Para compra cialis puede ser visto como un desafío. Aumenta Smomenta, y todos los que se poco a poco abrumado, como es lógico, cada vez más hombres están diagnosticados con disfunción eréctil.
2006 IC & PBS On-Line Patient Conference Transcript
An Evening with Dr. Robert Moldwin
New, Emerging Therapies for Interstitial Cystitis
Featuring Dr. Robert Moldwin,
Associate Professor of Clinical Urology
Moderated by Jill Osborne, Presid
Date: July 11, 2006
Jill Osborne - Good evening and welcome to the 2006 IC & PBS Online Patient Conference.
Tonight is our 8th special event and we are delighted to welcome Dr. Robert Moldwin to
our event tonight. Dr. Moldwin is a name most of you should recognize. He is the author of
the IC Survival Guide, a book which has educated tens of thousands of IC patients, family
members and medical care providers on interstitial cystitis.
What you may not know, however, is that he is one of the few world experts in the
treatment of urologic infectious and inflammatory diseases and has contributed
tremendously to the treatment and understanding of these conditions. As the Director of
the IC Center at the Long Island Jewish Medical Center, he and his staff have provided
hope to thousands of patients, many of whom travel from around the world to see him.
He has published extensively in peer-reviewed journals and often serves as an advocate
and expert consultant on IC in lectures and through the media. What we appreciate most
about Dr. Moldwin is his kindness and compassion. He's one of the "good guys" who
takes the time to listen to the needs of patients and to create resources that can help.
From sponsoring IC support groups to writing the #1 best selling book on IC, Dr. Moldwin
is clearly dedicated to the cause. We are so grateful that he has agreed to appear tonight.
Welcome Dr. Moldwin!
Dr. Moldwin - It is an incredible pleasure to be with you all this evening and thank you for that
very kind introduction. Jill Osborne - Clearly, IC therapies have changed dramatically in the past ten years. What
is your current goal in working with patients?
DR. MOLDWIN – We’re always trying, of course, to find the holy grail of IC, which is to eliminate
ALL symptoms for the patient. The problems that we've learned as clinicians, and as patients
have learned, is that that is a very difficult goal to achieve. The bottom line is that there is no cure
for IC…YET! Therefore, for the time being, our main goal is to reduce symptoms as much as
possible, thereby improving the patient’s quality of life.
In this process, we try to apply one of the major medical tenets:, “Do No Harm.” As most patients
know, some of the therapies that patients have gone through cannot be the most exciting,
wonderful, or joyful experiences. Therapies can cause other problems, such as constipation,
increased pelvic pain, increased daytime fatigue and other problems that can be worse than the
original complaint. As many patients know, some of the medications that we place into the
bladder can cause a great deal of irritation, at least at the beginning. Some of the evaluations,
such as hydrodistention or placing chemicals in the bladder, can also be very uncomfortable.
Although we still have to go through some of these uncomfortable processes. Many clinicians are
now pulling away from these therapies and have adopted other therapies or diagnostic methods
that keep patients as comfortable as possible. For example, some of the earlier methods to help
diagnose IC relied upon stretching of the bladder (i.e. hydrodistention) or the placement of caustic
agents in the bladder (i.e. potassium). However, today, we have less traumatic methods of
evaluation that can be used. Jill Osborne - What I've seen in the past five years is more sensitivity towards the patient
experience and the use of testing and therapies that are more soothing and designed to
help the patient have a better experience.
Dr. Moldwin - I agree with that. We're trying to be nicer to the patient with more soothing
therapies, etc. I also see many new, young urologists coming out of training that are much more
accepting of IC, are willing to treat it and have more of an interest in the IC patient population.
They seem to be more accepting of IC issues and other coexisting conditions, whether it be pelvic
floor muscle spasms or IBS. Jill Osborne - I'm curious to see if you still see any of the older treatments for IC. What are
your thoughts on clorpactin and silver nitrate?
Dr. Moldwin - I don't use them at all. I don't like the concept of using caustic agents in the bladder.
Firstly, they may cause scarring of the bladder wall. If any of those agents have contact with the
ureter (the tube that brings urine down from the kidneys to the bladder), they can cause scarring,
which then gives that patient a whole new spectrum of problems. If they were the only agents
available, then maybe I would have to use them … but now there are other agents, more
innocuous chemicals that can be placed into the bladder, which can have as good, if not better,
When I see a patient, I need to assess where they are clinically RIGHT NOW; but I also have to
think about where that patient will be ten or twenty years from now. As we're seeing so many
more young patients in our practice, this is even more on my mind. Every time I do a
hydrodistention or a fulguration, I am always concerned about possible ramifications in the distant
future. I'm concerned about causing scarring that could limit the patients bladder capacity further.
So, I try to limit these procedures as much as possible. In the case of IC, often "less is more." Jill Osborne - What's your position on DMSO???
Dr. Moldwin - DMSO is, as you know, one of the two FDA approved medications for IC, DMSO &
Elmiron. I still use DMSO but it's not my first line agent at this time. But, I believe that although it
can be very irritating to the bladder initially, many of its features can provide benefit to the IC
patient. There is data to support its use. I generally use a “DMSO cocktail” which is comprised of
DMSO, heparin, an antibiotic, a steroid, and sodium bicarbonate. Each one of those agents has
some theoretical role in reducing symptoms.
The main problem with DMSO is that it can hurt or cause frequency, at least with the initial
instillations. Patients need to be counseled about this before they start treatment. They need to
understand that they will probably get worse before they get better. Often patients can hold
DMSO in their bladder about fifteen seconds before they need to urinate it out the first time. We
hope to see improvement in holding it and a slow improvement of their symptoms with continued
In my opinion, after
the third instillation, I expect to see some improvement in symptoms If the
improvement in symptoms is not evident by the forth instillation, we usually stop and switch to
another agent. In my experience, if you haven't improved in that time, the only thing that will occur
is the patient being frustrated, and I very much don't want to see that occur. I like to see patients
progress and improve within a reasonable period of time. There is nothing more depressing and
frustrating than sitting around for a month with an unsuccessful therapy.
The bottom line is that we pick and choose the medications on the basis of what we think will
work best but it is, in reality, a great deal of hit and miss. If one therapy is not working, we need to
move on to another therapy. Ultimately, it's the rare patient, the very rare patient, who does not
improve somewhere along the way. Jill Osborne - What therapies have you found to be the most successful or helpful??
Dr. Moldwin - Let's start with the simple stuff. Evaluation! Before we can discuss therapies, I
believe that it’s extremely important for patients to understand that most IC patients have multiple
pain generators, such as IBS (that cause abdominal or pelvic pain), fibromyalgia, pelvic floor
spasms or pelvic floor dysfunction. 70-80% of IC patients will have some degree of pelvic floor
dysfunction or spasm that may account for even more pain than the bladder pain. Of course,
vulvodynia is also frequently found. So, one of the most important parts before we get to therapy
is to try to dissect apart all of those different conditions.
I can tell you that between a good history and a good physical examination, a good clinician can
pull these specific problems apart and decide on which one merits therapy first. In my opinion, it
is unreasonable to attack everything at once because you won't know what is helping what.
Our methodology is to try to eliminate one variable at a time, and that can be frustrating, but it is,
in my opinion, the best way to begin.
Now supposing I feel that a patient has IC but the majority of their pain, pelvic pressure and even
frequency is coming from pelvic floor spasms, I will start a program of pelvic floor muscle
relaxation. This usually consists of avoiding straining with urination, aggressive control of
constipation, warm baths, local heat applications and, usually, muscle relaxants. This may be
supplemented in some instances with physical therapy.
I should also mention that there is a rapidly expanding interest in the Physical Therapy
community to get involved in this specific area … which is absolutely wonderful to see. In the past
ten years, there has been an explosion in the number of physical therapists dedicated to treating
pelvic floor dysfunction (PFD). I don’t believe that these PTs would be involved in the field if they
weren't seeing positive results. I constantly see positive results. Jill Osborne - Do you ever have patients who just don't believe that their muscles can be
contributing to their pelvic pain?
Dr. Moldwin – Absolutely, however I can usually prove it to them. We first look at symptoms.
Many patients complain of urinary hesitancy associated with pain or discomfort. They need some
time to start the urine flow. They sometimes need to push to get the urine moving along. Some
patients have constipation. Each one of these issues may be associated with pelvic floor
dysfunction. Essentially, in each of these instances, the body wants to move something out
(either urine or stool) but the muscles are just not relaxing properly; hence, these symptoms
occur. Stress can often worsen these symptoms, much like a tension headache.
Secondly, we can show patients alterations in their urination pattern using a simple test called
uroflowometry. This test displays the urine flow pattern graphically. Thjs test can be performed
along with special measurements of the pelvic floor muscle activity, a test called
electromyography. Very frequently, we see that the urine flow increases and decreases in speed
based upon inappropriate muscle activity in the pelvis.
On physical examination, we often find painful, uncomfortable trigger
points in the muscles,
themselves. With all of this information, patients usually realize that something is amiss. Finally,
patients ultimately see that therapy dedicated to pelvic floor relaxation really helps….So, I rarely
have a patient that walks out the door who isn't a “believer.” Jill Osborne - Is pelvic floor rehabilitation a short or long-term therapy??
Dr. Moldwin – I feel that pelvic floor dysfunction is akin to having a bad back. Some people get a
little back strain and it goes away and they don't need physical therapy. Other patients may be
completely debilitated and need long term, chronic therapy. So there is a wide spectrum of
severity and patient need. Jill Osborne - What therapies have you found to be successful for someone with
symptoms associated with the bladder rather than the PFD??
Dr. Moldwin - The very simplest of therapies is diet modification. We just finished a research
study this year which supports the notion that diet can cause bladder irritation and pain. Thus,
learning to avoid those trigger foods is important.
With respect to treatments, the big three that I still use a great deal of are Elmiron, tricyclic
antidepressants and hydroxyzine, I tend to use the hydroxyzine as the last agent in that group
many because the tricyclics already have some have antihistaminic properties.
There was a recent study in Germany a double blind placebo controlled study was recently
performed and published in the Journal of Urology that clearly demonstrated that amitryptiline
(Elavil) was beneficial in reducing IC symptoms. The good part is that this medication can help
patients sleep, reduce their nighttime voids, decrease their pain levels and even decrease
problems associated with allergic phenomenon.
Unfortunately, the tricyclic antidepressants have their downsides, which is why not everyone can
tolerate this medication. Patients can develop constipation, dry mouth, dry eyes, palpatations,
and weight gain. It can decrease sex drive and their ability to orgasm. If a patient already has
cardiac problems, it needs to be used with some caution perhaps under the consultation of a
cardiologist. So, it's not perfect, which is why I sometimes use Pamelor (nortriptyline), a different
tricyclic but which often has fewer side effects. Also, nortriptyline comes as a capsule which can
be opened. I’ve had some patients who couldn’t tolerate the lowest does (10 mg) able to tolerate
the medication when opening the capsule and just sprinkling a tiny bit onto their food.
Elmiron is a very reasonable medication. It’s actually the only FDA approved oral agent for IC. I
find that patients with food sensitivities seem to respond the best. I usually combine Elmiron
dosing with amitriptyline. Both medications theoretically affect two different abnormalities that are
seen in IC, namely bladder surface changes and nerve changes of the bladder wall.
The fact is that not everyone will tolerate all of these meds and it is always nice to be able to offer
patients alternatives, keeping in mind that most are not FDA approved specifically for IC.
Anti-seizure medications may improve patients' symptoms. A common medication that has been
used is the antiseizure agent, Neurontin (gabapentin). The difficulty with this medication centers
upon fatigue. Another antiseizure agent that I am personally having a great deal of success with
is Lyrica (pregabalin). I find it to be easier to dose with less associated fatigue. Another
medication that has been found useful for pain management includes the SNRI, Effexor
( . The newest SNRI that has been helpful for pain has been Cymbalta (duloxetine).
Unfortunately, Cymbalta can slow down the urine stream; therefore it should be supervised
closely. I suspect that many more medications in this class will be arriving within the next few
The audience should also understand that the prevalence of IC seems to be increasing, most
likely due to more patient and clinician awareness. Many pharmaceutical companies are
becoming interested in the development of medications for this condition. I can tell you that I've
been consulting with several companies who are developing intravesical (medications instilled
directly into the bladder) and completely new oral therapies for this condition. Jill Osborne - What are your thoughts on cyclosporine as a possible therapy for IC?
Dr. Moldwin - I think that it has potential based upon some of the known pathologies of IC. There
is some data to support the use of other immunosupressants, such as prednisone, in IC. But my
biggest concern are the complications that can arise from them. In the case of cyclosporine, the
biggest concern is kidney malfunction. So, I believe that even if it does show some efficacy one
would have to carefully weigh the risks and benefits of that therapy. Jill Osborne - AUA had yet another study on hyperbaric oxygen and IC? Your thoughts?
Dr. Moldwin - A limited study was performed in Germany and was presented at last year's
American Urological Association annual meeting. It showed that patients who received hyperbaric
oxygen had some improvement in their symptoms. They underwent 30 sessions, 90 minutes
each time and unfortunately, although there was improvement in some patients, the improvement
in those patients was typically very mild. However, the nice part was that if improvement did
occur, it usually lasted for a long duration (6-9 months).
I wonder whether subpopulations of IC patients, particularly those with Hunner’s ulcer disease (IC
with visible inflammation of the bladder wall) and patients who suffer from Raynaud’s
phenomenon (Raynaud’s phenomenon is a condition that affects the blood vessels in the
extremities—generally, the fingers and toes. It is characterized by episodic attacks, called
vasospastic attacks, in which the blood vessels in the fingers and toes constrict, usually in
response to cold temperatures and/or emotional stress.) might have a better chance of
responding favorably to this therapy. Jill Osborne - what therapies been have found to be the most successful with patients who
have Hunner’s Ulcers?
Dr. Moldwin - I find that the most successful therapy is surgical. Patients with Hunner's Ulcers
which we treat (burn) with either a laser or an electrical cautery generally do extremely well as a
group, providing that their ulcers are well defined and relatively small. The key is a deep
fulguration (burning), since the specific regions of inflammation tend to be very deep seated and
can go through the full thickness of the bladder wall.
Patients often experience many months of no pain whatsoever but, unfortunately, the ulcers
usually return proving to me that this still is a medical condition that needs to be managed with
not only a surgical approach but also with all the other facilities that we have available. For
example, most of my patients with Hunner’s Ulcers will be on medical therapy, Elmiron, Elavil,
and any other medications that might help their general discomfort.
We will often also treat these patients with intravesical therapy. The most common that we have
been using has been "anesthetic cocktails" (aka rescue instillations) which is comprised of a short
AND long term anesthetic (marcaine and lidocaine jel y) along with heparin, an antibiotic (usually
gentamycin), and a steroid (triamcinolone). Patients can instill these themselves or we can do this
in the office setting. The frequency of use depends upon the clinical situation.
If someone comes into my office with diffuse Hunner’s Ulcers, I won't take them into surgery first.
I'll use the rescue instillations to help reduce that inflammation and then possibly perform the
surgery afterwards. Obviously, if the patient is feeling well after the intravesical therapy, there’s
no reason to do the surgery. 70 to 80% of IC patients will have a greater than 50% decline in
symptoms when we instill the cocktail and over 90% of IC patients with Hunner’s Ulcers will have
a positive result.
We have used this therapy to help diagnose IC as well. Jill Osborne - Does anyone know what causes Hunner's Ulcers?
Dr. Moldwin - No, we don't know however, anecdotally I can tell you that many patients who have
them have significant allergies. I have one patient that is allergic to every tree in the north east
and that is precisely why I tend to treat these patients with higher doses of antihistamines. Jill Osborne - Can you explain the use of liposomes in IC treatment?
Dr. Moldwin - Liposomes are essentially fat molecules around a center that may be as simple as
water or more complex, like a drug. A recent study that was performed at the Univ. of PA showed
that one could calm an irritated bladder down by placing a liposome solution into that inflamed
bladder. This study was performed in rats but it does suggest that this might be a reasonable
therapy, ultimately, for human use. Jill Osborne – Your thoughts on RTX and BCG???
Dr. Moldwin - I was never a big fan of BCG because it can cause inflammation. It's one of those
therapies that may be able to help a patient now, but I don’t know if there are negative
consequences 10, 20, 30 years from now. That's why I believe in keeping therapies as simple as
possible. RTX (resinaferatoxin), which is a very hot chemical in the hot pepper family, just didn't
produce the benefit that we were all hoping for. I have a feeling that we might see better results
with some changes in the doses and timing of the doses, but I don't expect that medication to be
evaluated again in the near future. Jill Osborne - Do you have any comments about Cystistat or Uracyst, bladder coatings
used in Canada and Europe??
Dr. Moldwin - I believe that any medication that has the ability to coat or augment the bladder
surface might be beneficial. This is the concept of placing heparin in the bladder as well as
Elmiron. Cystastat theoretically works as a bladder coating agent. Studies in the US did not
demonstrate efficacy of this agent, but most clinicians who see IC patients have seen patients
respond favorably. Could it be placebo effect?… perhaps. On the other hand, I always worry that
medications that directly affect the bladder, like cystistat, may not do well in clinical trials because
much of any given patient’s pain may be coming from the pelvic floor or other sources. When the
pain doesn’t go away in an impressive way, we assume that the medication isn’t doing a good job
for the bladder when that may not be true at all. Jill Osborne - Do you see any complications with the long term use of DMSO?
Dr. Moldwin - I don't have any experience using this long term. I think it would be prudent to have
periodic blood work performed, i.e. complete blood count, liver function, electrolytes, kidney
function, etc. A concern has been raised about the development of cataracts. I recommend yearly
ophthalmologic exams, but have never seen a patient develop this problem. Jill Osborne – Do you suggest hormonal therapy or the use of birth control pills?
Dr. Moldwin - I believe that most female IC patients have some relationship of their symptoms to
their menstrual cycle. In patients that the cycle has a profound impact upon their symptoms, I
refer them to their gynecologist to consider placing them on BCPs, changing their BCPs or even
to consider BCPs that limit the number of menstrual cycles per year. Jill Osborne - Do you believe that IC is an autoimmune disease?
Dr. Moldwin - The last studies that suggested this were performed over twenty years ago when
they looked for specific bladder auto-antibodies. There was some evidence that this was
occurring but I'm not certain that this is the scenario for every IC patient. IC may be a whole host
of different diseases that have common symptom complex. That may be why not every single
patient responds to the identical therapy. I hope that, in the future, we’ll be able to distinguish one
patient group from another patient group. Jill Osborne - What do you think is the most promising line of research currently under
Dr. Moldwin - One of the most encouraging and potentially helpful findings is that of increased
levels of APF (antiproliferative factor) in the urine of most IC patients. We've been waiting for
many years for some commercial testing to be developed and we're hoping that this comes to
fruition within the next two to three years. Jill Osborne - What would you recommend for immediate pain relief for someone suffering
from an IC flare up?
Dr. Moldwin - Well, it depends upon the cause of the flare. When there is a flare and there is
burning, you still have to go back to the urology basics. This happened today. a patient was
quite upset because she thought she was having an IC flare but it turned out to be a UTI. Is it a
flare, a UTI or is it because of a terrible pelvic floor spasm due to sex or stress?
Ultimately, if it's just a bladder having a problem, I often suggest using vicodin or tramadol to
control pain. For other patients, Pyridium might be helpful. Some patients may come into the
office for an anesthetic cocktail (rescue solution) that can often stop the flare in its tracks. . Jill Osborne - Many patients struggle with quality of sleep or nighttime frequency. What
can suggest that would help them get a better nights' sleep?
Dr. Moldwin - First off, evaluation is again important. Important questions which may make a
difference in your care include: are you just a bad sleeper (well known to be a big problem in
patients who have co-existing fibromyalgia)? Do wake up because of bladder pressure or pain?
Are these large or small volumes that you void at night? Do you go right back to sleep or do you
stay up until the next void? Are you taking medications or foods that can stimulate voiding before
you sleep (diuretic/caffeine)? As you can imagine, the answers to these questions might prompt
different possible helpful therapies that could run from dietary changes to fluid intake or
medication changes to sleeping pills.
If it is related to the bladder, I think it's good to use the two birds with one stone philosophy, that
is to take care of the IC and sleeping issues using the same therapy. The typical medications
used are the tri-cyclic antidepressants and/or the antihistamines, such as hydroxyzine.
Other medications that I've mentioned previously may also have the side effect of fatigue. We can
use that fatigue to our advantage when it comes to sleeping problems by simply taking these
meds at night. Patients should understand that they can have a “hangover” effect the next
morning and that the best way to manage that specific problem is by dosage adjustment or taking
the medication earlier in the evening. Jill Osborne - Do you have a specific plan for men with IC?
Dr. Moldwin - I don't treat men with IC differently then I treat women with IC. Unfortunately, men
often go through a long misdiagnosis process, including the use of multiple antibiotics and
therapies directed towards prostatitis. Ultimately, I tend to treat each patient the same, including
workup, evaluation, etc.
One thing that I have noted in with men with IC is that if they have pelvic floor problems they can
suffer tremendously. Jill Osborne - Do you have any tips for making catheterizations more comfortable for
those with sensitive urethras?
Dr. Moldwin - Tip #1 - Like sex, you need lots of lubrication. I am extremely liberal with lubrication
and the use of an anesthetic jelly. There are some studies that show no difference in discomfort
between regular jelly and an anesthetic jelly. All I can say is that if you’re going to catheterize me,
please use the anesthetic!
Tip #2 - The most difficult part of the catheterization is where it passes through the external
sphincter. It is very easy for a doctor to say "just relax." It's not so easy to actually do that,
however, if one really focuses and does some deep breathing and a bit of meditation through that
area, it can be done with the least amount of discomfort possible. The tendency is to tighten up
when the catheter passes through that region. By doing breathing techniques, like those used
with Lamaze, the discomfort can clearly be minimized.
Tip #3 - Is the size of the catheter. I used to believe that there was no specific difference in
tolerance between sizes but, now, I fully believe that the smaller diameter catheters pass with
much less discomfort. The downside in a man is that passing a small catheter through the urethra
is that there must be some stiffness for advancement. Smaller catheters are floppier. My
suggestion, in general, is the use of a ten French catheter. Jill Osborne - Do patients really have to take Elmiron for the rest of their lives?
Dr. Moldwin - I don't think that's necessarily true. I am a very big proponent of experimentation. I
believe that if a patient is stable on a medication for a reasonable length of time, perhaps one to
two years, then it would be reasonable to decrease or discontinue the medication as a trial. In the
case of a medication such as Elavil, a relatively rapid taper and ultimate discontinuance can
occur. If symptoms were to recur they may do so anywhere from one to three weeks later. If
symptoms do return, the medication can be started again. I have never seen an instance where a
patient did not go back to their improved state.
Elmiron, as you know, can take three to six months to become effective and, therefore, when I
elect to reduce or discontinue this medication, I will usually be more hesitant. In most cases, I will
recommend that patients decrease their dose by one capsule per month. If that patient has a
worsening of symptoms with this gradual reduction, I've found it much easier to get them back to
where they were before. Of course, that’s just my anecdotal experience. Jill Osborne - Do you see IC occurring in different ethnicities??
Dr. Moldwin Yes. I think that our biggest gap when trying to understand the demographics of IC
relates to socioeconomics. Like many other illnesses, IC is underrepresented in lower
socioeconomic groups probably, in part, because they don’t have adequate access to health care
services. Jill Osborne – What are your thoughts on the use of BOTOX??
Dr. Moldwin - We have used BOTOX as a treatment for overactive bladder with injections into the
bladder wall and have had extremely encouraging results. The question is whether injections of
BOTOX into the bladder wall can improve the symptoms of patients with IC. BOTOX not only
relaxes muscle but also seems to disrupt the transmission of pain in the nerves when injected into
the base of the bladder.
However, there are still some concerns. My biggest concern is that BOTOX will decrease the
bladders ability to contract. Any patients with IC that receive BOTOX would have to understand
that there is a slight possibility that the bladder wouldn't be able to empty properly. The patient
might need to catheterize, at least temporarily, to empty the bladder completely.
Jill Osborne - Can acupuncture be helpful??
Dr. Moldwin - I've found acupuncture to be moderately helpful for IC patients. Fortunately, this is
very “operator dependent” technique and I've noted that sending ten patients to ten different
acupuncturists, they will have ten different results with different needle placements, etc. Jill Osborne - One last question on Chinese herbs. There is an acupuncturist on the West
coast who is treating IC patients with Chinese herbs, yet refuses to tell the patients what
herbs are being used? Your thoughts on this?
Dr. Moldwin - I would not use that practitioner. It makes no sense to me why anyone would ingest
any unknown agent on the advice of anyone. It's preposterous. Why would you take any
medication or food that you have no idea what the ingredients are? I would have to wager that if
their doctor gave them a pill without any information, it would be very unlikely that they would take
it. Jill Osborne - Thank you for your time tonight! Thank you so much for you time and
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