PREMiSe study results

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Re: PREMiSe study results

Postby Shayk » Sun Mar 17, 2013 12:00 pm

While I think the Buffalo results as far as we know them at this point are a serious blow and very discouraging, I think we all probably want to know more.

I was interested in knowing more about the so-called “disease activity” that suggested angioplasty “may” make people worse and wondered if the “disease activity” they mentioned "may harm" people with MS was specifically related to data about lesions. From a CTV article, it sounds like the Buffalo info is dependent at least in part on what they found re: brain lesion activity.

Liberation Treatment Offers No Sustained Improvement for MS—Study
“MRI scans showed some patients had increased brain lesions, one of the hallmarks of the progressive neurological disease, after undergoing the vein-opening procedure, said neurosurgeon Dr. Adnan Siddiqui, co-principal investigator of the pilot study.”

Does anybody know if the study also included measurements on brain atrophy or iron deposition?

I seriously question (and always have) whether or not “lesion counts” are all that important, so I would really like to see the data on other MRI measures such as atrophy and iron deposition. I hope Buffalo included that in their analyses and will also release that data.

Are lesion counts all that significant?

Here are some snippets from a MS Discovery Forum article on MRIs:
More than Meets the Eye: the promises and pitfalls of MRI imaging in multiple sclerosis (emphasis added):
”A fundamental complication, however, is that MRI pictures and movies raise more questions than they answer.

Intuition tells us that lesions, or plaques, can’t be good for the brain, but their meaning for a person’s functional status and future is unclear.

The stumbling block is the so-called clinicoradiological paradox: Abnormal spots on MRI often don’t manifest in physical or cognitive symptoms.

As the movies from Boston illustrate, brain scans can be red herrings, pinpointing neural-tissue changes that don’t match up with how a patient feels. And physicians cannot always trace symptoms to a particular spot on a scan.”

Really, the neuros rely on intuition? LOL....
“Of all its uses in the MS field, MRI’s current ability to predict short- or long-term clinical outcomes is most controversial (Goodin, 2006).”

“Complicating the picture further, the plaque is not necessarily all bad news: Within it, some remyelination can be occurring.”

MRI for monitoring and treating MS: A work in progress
But beyond diagnosis, MRI’s utility is less certain: Its helpfulness has not been clearly established for tracking disease course and treatment responses.”

“Moreover, “simple correlations [between MRI measures and clinical outcomes] are not what you want,” says George Ebers, a neurologist who studies MS epidemiology and genetics at Oxford University in the U.K.

To justify the time and expense of costly MRI scans, he says,

the important question is whether imaging contributes value “independently of everything else” in predicting disability, particularly in the long run. The answer is “no” for changes in T2 lesion volume and Gd-enhanced lesions, say Ebers and Martin Daumer, director of the nonprofit Sylvia Lawry Centre for Multiple Sclerosis Research in Munich.”


“In a nutshell, MRI as it is used is not a good investment” for predicting outcomes, Daumer says. (Nor does it have value for monitoring patients, he says, as it adds little information beyond symptoms or relapses.)”


“The arguments and counterarguments about predicting outcomes with MRI can be downright dizzying.”
LOL—they can about CCSVI too…..

“Working with Ebers and others, Goodin determined in a multivariate analysis (at a group level) that T2-lesion and brain atrophy changes during the original 3-year trial did not independently correlate with the accumulation of severe physical disability at 16 years (Goodin et al., 2011). “


“Goodin acknowledges that his analysis represents only one data set, includes only two time points, and needs to be replicated.

Yet, the broader point, he says, is that the MS imaging community has “a technique that they’ve really never properly validated” as a proxy for long-term disability—the ultimate outcome that MS patients, doctors, and investigators care about.”


They're going to use "invalidated" techniques to dismiss CCSVI when all they can do is criticize Dr. Zamboni for his techniques? Really now....what's up with that? :roll:

Sorry this turned out to be so long….I just think info about CCSVI needs to be pursued and I for one do not want to be fooled about what “lesions” tell us, or, more accurately, what they don’t tell us. Apparently most neuros are totally enamored with lesion counts—too bad. Their true colors are shining through.

Back to my question, does anyone know if Buffalo also measured brain atrophy or iron deposition in their study?

Take care all….onward.

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Re: RIP: Rest in PREMiSe

Postby Cece » Sun Mar 17, 2013 12:09 pm

Squeakycat wrote:The key point you bring out here strongly suggests, as you say, that treatment was not successful in improving blood flow.
That has to be the starting point.
First, we need someone to show that angioplasty done correctly can improve the blood flow in CCSVI veins.
Then, we need improvement of blood flow to be a requirement for a trial to be able to make any conclusions.

RIP: Rest in PREMiSe
lol! I see what you did there.
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Re: PREMiSe study results

Postby MomJ » Sun Mar 17, 2013 12:11 pm

Have they found that people who dont have valves, dont respond as well or that it doesnt last if no valves?
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Re: PREMiSe study results

Postby Cece » Sun Mar 17, 2013 12:16 pm

Shayk wrote:Back to my question, does anyone know if Buffalo also measured brain atrophy or iron deposition in their study?
The UB researchers found no difference in clinical symptoms, brain lesions as determined on MRIs or quality of life outcomes between MS patients who underwent balloon angioplasty to correct CCSVI and those who did not receive the treatment.

Clinical symptoms, MRI brain lesions, and QOL questionnaires.
No mention of brain atrophy or iron deposition measurements.
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Re: PREMiSe study results

Postby Cece » Sun Mar 17, 2013 12:34 pm

MomJ wrote:Have they found that people who dont have valves, dont respond as well or that it doesnt last if no valves?

It's been estimated that at least 80% of the time, the problem is the valves themselves. Instead of moving, the valves are fixed in place and block the flow. That was my problem.

The other 20% of the time, the problem might be a hypoplastic too-small vein, or a septum or membrane, or a recanalized clot, or outside compression from a bone or muscle, or other possibilities. One of the reasons we advocate for the use of IVUS during CCSVI treatment is because IVUS takes images from within the vein so the doctor gets a very good look at what the exact problem is.
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Re: PREMiSe study results

Postby Cece » Sun Mar 17, 2013 12:47 pm

"Our finding only suggests that using a balloon to open up observed venous narrowings in our cohort of patients, which was very carefully selected, did not show any benefit and demonstrated possible harm when looking at MRI activity."

Perhaps using balloon angioplasty isn't the right treatment option, Siddiqui suggested.

"I'm convinced that this particular intervention does not work for this particular disease finding," he said.

"So what we'd like to do is take a step back and really understand the disease further, so we could come up with a much more directed hypothesis as to what kind of intervention will actually work for these patients."

Read more: http://www.ctvnews.ca/health/liberation ... z2NpMsaCKs

Ohhhhhhhhhh.
He is concluding that balloon angioplasty is ineffective at treating CCSVI.
When he says disease, he means CCSVI, not MS. Take a step back and understand CCSVI better to find what kind of intervention will work for CCSVI.
This is not the right direction. Dr. Sclafani persisted with balloon angioplasty despite early failures, because the alternatives such as stenting are worse, and because it is possible to find the just-right sweet spot of high-pressure correctly-sized-through-IVUS balloons.
We need a randomized trial of Dr. Sclafani's techniques before we give up on balloon angioplasty for CCSVI.
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Re: PREMiSe study results

Postby Shayk » Sun Mar 17, 2013 2:13 pm

No mention of brain atrophy or iron deposition measurements.

Thanks Cece.

I find it difficult to believe that Buffalo didn't measure either one or both of those since they are well published in brain atrophy and iron deposition. Maybe that info will be forthcoming at the poster presentation, scheduled for Wednesday, which I've found on the AAN site is entitled:

P04.273– “Percutaneous Transluminal Venous Angioplasty (PTVA) is Ineffective in Correcting Chronic Cerebrospinal Venous Insufficiency (CCSVI) and May Increase Multiple Sclerosis (MS) Disease Activity in the Short Term: Safety and Efficacy Results of the 6–Month, Double–Blinded, Sham–Controlled, Prospective, Randomized Endovascular Therapy in MS (PREMiSe) trial” – Robert Zivadinov, Buffalo, NY

Interesting that this info only reflects results at 6 months.

Onward...

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Re: PREMiSe study results

Postby MrSuccess » Sun Mar 17, 2013 3:37 pm

I'll start by saying how pleased I am at the careful and measured comments directed towards the PREMISE study , and it's research team.

One of the FIRST things you learn about MS and brain lesions is that the Neurology world sees a connection. They like to count ... :roll:

However. [ the National MS Society webpage is/was my source ] It is also proven that upon - autopsy - people who lived their complete lives WITHOUT ever having been diagnosed as having MS ....... were discovered to have had multiple BRAIN LESIONS.

In fact ...... brain lesion counts in normally healthy people ..... are well known to the Neurological World. In fact .... your Neurologist probably has some .... and your MRI tech.

And the cab driver that drove you to the Clinic. Just ask a honest Neuro .... or do some research on your own. :idea:

As I have stated above ^^^^^^^ ..... the Neurolgy World ... will NOT accept the PREMISE study for the reasons I have said. They CANNOT cherry pick the information from the study , that supports their view . It's ALL or nothing . And they will choose ... nothing.

In 2008 , Professor Zamboni discovered CCSVI and suggested there might be a connection between his great discovery and MS. His critics responded by saying that no such condition exists. The PREMISE study states CCSVI [ blocked veins] exists. To reject the PREMISE documented proof ....... they must reject the WHOLE study. They will, for now.

As more and more brilliant medical professionals began to explore Professor Zamboni's new discovery. The Neurology World ..... shifted tactics .... now claiming that the CCSVI procedure was dangerous . Red flag's everywhere. Safety became a huge issue. Dr.Zamboni himself expressed grave concerns , if his discovery was performed outside of carefully controlled clinical settings. I share his and the Neurologists view on this.

Now , the PREMISE study say's that the procedure is SAFE. This is a big deal . That large and looming worry , has been tested and is labeled as SAFE.

To accept the PREMISE study .... is to ACCEPT that the CCSVI treatment procedure is SAFE. If you reject that CCSVI is safe .... you must reject the whole study. Again .... no cherry picking dear Neurological World. It's .... YES it is ..... or ..... NO it is not.

So what's left . Does the procedure pay off ? Does it work ?

Time will tell.

I look forward to reading more details of the PREMISE study. Getting CCSVI published in one of the respected Neurological Journals and/or presented at their conferences ... has long been a goal of pwMS that have CCSVI. The opposition has been fierce . Over their dead body. They mock and scoff.

It now appears another CCSVI goal has been achieved. :!: :lol:

Great bit of information about lessions and MRI's , Sharon.

Like all tools , in the wrong hands , the MRI .... can be harmful. :!:

I accept ALL of the PREMISE results. Dr.Zivadov ? I love this guy. If he wasn't a superb medical professional ..... he'd make a great General .


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Re: PREMiSe study results

Postby ThisIsMA » Sun Mar 17, 2013 7:31 pm

Were these procedures conducted by a neurosurgeon instead of an interventional radiologist??? If so, that seems very strange to me. In the press release I didn't see any mention of interventional radiologists. If I'm mistaken please correct me.

Also, maybe its my cog fog, but it seems that these two quotes are mutually exclusive:

The UB researchers found no difference in clinical symptoms, brain lesions as determined on MRIs or quality of life outcomes between MS patients who underwent balloon angioplasty to correct CCSVI and those who did not receive the treatment.
and
MRI scans showed some patients had increased brain lesions, one of the hallmarks of the progressive neurological disease, after undergoing the vein-opening procedure, said neurosurgeon Dr. Adnan Siddiqui, co-principal investigator of the pilot study.”

How can there be "no difference" in one quote, and "increased brain lesions" in the other quote? Also the word "some" is very vague, it could mean one or two patients showed increased brain lesions. But clearly no matter how many of the treated group showed increased brain lesions, it wasn't any more than the untreated group! So how can this be turned into a statement saying that the treatment may make patients get worse? Its "normal" for people with MS to get worse over time, so the fact that some of the treated group had new lesion activity, but no more so than the placebo group, is not an indicator that the procedure made the treated patients get worse. Its just an indicator that MS makes people get worse.

Also there is this quote from their press release:

The study’s key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients.


O.K. the fact that they used the word "sustained" makes me suspect that the at least some if not many or most of the treated patients may have had temporary improvements. This is another hint that they may have been under-treated and then re-stenosed.

My thoughts are that:

A) We need to see more details, including before and after images of the stenosed viens. Did they undertreat? Is so, this was a waste of money and patients time. The fact that blood flow did not improve any more in the treated group than the sham group is a very ominous clue.

B) We need to quit wasting money on donating to trials that are not run by interventional radiologists with extensive experience treating CCSVI using IVUS.

And what I really mean by that is that I suspect that at least those of us in the USA and Canada should be putting all of our donations and efforts into helping fund a trial where the procedures are done by Dr. Sclafani himself. Dr. S's credentials and intentions are impeccable. We all trust him.

How can we make this happen? Has anyone set up a nonprofit yet to accept donations specifically for this goal? Could the CCSVI Alliance spearhead this effort? It would be fine with me if they need to take a little admin cut of each donation (5%?) to help them run their organization. Would Dr. Sclafani agree to conduct the study? Dr. S. is not getting any younger (and neither are we)! We need to make this happen before he decides to retire and the establishment succeeds in sweeping the whole thing under the rug. Or is the Annette Funichelo foundation the right place to give? Given how drug focused the medical establishment is, it could be another 100 years before anyone takes a look at this again, if we let it die now.

Its really scary to think that a potentially very beneficial treatment could be abandoned due to some combination of lack of experience on the part of well intentioned researchers, and in some other cases, willful attempts to derail what may be a valid theory on the part of people wed to ineffective but profitable drug treatments.

On the other hand, if CCSVI turns out to actually not be effective, we have to accept that. But I don't think we're anywhere near that point yet (and I hope we never will be)!
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Re: PREMiSe study results

Postby cheerleader » Sun Mar 17, 2013 7:49 pm

Here is the presentation made by BNAC at the ISNVD conference in February-- on venoplasty for CCSVI:

Cine cerebrospinal fluid imaging changes in patients with multiple sclerosis after venous angioplasty. A 1-year follow-up study
Conclusions: This study shows that in MS patients with CCSVI, PTA treatment has a beneficial effect on CSF flow and velocity measures. This improvement could be due to better venous drainage following angioplasty.

page 38
http://isnvd2013.euromedicpoland.com/us ... tracts.pdf

No mention was made of the upcoming Premise study announcement at the ISNVD. Nothing. The other researchers only heard about the benefit of PTA on CSF flow, and how the use of IVUS helped.
And then the next month, the AAN poster (no abstract/published paper) and a very professional looking video announcement claiming there is no benefit to PTA in a 6 month study.
What's the truth? Is there a beneficial effect, or isn't there? Or does it matter who is hosting the conference?
profoundly frustrating,
cheer
PS...Jeff's still enjoying his placebo effect. Now 4 years. Healthy gray matter, no MS progression.
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: PREMiSe study results

Postby ThisIsMA » Sun Mar 17, 2013 8:41 pm

Cheer said:
and a very professional looking video announcement claiming there is no benefit to PTA in a 6 month study.

Yes I noticed the quality of that video and meant to comment on it! It was kind of weirdly professional. It seemed as though he was reading from a script, and that there may have been more than one camera? Because partway through the first speaker's very clearly and slowly read, apparently scripted statement, the camera angle changed. Who paid for that video and why was it so much more professional looking than previous ones???

O.K. now I have to laugh at myself: am I turning into a conspiracy theorist? But seriously, I did notice the video quality, I did wonder who funded it, and why it was deemed important enough to warrant such a polished professional scripted treatment.

And why put out a press release on a study that does not yet even have an abstract published, so no way for reporters to impartially fact check...?

And why not publish both studies (that reach opposite conclusions) to both audiences? That would surely provide a much more balanced and realistic picture of the current state of CCSVI research.

Who benefits from cherry picking which audiences see which study?
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Re: PREMiSe study results

Postby MrSuccess » Sun Mar 17, 2013 11:00 pm

Are you not reading the information I have given ?

With few exceptions , all eyes on TIMS , want CCSVI to become an effective mainstream low cost treatment for MS. As with DMD's .... results will vary. PREMISE proves that.

The next CCSVI step forward is PUBLICATION in a respected Neurology medical journal. The next step forward is having CCSVI presented in a respected Neurology Seminar.

Much has been overcome. The sceptical medical professionals doubted that CCSVI even existed. PREMISE proves that it is real. It was a small CLINCAL TRIAL. It - CCSVI - exists.

Opponents of CCSVI moved onto new ground. Is it Safe ? The small CLINICAL TRIAL called PREMISE ...... proved that YES , it is SAFE , to undergo the procedure. S - A - F - E .

Although brief , I thought the comments from the people involved in PREMISE , to be very encouraging. What did they say ? This is the BEGINNING ....... not the end. Read it please.

The MOST IMPORTANT message taken from the PREMISE study is that pwMS should STOP running to slipshod fly-by-night CCSVI while-you-wait ..... smooth operators. DO NOT sell your house , borrow money , whatever ...... and give it to these charlatans. :evil: :evil:

Having ANY well known CCSVI doctor act as the Lead investigator in any future Trial ... won't fly with those still opposing the concept of ms being treated via CCSVI.

I accept the PREMISE Trial results . I doubt the Neurologists will. They will take the position that the numbers are too small. If the Neurologists ACCEPT the PREMISE TRIAL results ...... that means that :
[ A ] they agree CCSVI .... EXISTS
[ B ] they agree CCSVI is SAFE.

Sorry , no cherry picking here boys and girls ..... you either accept or reject the entire study and it's published findings.

Let's not question the professionalism of the PREMISE study. I think they did CCSVI well.


Watson ! The Games afoot !

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Re: PREMiSe study results

Postby ThisIsMA » Mon Mar 18, 2013 10:03 am

Hi Mr. Success,

Yes I have been reading what you are writing in this thread, I just do not entirely agree with it! :-D

Perhaps I am just a pessimist to your optimist, and I do grant all of us the right to our opinions, including you and me.

The information we have about the PREMISe study so far, in one place says PTA is safe, in another says PTA may make people's MS worse (that doesn't sound like they're saying its safe to me)! And it seems contradictory to me...

Also I would not characterize all the doctors doing CCSVI procedures outside of clinical trials as (and these are your words):
"slipshod fly-by-night CCSVI while-you-wait ..... smooth operators."
. Some may be. And many are not using the gold standard methodology of IVUS. I personally would not make a blanket statement that people should only have the procedure done as part of a clinical trial in a situation where (and correct me if I'm wrong) for all practical purposes it is essentially impossible to get enrolled in a clinical trial. And I believe that there are SOME reputable doctors doing the surgery outside of a clinical trial (am I mistaken or is Dr. Sclafani not currently participating in a clinical trial?) and where some people are running out of options as their disease progresses.

In addition it appears possible that some clinical trials may be being done by doctors who are not experienced at conducting CCSVI PTA procedures. I would guess that credentials, experience and using gold standard methodologies is more relevent to individual patient procedure outcome than whether or not the procedure is done within a clinical trial setting!

Personally I would not advise a person about whether or not to get the procedure at all. I would advise them to research the pro's and con's (potential risks and benefits), seek out the professional health care advice of their choice, and make their own decision based on their own individual circumstances. For instance Annette Funicello: I think it was just fine that she had the procedure despite the fact that it was not part of a clinical trial, but I wouldn't have advised her one way or the other, the decision was up to her and her family members.

And this part of your last post:
Having ANY well known CCSVI doctor act as the Lead investigator in any future Trial ... won't fly with those still opposing the concept of ms being treated via CCSVI.

I feel like I already responded to this yesterday, but now I can't find my response, so my cog fog must be worse than I thought. At any rate, my question about this part of your post is: Do we even need to pay any attention to whether or not "they" approve of us having a competent, accomplished, CCSVI experienced, Interventional Radiologist conducting a trial? I think we should just raise the money and do it! A Kickstarter campaign might be a good place to start, overseen by the CCSVI Alliance or some other reputable nonprofit that is eligible and trustworthy to receive and account for the donated funds.

At any rate my take on what we know about the PREMISe study so far is that yes, they said its safe, which is a good thing, but they also said it might do harm, so those two statements kind of negate each other in my mind, which is not a good thing.

They also say it didn't appear to result in any improvements, and if it turns out that it was a well designed trial, that result is not encouraging. If it turns out that it was not a well designed trial, its still not a good thing because people (neurologists) will hold it up as more "proof" of why future studies shouldn't be funded.

So this gets me back to the fact that we really NEED to have a trial where the procedures are done by a well respected, accomplished, interventional radiologist who has A LOT of experience conducting CCSVI PTA using gold standard methodologies such as IVUS. In my mind, this is Dr. Sclafani.

Is he willing to take part in such a trial? Can we raise the money to make it possible?

If the trial has positive results and the neurologists don't believe the results, then it will be up to them to try to disprove it by replicating the study USING THE SAME METHODOLOGIES. If the trial doesn't have positive results, then we will have to live with the reality of that. But either way, at least we'll finally have hard facts to base individual health care decisions on.

How is it that anyone can doubt that a complex medical procedure would require proper tools, as well as extensive training and experience, before outcomes would be positive?
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Re: PREMiSe study results

Postby Cece » Mon Mar 18, 2013 10:40 am

ThisIsMA wrote:Were these procedures conducted by a neurosurgeon instead of an interventional radiologist???
The procedures were done by Dr. Siddiqui who is a neurosurgeon. No IRs involved.
How can there be "no difference" in one quote, and "increased brain lesions" in the other quote?

It could be that there was a difference but it did not reach statistical significance. We really could use a full paper with all the details.
O.K. the fact that they used the word "sustained" makes me suspect that the at least some if not many or most of the treated patients may have had temporary improvements. This is another hint that they may have been under-treated and then re-stenosed.

No sustained improvements...if there were temporary improvements from placebo, you'd expect them to be equal in both groups. It was interesting that the placebo group had a small improvement in hemodynamics, equal to that in the treated group. There used to be speculation that just running a catheter through the veins could be beneficial.

On a side note, the trial required a stenosis to be 50% in order to treat, which is a standard for arteries but not for veins, as Dr. Raju explained at ISNVD 2013. The standard in veins should be lower.
And what I really mean by that is that I suspect that at least those of us in the USA and Canada should be putting all of our donations and efforts into helping fund a trial where the procedures are done by Dr. Sclafani himself. Dr. S's credentials and intentions are impeccable. We all trust him.

How can we make this happen?

I was recently looking at the Kickstarter model. They fund projects but not medical research projects. It's still a useful model. A goal is set and everyone pledges and the pledges are only collected if the goal is reached. http://www.kickstarter.com/help/faq/kic ... cs?ref=nav

ThisIsMA, what do you think about this? https://scopeblog.stanford.edu/2012/07/ ... -medicine/
"medstartr" and "IAMScientist" for crowdfunding medical research. Maybe this is what we need?
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Re: PREMiSe study results

Postby ttucker3 » Mon Mar 18, 2013 1:02 pm

With a patient sample size of only 20 patients the “margin of error” is rather large – about 22% at the usual 95% confidence level (see “margin of error” in Wikipedia). In comparison the margin of error, if the patient sample size were about 1000 patients, would only be about 3%. This, I would suggest, may cause UB to seek funding for a much larger study in order to increase the accuracy and reliability of the results.

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