Working In Oncology
Working In Oncology

Episode · 2 months ago

Using Expanded Access & “Right to Try” for Experimental Drugs w/ Ajeet Gajra

ABOUT THIS EPISODE

For patients who have run out of approved treatment options, hopes of fighting disease can feel diminished. Fortunately, through existing and new programs, patients have access to alternative drugs. Educating physicians more on the program availability can lead to an increase in options for patients and a more positive outlook to recovery.

Dr. Ajeet Gajra, Chief Medical Officer at Cardinal Health Specialty Solutions, joins the show to discuss experimental oncology drug use through the Expanded Access Program & the Right To Try Law.  

Here are the show highlights: 

- Expanded Access Program vs. The Right To Try Law

- Hesitancy & Barriers to Use Programs

- First Steps & How To Stay Up-To-Date on Programs

- Tips for Office Staff w/ These Programs

- Success & Future Use of Drugs 

Check out these resources we mentioned during the podcast:

- Dr. Gajra’s LinkedIn (https://www.linkedin.com/in/ajeet-gajra-md-mbbs-facp-77059748/

- Dr. Gajra’s Research (https://ascopubs.org/doi/full/10.1200/OP.20.00569)

- Cardinal Health (https://www.cardinalhealth.com/en.html)

 

To hear more interviews like this one, subscribe to the Working In Oncology Podcast on Apple Podcasts, Spotify, or your preferred podcast platform.

You are listening to working inoncology. A podcast and video show that spotlights ontology practice staff andindustry and florences who work behind the scenes to shake the feature of acology, the more knowledge the ecologycommunity shares with each other, the more we all grown, let's get into theshow, welcome to working in oncology undercost for the day, alicia evans i'm joined today by doctor ajib, gosa,chief medical officer at cardinal health, specialty solutions and co.Author of a recent study published in j c, o oncology exploring requests foraccess to experimental drugs. Doctor gaja. We thank you for coming to theshow today and welcome palisot you so much for having me, i'm happy to behere and very eager to talk about this important but often ignored a topicabsolutely so i've been really looking forward to our conversation. Theirsandy was pretty eye opening and i think you can really help kind of fillin some knowledge gaps today that will help our listeners really expand theirpatient's excess potentially to experimental drugs. Sure so before wejupin the conversation, can you tell our listeners and viewers a little bitmore about you, your background and what you do sure she s. So, in mycurrent role, i serve as a chief mescal officer. He had cardinal health,specialty solutions, and i've been here for two years now, but at heart i'm aclinical. You know medical oncologist and hemolysis and the start of thejourney was back and there was combating myself back in the late swhen i chose the field of hematology ecology to pursue after intermeantraining, because i always thought you know, college is the ultimate barriersort of, and you know other softens written about the cancer being theemperor of all maladies- and i felt like that that that is so true and werethese was so true to me back in the day. So you know this. Video has been verygratifying because it's afforded to me my three loves, which is clinicalresearch, education and, of course, patient care, which is close to myheart, and i was able to serve veterans by you know working part time at thevacate er. I've spent most of my time in academic practice, till until twothousand and seventeen when i made a transition to industry focused onatlantica research, and then he or cardinal continuing that kind of work.It seems like you've, had kind of an extensive oncology kind of rage ofexperiences. Certainly- and you know at the cliopractice, even though i was an academic practice, i had the opportunity to workin a community setting in a large aturaa cancer center and, like i said,also in a different system of which the ba system is the unique system. So ihave the benefit of all three you know...

...being able to compare and contrastalmost with a good bad of each of those. So before we jump into what we want totalk about today. Is your recent research on the use of expanded accessand right to drive requests, and i hope you think cherubs of his conceptionsabout the two programs and maybe discuss maybe the ins and outs of eachsure. Yes, so you know this is interesting because, while in practiceand currently i'm not in active practice, i e patient, as were in a vatof the basis. But you know i have the opportunity to be exposed to and workwith, the expanded access program myself and in fact, the first time iused it for a patient who had a reniform of lung cancer would runthrough all of their treatment options. But you know the patient in the familywere still wanting to try for something else, and so looking through theclinton trials website, i found that there was a drug which was hin beingtested, but i was not faunt available. So then i was able to reach out to themanufacturer, was willing to. You know, give out the drug this patient and wehad to jump through several hoops, so we had to first and foremost get transfrom our institution review board, for a protection of you know, cations bestinterest and then get to some men, a request to the fda. So this is, ineffect, sums up the expanded access program where a drug which is available.It may also be used in other settings but can be tried an indication or in adisease where it's not currently approved, but you have to get your irvapproval and up again an fda sign off and and then and of course, themanufacture, the bio form a company has to be willing to offer this drug to thepatient. Of course, there's an informed consent process, so this effendina'sprogram has been in parlance has been in use, since the late is one thousandnine hundred and eighty seven i believe, and has had literally hundreds ofthousands of patients gain access to agents outside of a clinical trial. Youknow that they might not have had access to. But again you know if youare a busy provider, as many of our listeners might be, it seems daunting.Oh for a single location, i have to go to my rb. I have to go to the fda. Thisthis seems like i just don't have the time to do it, but it is very feasible.It's doable and, of course, once you learn how to do it and the more supportyou have in your institutional, practise, the better. You can do it nowfast forward to two thousand and eighteen, a new methodology of her newprocess. New pathway was signed into law called the right to try and thedifference between expanded ashes at right. To privately is that we ride totry, you don't have to go to the irb. You don't have to go through the fdasigner, so obviously it's a much abbreviated process. However, however,the manufacturer still has to be willing to provide the drug, and alsothey are very clear and straight...

...criteria for what patient, whatindividual can qualify for right to dry. So for that really three things have acane man in terms of their disease, so they have to have a life of threateningdisease. They have to have used up all available and f approved therapies.They cannot, you know they should not either qualify, work, local trial orshould not have access to one and so and of course, they still have toprovide written, informed consent. So those are sort of the patientessentiality es to qualify for right to try, but then there's also the otherconditions that have to be met which are for the drug. You know so numberone phase. One studies should have been completed because we want to make surethat we at least have with those which has been identified, and you know thatsafety has been assessed, and you know it's perminent to be safe for usinghumans, so phase men testing should have been done this agent if anyone'sgoing to apply for right to try should not could not have been approved orlicensed by the efer any use. So it's not like. Okay, i have it is drawn inworks in lung cancer. Can i use a breast cancer and office f b approvalalready? Then you cannot access it by right to tron, and the third is thatyou know the manufacturer should have already filed an ind application in theface, of course standard, but there cannot be a clinical home. So sometimesthe f will notice that oh there's, maybe a problem or maybe a safetysignal or some concern with an agent as it's being developed, and so they mightput a torticol on the ind. So again you know so if there's a clinical home,then that drug cannot be access to right to try and again it's tosafeguard the patient's interest, because the fda put a hold on it for areason and for safety or some of the concern, and so that we don't want toannoy expose a patient to such harms. Dina long answer, but that's an overview of these twoexpended access and right to try. There are some other terms that come up.Sometimes compasionate use. Yes, so you know you bring up a very valid pointalicia. So compassionate us has been long used quite honestly to describethe expanded access program, because what we were doing to that as helpingour and still are, is- and when i say we i mean, as on college, is asfollowin colleges. It is a method of getting access to a drug which, forwhich is not approved or indicated by the label, in a given patientscondition. So if a drug is approved for i give you a example- and you know whenyou're on colleges and awful for listeners now that you know neighborsfriends, family all reach out to you. So you know there's someone thatreached out. Unfortunately, they had, they have a brand to er. They havebrain cancer, renew vestila and they have you know already used of the twoto three standard prefrent options, and...

...so they really want to try him in oftherapy. So you know, but amenotaph is expensive and it's not approved for thebest to so so they are obtaining this mino ter pin medication the an expandedaccess program. So in a way it is compassionate ens, but come tomanufactures willing to provide that. But right to try in a way is also aform of compassion of you. So i guess my point is that compassion of vous isa broad term, you to eyes for off label, which is another term blouse of thesedrugs, which are not approved by the fda for a given disease. But again theyhave to be provided by the manufacturer, and i think that is a part of thecompassion the compassion at us is coming from that you know themanifactur is willing to write access to these agents. Okay, and so this kindof brings us back to your research, and i mean we've already established thatthese terms are sometimes use, interchange, ably mistakenly and inyour research. I was very surprised to find that such a small percentage ofproviders had attempted the right to try pathway, yes, alesia, you know, so that was apart of the reason why we conducted this so it had to in my role here acardinal. I support also one of the divisions called a cardinal healthregulatory sciences. So there's a whole. You know a great team of scientists andpharmacists and other regulatory specialist and that division that workwhen fdno their agencies to get a drug from the pre ind ind to you, know finalapproval stage so anyway. So, as you pointed out, there's even in people whoare, you know very well well worse with this work, there can sometimes beconfusion in terms of of label, compassionate us and then eap, expandedaccess and ritter, so to or summits so cardinal conduct summit meetings ofproviders, physicians, but also sometimes apps like an pesin, but thistry was directed at words, positions to assess if they understand thedifferences is between a right to try and expanded access. Now, even thoughwe conducted this late, two thousand and nineteen to early two thousand andtwenty you know, perhaps we were now onthinking about publishing this, but then, unfortunately, as we all know,the pandemic happened and as we nail the access to medication in this caseantivari or who was hoped to be a devarata py. You know that we heard somuch about compassionate views of the areas drugs for coin nineteen, and sothat made us think. Like oh we're, i mean we had the information already.So, in fact, that was a reason to for us to go ahead and publish our findingsor report our findings, because among some cologist you know the the systemserector tors on college drugs, but we...

...also in our work, and we should realizethat you know this has been done for a community based on colleges in the pastand rely the most for the reasons to report this in jc comedy practice. So in some ras what you're, researchingthrough of research rather is kind of an assessment of physician's knowledgeof these programs and their experience with each of these programs exactly toknowledge and utilization. So do they know about this, have the utilized, andwe also want to ask them if they ulie it. What is their success rate? Arethey able to gain access with the drug that they requested or not? So andagain, you know in a spiritful dispute and we say that healed in our paper.This is simply based on a survey on recall, so it's not like we're askingthem for you know specific evidence like. I show me the number of times youdid this, but you know what was their coverall impression, yeah and so on theresults. I see that about forty six of your physicians. Forty six percentexcuse me had actually attempted the ea program, while really surprising thatonly fourteen per cent tried the right to try program or attempted yes, atleast as so i mean part of it is because expended ax has been there forso long. You know it's, therefore, literally dozens of years since time,eighty seven, whereas righters very you, i will say the right to pry- hasgarnered a lot of mediate attention you, while it was a belt and it was beingdiscussed on the floor of the congress and to the time that it was signed intolaw. There's been a lot of mediate attention on this, but you're right.Despite that, it was a little surprising that less than half of thephysicians had access for tried to uglie pep which isn't there, for youknow whatever forty years for thirty five years, and only fourteen person,like you said, had attempted to use the right to try, and do you think thatsome of it is attributed to right to try being just a kind of a newerprogram corrigan. It seemed that the success rates were slightly bigger, ofcourse, for expanded access. Since you had more more attempted than the rightto try that correct. Yes, you know remarkable success rates so for thosethat ve used titine access, almost ninety percent or eighty nine percentwere successful in gaining a e gaining access to the drug that they request us,and this is pretty impressive and with right, privas side nor it was someonelowered. Seventy two per cent, but still not not. You know something toignore it. Wasn't it's remarkable that three fourths of the time you'resuccessful and my you neither of these programs, neither the eap nor the rightto try mandate of the manufacturers to give out. You know the drug that'srequest on is completely up to the manufacturer whether they want to giveup give this drug order now. But you...

...know if you're getting access to a drug.Ninety percent of the time and that's a quicker market statistic in my mind, itseems remarkable to me. So what do you think are some barriers?Is it just a knowledge or is the? Are these programs can difficult to access?I think you'll write on both from so what our take a way was. So we had somequestions vary in our survey to assass. If the positions are able todistinguish between the two programs and only about a fourth of them, sotwenty seven percent of them correctly identify that for right to try you bypast the irb and you by past the fda. So so you know so the vast majorityactually didn't realize that that was a major difference. The other thing thatwe ask to assess you know to gauge their knowledge. An awareness was forthe expended access which requires fda sign off, i would say our fbvitvr. Youknow how. How often do you think f, p, a v signs offer, approves and expandedaccess request, and only three percent came up with the correct answer sobelieve it or not. The fda has approved ninety nine percent of the requests forexpanded access and an only thre perce hors plan, as actually you know, gaveus the right answer that over ninety five percent of the time you have deapproves that so, which again tells you that there's just lack of awareness andthen we also ask them. You know how often you know how many patients do youthink and minded this was only a year into right to try, because he sarystarted in the fall of two thousand and nineteen wheres the right to crylegislations passed in two thousand and eighteen. So we ask them. You know howmany patients do you think thus far have benefited from right to try andagain- and you know only by eleven percent- were able to guess the correctcancer. So there's definitely you know somelack of understanding and you brought up valuable terms in terms of eating itaugust, muddled, sometimes in people's hands. But also the process has beendaunting, t for expanded access and we ride fit moss its much simpler. Ohreally, so it's like so expanded access to require more support core then go right to try program, okay,e. What happen be, and you have your own irvin off now: do you knowfacilitate expanded access used and at the unition the f had actually made itmy singer in the past, ponto, wo thousand and fifteen. I believe youknow for expended access the entire hire be so the entire board have toapprove and expanded access request, but to simpli because a lot of timesyou know these requests are coming in in dire circumstances or you know when,unfortunately, a patient has limited time, perhaps so the fk modified thatguidance in said that expendin can be granted by one higher b member. So youknow if you are want to access...

...something virginly, even a one singleliar be member. I can authorize or prove in expanded actions request, butstill there's multiple staps. There's irb then going to the faft applicationas long i'll tell you. I've done it my stuff, but but you know the reistingthing is they do respond very quickly. The median timeto response, i think, is three to four days of the fda and, like i said theydo a prove majority. They have a true majority of the request. Of course youknow the physician like o o our listeners. You have to make sure thatyou know they are trying to do the right thing for the patient. You knowwe don't want to just throw something and see if it sticks, but if there'ssome sign of a rash now- and it makes sense- then it's definitely worthpursuing. So if i read how do i read i'm sorry? How do our listeners beginthe process? So, let's start with expanded access? What we would be thefirst step to take right so again, even for expanded access. You know because isuppose we have a patient who, unfortunately, is progressing throughavailable treatment options, but you know you and maybe there's an ongoingtinoco crowd, but if the patient may not qualify because of certain langconditions or they may just not be able to travel to the far off institution toparticipate in such and generally most colleges are aware of other agents orwhich are being attested in a given disease. Other ways they can useresources like clinical trials dog up that list all of the trials i'm goingin the duties, and so if you identify a drunk or you know that may potentiallybenefit your patient. Also, the patient has to be in reasonable condition, ifsomeone's very in very you know very frail or that what we say performstatus is very poor. You know they may not be the best candidate, because atthe end of the day we don't want to harm on the patient, but there are somepatients who are you know in reasonable performance status and some of them canbe good bust. So it's very simple. I would first start h with the making outreach the manufacturer and saying i have such a setain, and you know my. Ihave access who, under an expanded accent by the way, there's notlegislation that requires manufacturers to list on their website whether weoffer expanded access. You know program or not, and you know,by making an outreach to them, so they may say yes, if that is it that that'smy green light. I go to my ib with my case history and said: here's thecircumstance, here's the data for the drug. Would you approve this assumingthey approve that simultaneously, i would complete my whatever it is. Sixpage have the application and send that packet off with my ib approval, and youknow redacted patient history, and why it's a for weet for that patient. Iwould send that to the fda, expect a response within a week and then, withthat with those three things i will go to the manufacturer and, like i said,i've been through this myself several times and then you get your shipment.Of course. There still has to be informed consent for the patient,because you're giving them at an agent...

...that we don't know how they might reactto, but that's the job of the rb to make sure that you know a proper in fumconcern of in place. So and you know, then you start, and so that would be the eap program right to try, and youknow i sort of left full time practice by the time this legislation becamealso, i hely can not claim to have the first time experience with this, butagain here i think very often what i'm noticing is that it's more driven bythe patient, but the fisicas deal with themselves, because they have thephysician and even the fda garden says that the physician is the best personto decide. You know whether this drug may be beneficial or that you know somebenefits may outweigh harms, because it's not like every person has a rightto fly any drug or anything. So so you know the drug already should bepurposed, even though not approve. You know for their condition and like wewent over the criteria before and really the application on, the thewebsite is quite simple, but again the manufacturer cannot be mandated andagain my suggestion would be reach out or manufacture. First ask if they arewilling to share the drug. You know through it right to try mechanism. Ifthey deny, then it's not worth while going to the extra snaps and sometimesyou'll come across a manufacture. All say you know we cannot do right to try,but we can do expanded access. So so you know, then you might have to takethe longer pathway by you gus to have access to the agent okay. So for bothapproaches, you would go to the manufacturer first. I would. I thinkthat that way, yeah that that would streamline your affords and that way,you're not trying to you, know, walk on a path, that's going to lead to nowhere,and it sounds like right to try, especially because it's been kind ofrecent press and it's kind of a new new process. These are often patient,initiated requests very truly sous. So you will see a lotof stories and some of them, of course, very hard rending, but you know andbitas, and especially when there are children involved in such andespecially with rare diseases. I mean you know here we're talking aboutcanser, but then there are other diseases, there's muscular dystrophythere's you know spans to a tote, a kins of other and ological and otherconditions that predominatly affect children or even newborns, and you seea lot of stories you know of parents trying to make this kind of out reach.So everybody, yes, you know a lot of times. It is. I find the nation, thefamily sort of driving this, but then the physician and the team has tosupport them. Also guide them. You know what me to work. Man, i'd, beappropriate cool, of course. Of course the physician needs to be as deeplyinvolved in the process and the whole actually the whole carte really andthese decisions, so our cooloo office staff is very busy. Things are alwaysmoving, is always changing parts. How can they stay up to date on theseprocesses? What do you recommend...

...right? So i feel as though you know somebody easier for practicesand physicians and teams, and you know, offices which are already involved inresearch. I think that makes the process to lot simpler, because many ofthese stops your going for participation to take her coes anyway.Now with right to try. I don't believe that you can do that for every patientevery time, but they can be select circumstances where it makes a lot ofsense to try and pursue you know a treatment option a or a given patient.You know. Certainly i haven't forgotten my full time practice bay. Is i'm veryconscious ent of how you know the amount o clinical workload and work forresponsibilities that lie on the ecologist research team office staff?You know it the entire team and- and so this certainly would add, more work towhat they are trying to do, but i feel it's to the same order as it is toenroll a pation on a clinical faile, because you know, especially even thoseact activities, take a lot of time and afford. So i believe in my mind we dida work. That's in wild is about the same as enrolling episin on a cretintrial, so it's not a overwhelming it's a standard. Of course, if there were a lot ofpatients like that, it wotou, you know, that's why you have to pick and chooseyou know who the program i actually worked for and then another piece thatcame up in your research that i was curious about is: can these be requestsbe made for a small population of patience? So can we so i say i havethree or four patients in the same situation? Can i make one request forall of them and is that possible, for both programs, great person at least,is so possible. This is possible for the expanded access program, not forthe right to cry program. The right to try is an individual based programbased on individual need, but for expended access. Yes, it is possible toyou know, requested for a span group of ations. Do you have any say some anyhelpful tips for office staff as they are filling out this document any tipson how to communicate with patients while they're going through this pause,which i'm sure is very stressful, for all parties involved right? So you know,i think anyone in oncology- and you know everyone that touches a pationstarting from you- know the intake folks to the nurses, to the nuspar,ditions research coordinators and the back office folks. You know that maynot be meeting the patient, but it we have to be careful. I feel as thoughyou have to temper the patients and families expectations a lot of times.You know folks, men, unfortunately they're desperate or their losing hopethey tend to amplify. You know the possibility of success with anything,and so i think you know, while effort...

...is to be lot, we cannot obviously,first of all we can. I guarantee that you know a medication will becomeavailable number to even though it becomes available. It may not work andanother three not only may not at work. It may cause a serious side of that. Soso i think counselling, the patient love one family is so critical and ithink the massaging should be uniform across the team, because human natureis such that we always tend to believe the you know. One person who gave usthe most hope when they're down or when they're saying and what you do want todo- is that in this process of unfortunately, you know oncology careor fighting cancer s, a roller emotional roller coast to azadi. So youdon't want to get them too high and then let them fall too hard. So it wasokay to explain and say that we're going to try out this, but we don'tknow what the outcome is going to be so that you know there. That will be mysuggestion to the entire team so that again, if we gain access that's a goodday and then once you know, we'll have to be another good day after severalweeks to see that you know he medication working that it so to haveit an honest conversation and the temper you're. I mean your excitementof getting the possibility of a de treatment with the realistic outcome,so for someone who has gained access to a drug and have has had success so foreither of these program. How does that success affect the future use of thestrong? So does that expand the drugs used like permanentlyto that population? How does how does it affect the este roll out process of great points so release? So i thinkin this regard, the two protends are so different because, with the expandedaccess program, there's a more robust and back reporting, so you know they'rerecording in terms of outcomes in terms of what happens to any given patient iscaptured, much more assistant and much more consistently number one with theright to try. First of all, the program is very new, also understand who's. Thewatch dog, for you know all of drug therapy in this country, is the fda andwith the right to try program. What did we just say that you buy past me astill? So i think you know many have criticized the right crib program,saying that there wasn't enough oversight. You know, of course, thecounterpoint is that oversight, those things down, and sometimes thesepatients don't have that kind of time. So so i think both camps have valentarguments, but we have the legislation and the form that we have it, and sowith that, i think it's still an open question in terms of how the followersbeing managed. Currently there is no to the best of my knowledge, there isn't aconsistent way of capturing as to how many patients are benefiting from theright to cry program. However, i in my...

...reading, as a last year, the fda hasinstructed manes fractures to report to the f ba. You know how often are themeeting with the writer to fry utilization and in so so right now. What will happen is inany kind of outcomes, follow up that the those are laid down for right totry by the manufacturer. You know so what happened? What was the outcome?The manufacture capturing it, but there isn't doesn't seem to be a consistentway of them putting into large national database or what have you so soinformation somewhat fragmented, but i feel like that as much better organizedwith the eap program, because you know it's just been around longer and a lotof the bugs i've been working at worked out and also it has more oversight.Okay, so there's additional reporting, hopefully coming in the future- that wecan hopefully build off. Of that correct and there's been a lot ofrequests. Were you know by the fa for transparency that if the right try is agood thing and a manufactures are supporting it? Well then, let's getthat word out and you know put that out in an accessible area or database, sothat everyone knows what's going on and he'll earlier point about. You know ifthere is success that doesn't automatically that doesn'tautomatically obviously expand the label organ the approval, but you knowthe manufacturer does capture all of those real world examples as casereports and nk series which can help them. You know, as they are developingthe god for their or going to the fda for final approval. So in the case ofyou know, the patient that i mentioned at the beginning and i had obtained adrug called er latinum for them and that drug was in you know in adeveloping an i only had a number, not even a real name, but since that timeyou know it's been approved. A f we approved for that rare pon, al pasta oncancer and is now available for using public. So you know so there are, andeven the patient that i mentioned- they gain a lot of benefit from that.Ultimately, you know the cancer unfortunatelyprogressed, but you know they did it didn't help them by time. So all ofthose anecdote case reports case you just kind of get compiled together toindicate success. Aside from you know the work that's being on in a plan fortrial excellent, so there is some tracking to r gosha. This has been areally great conversation, so much in sight to it. Two processes that i thinkthat not everyone is has been exposed to one is actually it's pretty recent for any of our listeners who want toreach out to you with follow at questions or want to continue theconversation, what's the best way for them to do that sure yeah at least so.Thank you for having me but yeah folks. Anyone can reach me, i'm on a link inits age, gasa alien, the good thing about having a re name. Is there aren'ttoo many of me so by me easily also, i will post a urlthat as more at the cardinal level, but...

...we can certainly you can be in accessout through that route as well. But again i grealy appreciate theoportunity and for listeners here. Hopefully this has helped you someoneagain some confidence in terms of you know the two programs, because they aretalked about quite often so thank you for sharing your insights i'll, be sureto include lakes to your linked in and also your cardinal health website, inour show notes again, i appreciate you being a guest of the show today. Thank you robbing me. Are you satisfied with your patientscurd speed to therapy, or are you just settling? You can improve patientoutcomes? It bioplast pharmacies powers to the first ever two hours to day togather promise it's basto easier for you, interpatient learn more. Is abiopark you've been listening to working in oncollege to ensure that you never miss an episode inscribed to the show yourfavorite podcast player? If you're listening in at the podcast, we love,we in othe, show just have the number of stars you get the podcast to dirt.Thank you so much for listening until next time. I.

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