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Press Briefing Transcript

HHS call with Sec. Thompson, and Drs. Koplan, Fauci and Henderson

December 18, 2001

HHS MODERATOR: Good afternoon. Welcome, everyone. I just would like to remind you, before I turn it over to the Secretary, try to limit your questions to one and a very brief follow-up. Thank you.

Mr. Secretary?

SECRETARY THOMPSON: Thank you, Bill, and thank you, reporters, for all of you that are on the line for calling in today.

Joining us on the call this afternoon are Tony Fauci, from the National Institutes of Health, and Dr. Jeffrey Koplan, from the Centers for Disease Control, is still up on Capitol Hill and will be joining us shortly, but is not here yet, but we're expecting him momentarily, and also Dr. D.A. Henderson of our Office of Public Health Preparedness is with me here in the office, and Kathy Zoon, from FDA, the Food and Drug Administration is on the line as well.

Many of those who are exposed to anthrax and the terrorist attacks are concluding their 60-day treatment of antibiotics. This course of treatment has proven to be effective in the 2 months since the attacks, and we are committed to protecting the health of people who were exposed in the attacks. Some of those people, especially those who may have been exposed to high levels of anthrax spores, may wish to take additional precautions beyond completing the 60-day antibiotic regimens.

Therefore, out of an abundance of caution, the Department of Health and Human Services is supporting two additional options beyond the 60-day antibiotic course for those who may wish to take additional options. One additional option would be to continue to take antibiotics for another 40 days, while closely monitoring for illness or adverse reactions to the antibiotics.

Another is to continue taking antibiotics for another 40 days, as well as to receive three doses, and I underscore that, three doses of the anthrax vaccine spread out over a 4-week period. As an investigational new drug, the vaccine would have to be given with the full informed consent of the individual as to possible risks. Those receiving the vaccine would also be asked to take part in a follow-up study to determine the effectiveness of the vaccine when it is given after exposure. Those individuals who may wish to take antibiotics longer or get the vaccine should consult with one of their physicians.

We also are putting out here a third alternative, and that is to continue and watch yourself, and if, in fact, you get sick, to go to a doctor to be examined.

I would now like to turn it over to Dr. Henderson, and then Dr. Fauci, and then Kathy Zoon, and by that time Jeff Koplan should be here.

And so Dr. Henderson, will you say a few words.

DR. HENDERSON: The recommendations which you hear, let's say the options which are presented stem from discussions that we have had pursuant to a meeting we had on Saturday, some 4.5 hours, in which many people participated, in which all of the information that is available was laid out, and there was an opportunity for many questions from those in the audience and many comments as well.

Taking all of that information together, we've had deliberations since that time with the Secretary and others who are on this line, and these are the conclusions which we reached. I would note that the data supporting, say, giving more vaccine or giving vaccine are very slim, indeed; that is, we don't have a lot of information about this.

Anthrax is a rare disease, and so that the vaccine used in this way would represent a different way of using vaccine than it's been used before. Before it's been used to protect people before exposure. Here we are providing vaccine after, 60 days after, to give them antibodies, so that they might be protected against a risk.

People ask what is that risk beyond 60 days. I would just like to repeat something the Secretary said. We've had no cases of anthrax in humans beyond 43 days, but the 60-day course of antibiotic therapy has served us well, we do believe. The possible risk of cases after 60 days is based solely on a very limited amount of data from animal studies. The data are there. They raise a question of possible risk, but this is the best we have to go on.

As the Secretary has said, what we're looking at is the interests of the people who have been exposed, our concern for those who might have been exposed to very heavy concentrations of spores, and so these are the options that are presented at this time.

Thank you.

SECRETARY THOMPSON: Tony Fauci and then Kathy Zoon, and I just want to inform everybody that Dr. Jeff Koplan just walked in. So Tony, and then Kathy, and we'll give Dr. Koplan a chance to collect his thoughts before he says anything.


DR. FAUCI: Yes, okay, Mr. Secretary.

Just to extend very briefly what D.A. Henderson just said, it's important to appreciate, and this was brought into detail at the meeting at the National Academy of Sciences on Saturday, is that the scientific data, as D.A. mentioned, is a slim amount to indicate that this would be helpful.

However, there's theoretical--and I emphasize "theoretical"--reason to believe that this might--might--provide some benefit, and it has to do with the persistence of spores in animal models following inhalational anthrax challenge, that has gone out to several weeks, up to and even beyond the 60-day time period, where the people who were recommended to have antibiotics were on antibiotics, and that's just a theoretical consideration.

Because of the theoretical consideration and not the firm scientific data to indicate that this might be effective, and because of the use of the vaccine in a use that had not been approved for, namely for therapeutic purposes post-exposure, as it were, it's for this reason that the procedure will go under an IND or an investigational new drug, which will require full disclosure as to what the risks and potential benefit are, as well as the final decision made by the patient in signing an informed consent, which is an important part of an IND.

And we anticipate that there will be a broad range of responses of people who might not want to participate and those who might feel strongly that they would want to participate. And it's for this reason that the Department is offering this as opposed to making a strong recommendation.

SECRETARY THOMPSON: Thank you, Tony. Kathy Zoon?

DR. ZOON: Yes. I think, Mr. Secretary, based on the comments that you've made, and Dr. Henderson and Dr. Fauci, I don't have a lot of additional information to add other than that we are working with the Department on this very important issue, and that I'll be happy to answer questions that may arise on FDA matters.

SECRETARY THOMPSON: Thank you, Kathy. Jeff Koplan.

DR. KOPLAN: Glad to be here. I'll wait for questions.

SECRETARY THOMPSON: We'll now take the questions. Dr. Koplan, Dr. Fauci, Dr. Zoon and Dr. Henderson, and Claude Allen and myself, along with Dr. Zucker.

AT&T OPERATOR: Thank you. At this time we are ready to begin the formal question and answer session. If you would like to ask a question, you may press star 1. You will be announced prior to asking your asking. To withdraw your question you may press the pound key. Once again, to ask a question, please press star 1.

Ms. Laura Meckler from the Associated Press, you may ask your question.

QUESTION: Hi. Two questions. One, do you know--do you have any sense or any prediction as to how many people will take you up on either of these offers?

And secondly, do you know how many people have not, who were recommended for the 60 days, have not taken the full 60 days? Do you have any sense of that?


DR. KOPLAN: We don't know the number who are likely to take up on the offer. That's being discussed now, and it's too early to know what that number's going to be. We think it will be a smaller fraction than the total number of people to whom it will be offered, but we're not sure what that number will be yet.

There have been variable numbers, and depending on location and source of exposure of how long people have stayed on the antibiotics, some have stayed on. 80 percent of them have completed the full course of 60 days, and in other instances it's been more like 60 percent. So that in whatever the group is, as we all know from taking antibiotics ourselves, it is difficult to stay on even for a 14-day course. For a 60-day course it's quite difficult.

QUESTION: Can you say where the high and the low was, what group was 80 percent and what group was 60 percent?

DR. KOPLAN: We haven't finished analyzing all that data yet.

QUESTION: Thank you.

HHS MODERATOR: Next question, please.

AT&T OPERATOR: Ms. C.C. Connelly from the Washington Post. You may ask your question.

QUESTION: Thank you. As I understand it, to go forward with an IND, do you need a recommendation from an institutional review board? I'm wondering if someone could tell us who that is in this instance and when this IRB made its recommendation presumably in favor of post-exposure vaccination?

DR. : CDC's Institutional Review Board reviewed the use of this for post-exposure this past Sunday and approved its use.

QUESTION: And just to follow, maybe you could tell us a little bit more about, is that a document the we can see, and could somebody tell us or preferably provide us with a copy of the informed consent?

SECRETARY THOMPSON: I'm sure we could, C.C. I don't know why not.

QUESTION: Great, thank you.

HHS MODERATOR: Next question please.

AT&T OPERATOR: [Inaudible] Niergard from the Associated Press.

SECRETARY THOMPSON: C.C., why don't you contact our public relations office and they'll contact the Office of General Counsel and we'll make that available to you.

AT&T OPERATOR: Lauren Niergard from the Associated Press, you may ask your question.

QUESTION: How soon will the first vaccinations be offered, and what are the actual sites that your statement makes reference to people consulting not only their physician but a physician at a site where the vaccine is being administered, who's really the PI on this since it technically is a study.

DOCTOR: Well, it's my understanding that those in Senator Daschle's suite will be taken care of by the physician to the Congress, Dr. Eisold, will be seeing to that. There have been contacts made both with those in the union and the Postmaster General to try to determine where best to offer the vaccine for those in the--postal workers who are involved.


QUESTION: So are those specific sites around the country or is this only clustered in D.C.?

DOCTOR: That hasn't yet been determined. I presume it will be based upon the individuals that are requiring them, or requesting them.

HHS MODERATOR: Next question.

AT&T MODERATOR: Mr. Sam Carvindantem [ph] from the Washington Post, you may ask your question. My question is as Dr. Eisold said on Saturday, eh had planned to vaccinate people on the Hill combined with antibiotics in the event of an anthrax emergency, and given that CDC requested an IND a month ago from the FDA, outlining a proposal to vaccinate people, and given that you requested the vaccine from DOD about a month ago, why are you making the proposal now instead of a month ago, or instead of two months ago?

SECRETARY THOMPSON: Who are you directing the question to?

QUESTION: Anyone. Especially you, Mr. Secretary.

SECRETARY THOMPSON: I'm doing it now because the doctors and the scientists who advise me had their meeting at the Academy of Science on Saturday and reviewed all the medical and scientific data, and they made a recommendation to me over the weekend, and I decided today, and decided the best way to explain it to the press was to have this teleconference.

QUESTION: Could you also--

SECRETARY THOMPSON: You know, it also, it precipitated, of course, is the fact that the 60 days are up now, and the medicines, Cipro, for those individuals that have adhered to the 60-day regimen have completed that. Or will complete it, I believe on this Saturday.

QUESTION: Okay. Could you also tell us why you requested only 10,000 doses of the latest batch of vaccine from DOD. As you know, there has been some confusion and controversy about the vaccine, and which doses and which batches will be used in this vaccination program?

SECRETARY THOMPSON: Well, it's a means of negotiations that went on between us and the Department of Defense. This is a vaccine that the Department of Defense has and they were kind enough to sell us 220,000 doses, and this is what they would sell us.

DOCTOR: I think we can also note that if we look at the people who may have been exposed to heavy amounts of spores, we're estimating that there are probably less than 3,000 people who would be eligible, who really be at risk based on this concern that people may have taken in rather more spores than we normally would expect, and if one multiples, even if everyone wanted the vaccine, we would still have need for less than 10,000 doses.

QUESTION: Mr. Secretary, could you also tell us how much you've paid for the vaccine.

SECRETARY THOMPSON: I can't remember. I think I purchased for exactly what the--I reimbursed the Department of Defense what they paid for it, and I can't remember that number.

QUESTION: Thank you.

SECRETARY THOMPSON: I made them whole, is what I did.

HHS MODERATOR: Next question, please.

AT&T MODERATOR: Miss Susan Lilly [ph] from CNN, you may ask your question.

QUESTION: Good afternoon and thanks for holding the call. My question is about the 60-day period. We know that the Daschle letter was opened on October 15th. We're now at December 18th. I'd like you to please clarify when the vaccine will start to be administered, but also that's more than 60 days, so certainly we're talking about people who are concerned, the people who want to take this extra precaution. What can you tell them about the delay, if they finished their antibiotics three-four days ago?

DOCTOR: I think the fact of the 60 days is not a magical figure, if you will, that people would have to begin right at 60 days with vaccine. There's no reason why they can't go on. In fact it's been recommended that they continue for a few more days yet with antibiotics, because there are a few that already have passed the 60-day mark. So I don't think this is a critical date that we really need to be that concerned about, but I think we do want to get the vaccine to the people in due course, and so we're moving ahead on that.

But I would not look upon that 60-day date as being that critical.

QUESTION: And when will you start administering the vaccine?

DOCTOR: We would hope to begin vaccinating in the Senate as early as tomorrow, possibly the following day. There's certain pieces of paper and legalities and things that have got to be sorted out yet, but they're getting sorted out. Talking with the Postal Workers Union and the Postal Service, they've asked that they, to do an educational program for perhaps another week, and to inform their workers, and so they would be continued on antibiotics at their request, and perhaps then their vaccination might begin next week.

But it was their request, that they would like that time to have the opportunity to fully educate their workers as to what the pros and cons might be of any of these three courses.

HHS MODERATOR: Next question, please.

AT&T MODERATOR: Mr. Rick White from the Washington Post, you may ask your question.

QUESTION: Thank you. You know, a month or two ago, on one of these calls, soon after CDC had filed its IND for post-exposure use of this vaccine, I asked whether you were anticipating using this for this purpose, and was told no, the reason you were actually filing the IND was because there might be some people who ended up, who proved to be allergic to all the available antibiotics, and for those people there was evidence that the vaccine might be more useful than nothing.

What is the reason that you were not willing or able to be more open, from the beginning, about what you were working toward here?

DOCTOR: I think we were perfectly open from the beginning. The issue was that we've gained further information on a daily basis from that time to now, and having the IND available for post-exposure prophylaxis gave us the opportunity to use it any one of a number of ways. But the information we've gained from the--or the lack thereof from the case in New York and the case in Connecticut, from continued review of the nature of the exposures in the various other sites, and then a further reflection on the literature with both people inside and outside of government have led us to where we are today.

The fact that this wasn't an obvious thing at an earlier time doesn't reflect any attempts at preventing disclosure, it reflects a continued evolution of scientific concept in this ongoing problem.

QUESTION: So this was not even an option that you were considering when you first got this IND?

DR. KOPLAN: It wasn't one that sprang to mind then. One of the things that we were concerned about was an ongoing influx of new cases and then what were all of our options going to be as this played out into the future, and having this IND in place gave us an option that we didn't have in hand.

QUESTION: Thank you.

HHS MODERATOR: Next question, please.

AT&T MODERATOR: Is Laurie Garrett from Newsday. You may ask your question.

QUESTION: Thank you. Do you have any basis for making any determinations about how people will be able to handle this vaccine that are not in the age group that the vaccine was designed for, meaning young military recruits, and so on, and, in particular, when you're talking about people who may be HIV-positive, may be post-transplant, may be over 65, et cetera?

DR. KOPLAN: There is no good information on this, at the moment. As you've just indicated, Laurie, this vaccine was both designed--well, not so much designed, but mostly used, our major experience with the vaccine has been in selected occupations over the years, again, all of whom are usually healthy. They tend to be male, and they tend to be in their middle or younger ages. And then certainly in the military, it's healthy, young males predominantly, as it might be used in this postexposure prophylaxis condition. It covers all of the groups you've talked about.

We don't have data for large numbers on those. Even if we had experience with such a spectrum for 5,000 or 10,000, that's still a relatively small number on which to base adverse reactions, as we know from many other vaccines.

QUESTION: Can I follow up and ask what are you doing, I mean, where is the liability going to be here? Besides, obviously, doing informed consent up front, what are you going to do to ensure against, given how many lawsuits already were filed against the military, against you for this vaccination campaign?

DR. KOPLAN: I have been on the road today, Laurie, so I can't answer that myself because this is being discussed, and we're trying to sort that out.

SECRETARY THOMPSON: Stuart, why don't you say.

DR. : We're treating this the same way that the Department of Defense has treated it. We're indemnifying BioPort, the manufacturer of the vaccine, to the same extent that DOD has.

HHS MODERATOR: Next question, please.

AT&T MODERATOR: Ms. Eunice Miscoso [ph] from Cox Newspapers, you may ask your question.

QUESTION: Thank you. I wanted to ask the past experience with the vaccine, if you could tell me some of the side-effects, the common side-effects of that vaccine that people can expect that are going to take this vaccine, just the common side-effects and how often they happen.

HHS MODERATOR: Kathy, do you want to comment on that?

DR. ZOON: Yes, I could just mention the major reaction of the vaccine is a local reaction, where there is edema, and redness, and swelling at the site of injection. These actually can be quite dramatic in terms of that side-effect. There have been other side-effects reported through our VAR [ph] system, but there is no pattern of other side-effects. There's been reports of fever of some sorts, and we collect all of our adverse event data through the Vaccine Adverse Reporting system and are constantly reviewing the adverse events for trend analysis or pattern analysis.

But, to date, there haven't been, beyond the swelling and redness, and in some cases some allergic response, but other than that, there's no pattern, but we are going to continue to look at these side-effects very carefully.

QUESTION: How long does the swelling last? Is it--

DR. ZOON: It can vary. Generally, it's from days to weeks.


HHS MODERATOR: Next question, please.

AT&T MODERATOR: Ms. Susan Denser from the NewsHour with Jim Lehrer, you may ask your question.

QUESTION: Yes, thank you. Two questions related to studies.

First of all, the mention of the animal studies on which the theoretical presumption is made, that the vaccine may be effective, are those the same old animal studies that have been referenced in the past, with respect to monkeys, or is this a new version of studies? Are there newer studies on which this presumption is made, first of all?

And, secondly, with respect to those who will now elect to get the vaccine and thus become enrolled in what is, in effect, now a clinical study, will there be another arm of the study that includes those people who do not choose to take the vaccine? Will they be evaluated against those who do?

SECRETARY THOMPSON: I think Tony might want to answer the question about the resistance of spores.

DR. FAUCI: The animal studies are fundamentally two. Well, there are a few, but the two best, from the standpoint of the discussion that has gone in the medical community, is a 1993 paper from Art Friedlander in the "Journal of Infectious Diseases."

And when I said in my opening comment that the scientific data was really weak vis-a-vis a scientific proof or indication that vaccine plus antibiotics versus antibiotics alone is of significant benefit relates to a small number of monkeys in which there really was no statistically difference between animals who are challenged with inhalational anthrax who got antibiotics alone, and then the antibiotics were stopped and then determined how many animals got sick after that versus those who got vaccine plus antibiotics post-exposure and then the antibiotics was stopped.

So there's no significant difference there. However, within that study and within another study that was done earlier in 1956 by Henderson, et al.--no relationship to D.A.--that study--

SECRETARY THOMPSON: Tony, I don't know about that. D.A. is shaking his head that that's his long lost cousin.


DR. FAUCI: Well, if it's his cousin, congratulations, D.A.

But in that study, together with the Friedlander study, what was clear was that when they took the animals and did pathological examination of looking for spores in the lungs, they found that there were spores as far out in one study as 45 or more days, and then in the Henderson study, they found trace stores up to 100 days. At 75 days, they found .5 to 1 percent of the challenged spores still in the lung. So, based on that, that is a theoretical consideration that there may be persistence of spores.

Now, importantly, none of those animals were treated for 60 days. In one study, the animals were treated for 10, and then in the same study for 20 days. So it isn't comparable, but nonetheless the major theoretical consideration relates to the persistence of spores and not to any significant difference between the group that received vaccine plus antibiotic versus antibiotic alone. So it's on that basis that those studies are being used.

Now, your second question? I'm sorry.

QUESTION: With respect to what is now going to be this new clinical study involving those who do elect to get the vaccine, will there be a second arm?

DR. : Well, we'll actually, as the Secretary mentioned, there really are three options. The first option is to just stop, as many people have done, and just wait and be careful to be alert to any symptoms or signs, and make sure you have access to a physician in case you do.

I might mention, of note and of interest, that in those individuals who have not adhered to the 60 days, namely groups of individuals who have stopped after variable periods of time, as well as other individuals who have actually finished their 60 days. There have been no cases at all of a later onset of inhalational anthrax related to what we would call the persistence of spores.

Getting back to the study, the first limb is: don't do anything. Stop and just watch carefully and be attentive. The other limb is to continue antibiotics alone for an additional 40 days and not to take the vaccine. And then the third is to continue antibiotics but to take the vaccine, and then after 40 days stop.

So in reality there really are three limbs to the options. Now, how many people are going to choose one versus the other is going to determine the power of whether or not you're going to get information that's useful vis-a-vis the clinical benefits.

What one will get, no matter what, is safety data for the use of this vaccine under the circumstances that we're discussing, as well as antibody data indicating what the immune response to individuals would be under these circumstances.

QUESTION: So the final analysis, whether you have enough people who elect the other options, the non-vaccine options, to amount to--to give you enough statistical power to do a study, that remains to be seen?

DR. : That remains to be seen. That is indeed correct. But as D.A. and the Secretary mentioned, of the larger cohort of people who were suggested and urged to take 60 days, it is anticipated that the group of high exposure individuals, when they sit down and discuss the risk benefit within the framework of the IND with their physicians, it is highly likely that there will be a much smaller group of individuals who will elect to take the vaccine.

Now, D.A. mentioned the idea of 3,000 in the corps as heavily exposed, and likely that not all of those will elect for the vaccine. So you're really talking about a significant number, who will, out of necessity of deciding they don't want the vaccine, will either stop cold and observe, or continue for an additional period of time on antibiotics alone.

QUESTION: Okay, thank you.

HHS MODERATOR: Next question, please.

AT&T OPERATOR: Ms. Cheryl Stilberg from the New York Times, you may ask your question.

QUESTION: Yes. I'd like you to talk about why you have not made an explicit recommendation? I'm sure you must have discussed whether or not to recommend to people that they take the vaccine. And I would think that if it were among those 3,000 people, I would frankly be a little bit disappointed that the collective wisdom of the anthrax experts in this country weren't telling me what I was supposed to do.

DR. HENDERSON: Well, let me--this is D.A.--I'll respond to that. I think we're, in medicine, often faced with difficult decisions based on really inadequate information, and this is certainly where we are here. If this were a vaccine which was indeed--had no associated reactions which would work very well, that would be one thing, but this vaccine does have reactions associated with it, so there's a negative side to it.

We have the question of the antibiotics. It would be nice if we had no reactions to antibiotics, but in fact, there have been quite a number of people who had quite distressing symptoms as a result of taking antibiotics. So to be taking another 40 days on top of 60 days may be a very unpleasant experience indeed.

And we have then finally the question of risk, which as Tony has pointed out, is a very mild, minor risk, indeed. It is not zero, however, and we would love to be in a position of being so wise and having so much information behind us, that we could say, well, go ahead and do it, there's no risk and there's no problems. But there is risk and there are problems in taking any one of these courses of action.

So what we tried to do in this case is to lay it all out and say here's where we are, this is what we know, and there are three options out there, and the question, what any one of us would do, I suspect we might differ among ourselves.

We could have a group of graybeards that sit in a room behind closed doors and come up with a very firm recommendation, but that we don't have. We chose to try to be fully open with just what we know, and what we don't know, and to share it with you, just where we come out.

QUESTION: And then following on that, the question of indemnifying BioPort, does that indicate that you are concerned that there will be some law suits associated with this, that people might try to come after the Government should there be some adverse reactions?


DOCTOR: No, that was just, those are just the terms of the transaction with the Department of Defense.

HHS MODERATOR: Next question, please.

AT&T MODERATOR: Miss Maria Gillespie from the Fox News Channel, you may--

HHS MODERATOR: By the way, this is going to be--I'm sorry--this is going to be our last question.

AT&T MODERATOR: Ms. Maria Gillespie from the Fox News Channel, you may ask your question.

QUESTION: Hi. Thanks for having this call. Previously, I understand that the military were given six shots over 18 months, and now you're going to give three doses of it for a week. How did you come up with that and why?

DOCTOR: I'll be happy to respond to that. For the military, we're looking for pre-exposure vaccination protection, so that the idea is to give them vaccine before they might be exposed, and to provide them the degree of protection that is felt to be necessary, one is not only going with the three doses, but then one is looking to protection going out into the future, over years, and this is quite a different situation.

Here, we're looking at quite a different situation in which we're looking to provide the individual with antibodies for the very much shorter period of time, and what we've seen in studies with monkeys, that if you give them vaccine at three doses at two week intervals, that they do get antibodies by the end of the third dose, and thereby there are antibodies present, and then the protection will extend out for a period of maybe months. But it's not in the framework of years. so that this has been experimental work.

I'd like to come back and just to clarify a particular response I made earlier, and that is with regard to the availability of the vaccine. We're quite prepared to arrange for vaccination at any time, beginning any time the vaccine is available, and what is needed at this point is to make arrangements for the proper place, and as I say, I think we could begin as early as Thursday with everyone. It's just a matter, now, of consulting with those who would be receiving the vaccine, to find out what is most convenient, and what they would wish to do, and those conversations are in progress.

As I mentioned there was interest on the part of those in the Postal Service of having an educational period of perhaps a week, and that's fine, and they can certainly take antibiotics in the interim, and we'd feel very comfortable with them doing so, and they may or may not at the end of that week decide to go on, and to take more vaccine, or to take vaccine or take more antibiotics.

So I don't think there's any really great issues, or, really, urgency about moving quickly, as I mentioned earlier, in moving with the vaccine.

HHS MODERATOR: I want to thank everybody for joining us this afternoon.


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