two of you find to talk about for so long?’ ”

A week later, Evan called to say that his wife Mary thought they would both be better off if he stopped taking Viagra.

What transpired after the condo meeting was that Evan, the self-proclaimed Man from Viagra, and his wife Mary were now, thanks to the talkative Myra, unwilling condominium celebrities. Neighbors who barely spoke to them all year were now seeking them out. Mary was invited to a series of

coffees, and Evan, who had always been something of a loner, was now in demand as a companion. Suddenly, extra sports-event tickets materialized for Evan, and Mary was suddenly in demand as a bridge partner. At the time, Viagra was so new that both the men and women wanted more information from “experts.” But their curiosity was gender-specific.The men were more interested in process and mechanics — How long did it take to kick in? Was it really guaranteed to work? Did Evan wake up with a headache . . . or indigestion . . . or see blue?The women were more interested in feelings and wanted to know what it was like for Mary after all these years. She told them that she was surprised at the sudden rekindling of Evan’s interest in her as a sex partner. They had of course been faithful to one another for years, and even without sex, each had been totally committed to and dependent on the other. Mary was actually quite pleased at how things had turned out. Then, the others, women who were widowed like Myra, told Mary over and over again how fortunate she was and wondered whether Evan, who was, after all, so handy, could come over and fix a faucet, help with their taxes, or just drop by. All of this sudden attention and the news reports started Mary wondering.

1. Can Viagra cause otherwise healthy men to keel over and drop dead after sex?
2. Will impotent men who become potent after taking Viagra turn into senior citizen Lotharios and, as Mary feared, menace the condominium subculture and disrupt the fabric of every elderly couple’s otherwise tranquil life? See “Philandering After Viagra: Fantasy, Fears, and Reality” below.

Concerns about Viagra’s safety surface at both the doctor’s and the patient’s level.

1. Doctors are concerned that the patient for whom Viagra is prescribed be an appropriate candidate for this medication. Always cautious, doctors avoid giving a Viagra prescription if there is a high probability of a medication-induced side effect. They have been advised not to prescribe Viagra to any man with severe heart disease, particularly if he is taking medications like nitroglycerin or isosorbide (Isordil). Others for whom the use of Viagra would be unwise include those men with very high or very low blood pressure or those with an inherited eye disorder called retinitis pigmentosa.2. Men with sexual problems are understandably troubled by reports of sudden death occurring in men shortly after they take Viagra.

The disquiet of physicians and their patients is ultimately translated into the number of men who actually walk out of the doctor’s office with a Viagra prescription. One of my colleagues, Dr. Andre Guay, who is director of the Sexual Dysfunction Program at the Lahey Clinic in Peabody, Massachusetts, has kept a running tabulation of the numbers of men he has seen in consultation in the first six months after Viagra was approved by the FDA.

Number of Men with Complaints of Erectile Dysfunction for Whom Viagra Was and Was Not Appropriate
Evaluated 551 patients
Medically unsuitable 44 (8.6%)
Fear of Viagra 65 (12.8%)
Lost to follow-up 13 (2.6%)
Total not using Viagra 122 (24%)
Using Viagra 429 (76%)
SOURCE: Andre Guay, M.D., F.A.C.E.

Even when doctors try to identify only those men who are appropriate candidates for Viagra and weed out others for whom Viagra might pose a substantial health risk, a third group surfaces. They are the men who are so frightened by the press reports of death after Viagra that they refuse Viagra treatment on their own. Indeed, at the Lahey Clinic more men opted out of Viagra treatment on their own than were disqualified because of any known risk to their health.

Why would impotent men reject a treatment that might allow them to have sex once again? Which is more perilous, sexual intercourse or Viagra?

Viagra danger: IF YOU TAKE NITRATES, YOU MUST NOT TAKE VIAGRA!

Viagra danger

Pfizer was quite adamant about this from the beginning.

Not only did they tell doctors about the Viagra danger of mixing nitrates with Viagra, but they alerted pharmacists to this drug interaction. So, when patients went to fill their prescription, most pharmacists checked their computers to see if the man for whom Viagra was prescribed had in the past also filled prescriptions for nitrates. If so, pharmacists were supposed to indicate to these men that the two prescriptions were incompatible. Pharmacists could then warn a man of the dangers of taking Viagra if he was also taking nitrates.

As if that were not enough, the package insert accompanying the bottle of Viagra tablets also informed men of the hazards of taking Viagra if they were also using nitrates.

Even those entrepreneurs who were hawking Viagra over the Internet were careful to make sure that their on-line clientele had answered “no” to the question “Are you taking nitrates such as nitroglycerin, isosorbide, or Isordil?” Only then would they ask for the customer’s credit card number and address to send both the Viagra tablets and a bill. (The cost for on-line Viagra is about $10.00 per pill, plus shipping and handling, and for the online “consultation” about $85.00 — caveat cyber emptor!)

Warnings from the doctor’s office, at the pharmacy, and even on-line were not sufficient. Men who should not have taken Viagra still did, and unfortunately some of them died.

Why?

Just before Viagra was released, I had the opportunity to speak before a group of Pfizer representatives and indicated that no matter how many warnings they put in place, men being men would always want to “stretch the sexual envelope” in the hopes of recapturing their lost sexual brio.

I had anticipated the following scenario:

An impotent man with known heart disease, taking nitroglycerin or isosorbide or both, is nonetheless eager to have sex. So one day he does not take Isordil. That evening he takes Viagra, gets an erection, has sex, and sometime during the middle of, or after completing, the sex act he develops heart pain (angina pectoris). Automatically, he reaches into his pocket for a nitroglycerin tablet, puts the tablet under his tongue, has a sudden fall in blood pressure and collapses.

This sequence of events or something similar seems to have been responsible for many of the deaths attributable to Viagra. It was primarily those Viagra-treated men with severe preexisting heart conditions or those taking inappropriate medications who succumbed after sexual intercourse. But was it the Viagra or the sexual intercourse that was responsible for their demise?

Before this question could be answered, the newspapers and television news stations were filled with reports of men who used Viagra, had sex, and then died. This created a new problem: fear of Viagra.

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