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Dr. Bob is Robert Hsiung, MD,
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Posted by dr. dave on August 22, 2002, at 10:35:50
In reply to First clinical experience with Lexapro, posted by dr. dave on August 22, 2002, at 5:23:48
OK, I've just found figures comparing side-effects for Celexa and Lexapro - they are from a promotional leaflet from Lundbeck and represent combined figures from four studies.
Ejaculation disorder is slightly more frequent with Lexapro than Celexa, as is insomnia, somnolence, upper respiratory tract infection and dizziness. Conversely headache, nausea, diarrhoea, dry mouth, influenza-like symptoms, rhinitis and sinusitis were slightly more common with Celexa than Lexapro.
All of these differenced do not seem to meet statistical significance.
Posted by Dinah on August 22, 2002, at 10:51:31
In reply to Allow me to rephrase . . . . » dr. dave, posted by Anyuser on August 22, 2002, at 10:01:06
I really appreciate the request for clarification and the apology and rephrasing.
That's the sort of thing that will make Dr. Bob's time away go much more smoothly.
So "Thanks for being civil" Dr. Dave and Anyuser. :)
Dinah
Posted by Anyuser on August 22, 2002, at 11:06:12
In reply to Sexual side-effects of Lexapro, posted by dr. dave on August 22, 2002, at 10:35:50
It is certainly true that what Lundbeck has to say on Cipralex.com is not very exciting, and not altogether consistent with the FDA-approved statements that Lexapro is effective at 10mg with s/e equivalent to placebo. I could not find the brochure you mentioned. For those poor souls who can't get enough of this topic, it is interesting to compare what's said on Lexapro.com and Cipralex.com. The differences must reflect what is allowed by the UK and US regulatory authorities. Also, no cartoons in the UK. Get with it, over there!
Posted by pharmrep on August 22, 2002, at 11:54:43
In reply to Cipralex » dr. dave, posted by Anyuser on August 22, 2002, at 11:06:12
> It is certainly true that what Lundbeck has to say on Cipralex.com is not very exciting, and not altogether consistent with the FDA-approved statements that Lexapro is effective at 10mg with s/e equivalent to placebo. I could not find the brochure you mentioned. For those poor souls who can't get enough of this topic, it is interesting to compare what's said on Lexapro.com and Cipralex.com. The differences must reflect what is allowed by the UK and US regulatory authorities. Also, no cartoons in the UK. Get with it, over there!
** It's not what the regulating agencies allowed or not...but that there are some different studies done at a later date that had some different results. Look at the "package insert" info for Lexapro to see the incidence of occurence and compare it to Celexa's. That is one way to compare....but remember Celexa was done over 5 years ago...and for example, sexual side effects was not as hot a topic as it is today...and all of the percentages were "volunteered," so Celexa at 6% was understated (more like 20%) and Lexapro at 9% (more accurate...maybe in the teens) does not necessarily denote an increase...in fact it is most likely a decrease.
Bottom line....only time (and doctor/patients experiences) will tell the true effectiveness of this new antidepressant. Will it be a miracle-drug...probably not...does it initially appear to work faster, with less side effects and less drug interactions compared to the rest of the AD's (including Celexa)? Yes. But it will take more time to prove itself. So since it is not even out in the US yet, and usage in the rest of the world is not enough to make a judgement yet...let's stop hypothesising and just wait and see. (We would all love to hear of any input DR Dave or anybody has as you get the opportunity to try it.)
Posted by Anyuser on August 22, 2002, at 12:48:14
In reply to Re: Cipralex/Lexapro » Anyuser, posted by pharmrep on August 22, 2002, at 11:54:43
What do you understand to be typical dosages for WB augmentation of Celexa?
Posted by pharmrep on August 22, 2002, at 15:33:19
In reply to Question re cel-wel » pharmrep, posted by Anyuser on August 22, 2002, at 12:48:14
> What do you understand to be typical dosages for WB augmentation of Celexa?
* I have heard different ideas from multiple Dr's. The Celexa side doesnt matter since 20-60mg is tolerable for most patients. The Wellbutrin in where they differ...50-150 is the range...most of the concern is if patients are prone to seizures...Wellbutrin could be a prob.
Posted by Anyuser on August 22, 2002, at 16:43:50
In reply to Re: Question re cel-wel » Anyuser, posted by pharmrep on August 22, 2002, at 15:33:19
What do you understand to be the typical dose of Celexa? How often is 20mg prescribed? Do you know if pdocs typically prescribe a lower dose for maintenance, less than the therapeutic dose?
Does Forest have any expectation that some pdocs, presumably those that prescribe lower doses of Celexa, will prescribe 5mgs of Lexapro?
Thanks for your help. I am interested in your view of what practitioners do with your product. If you don't know the answers, that's fine.
Posted by pharmrep on August 22, 2002, at 17:26:50
In reply to More dosage questions » pharmrep, posted by Anyuser on August 22, 2002, at 16:43:50
> What do you understand to be the typical dose of Celexa? How often is 20mg prescribed? Do you know if pdocs typically prescribe a lower dose for maintenance, less than the therapeutic dose?
>
> Does Forest have any expectation that some pdocs, presumably those that prescribe lower doses of Celexa, will prescribe 5mgs of Lexapro?
>
> Thanks for your help. I am interested in your view of what practitioners do with your product. If you don't know the answers, that's fine.** Celexa rx's are as follows; 10mg-20mg=63% 30mg-40mg=32% 40mg+=5%. In my experience..General practitioners and Internists will use 20-40mg but refer out to psychs if not helping. My psychs are not afraid to go higher at all...20-40 is routine..i have many who write 60-80 (there are a few studies that show 80mg without probs) I even have a few that have gone to 100+.
As for Lexapro..the indications are pretty clear, and dosing is easy...10mg for everybody as the starting and maintenace dose...they are scored if you want to go to 15 or a 20 mg tab is available. As for 5mg...no studies yet, probably wont be since 10mg appears to be close to 40mg of Celexa. Since so many other AD's have a "titration" regimen...10 and 20 might seem too easy.(and only 1 wk needed before titrating if needed). Remember, the studies showed 1-2 wks for most patients and efficacy will be seen. Some Dr's might try 5mg to start, but the efficacy probably wont be the same since all the studies were done at 10 and 20mg
Posted by Anyuser on August 22, 2002, at 17:39:26
In reply to Re: dosage » Anyuser, posted by pharmrep on August 22, 2002, at 17:26:50
What's curious to me is that nearly 2/3 of practitioners prescribe 20mg Celexa or less, and we're told that 10mg Lexapro=40mg Celexa, yet there seems to be no expectation that any practitioner would prescribe less than 10mg Lexapro.
Oh well. Time will tell. Thanks for your answers.
Posted by moxy1000 on August 22, 2002, at 19:04:13
In reply to Re: First clinical experience with Lexapro, posted by Bill L on August 22, 2002, at 10:30:09
I have done thorough research on Lexapro and am impressed so far by the clinical data. Nine positive studies and zero negative studies (for example, studies where Lexapro didn't work) were submitted to the FDA. That is a record for any new drug application. As far as it being a "miracle drug" - probably not. It's not really based on cutting edge technology, but based on clinical data alone, it looks like it will work more efficiently then anything else available on the market today. (Ane when I say efficient, I mean it will work more quickly and w/ fewer side effects.) The side effect profile of this drug looks like that of a vitamin. And you can apparently take it w/o any real risk of drug interactions, so that's good if you're taking several different meds. Plus, I understand from one of my friends at Walgreen's, it is priced less then any branded SSRI (including Celexa). In short, when you consider the withdrawal complaints from paxil and effexor, the weight gain complaints from paxil and remeron, the black box warning that serzone has, the nausea caused by zoloft, the drug interactions caused by prozac, and the significant seizure risk associated with wellbutrin, Lexapro looks pretty good. No drug is perfect for everybody, but this looks like it will be worth a shot.
Just my two cents.
Posted by pharmrep on August 22, 2002, at 20:20:05
In reply to Re: dosage » pharmrep, posted by Anyuser on August 22, 2002, at 17:39:26
> What's curious to me is that nearly 2/3 of practitioners prescribe 20mg Celexa or less, and we're told that 10mg Lexapro=40mg Celexa, yet there seems to be no expectation that any practitioner would prescribe less than 10mg Lexapro.
>
> Oh well. Time will tell. Thanks for your answers.*** Remember...in the studies, it was found that the r-citalopram is actually inhibiting the s-citalopram from working to its fullest capability. (Did you see the Sanchez microdialysis study?) That is why it doesnt take as much s-citalopram (Lexapro) to be as/or more effective than 40mg of Celexa. It's all about effectiveness and tolerability
Posted by pharmrep on August 22, 2002, at 20:25:46
In reply to Lexapro clinical data, posted by moxy1000 on August 22, 2002, at 19:04:13
> I have done thorough research on Lexapro and am impressed so far by the clinical data. Nine positive studies and zero negative studies (for example, studies where Lexapro didn't work) were submitted to the FDA. That is a record for any new drug application. As far as it being a "miracle drug" - probably not. It's not really based on cutting edge technology, but based on clinical data alone, it looks like it will work more efficiently then anything else available on the market today. (Ane when I say efficient, I mean it will work more quickly and w/ fewer side effects.) The side effect profile of this drug looks like that of a vitamin. And you can apparently take it w/o any real risk of drug interactions, so that's good if you're taking several different meds. Plus, I understand from one of my friends at Walgreen's, it is priced less then any branded SSRI (including Celexa). In short, when you consider the withdrawal complaints from paxil and effexor, the weight gain complaints from paxil and remeron, the black box warning that serzone has, the nausea caused by zoloft, the drug interactions caused by prozac, and the significant seizure risk associated with wellbutrin, Lexapro looks pretty good. No drug is perfect for everybody, but this looks like it will be worth a shot.
>
> Just my two cents.** Hi there...do you have access to the studies online? I only have hard copies and cant find links to share here...can you help?
Posted by Anyuser on August 22, 2002, at 21:40:58
In reply to Re: dosage » Anyuser, posted by pharmrep on August 22, 2002, at 20:20:05
I get it that 10mg of Lexapro is supposed to be equivalent to 40mg Celexa. However, two thirds of practitioners prescribe less than 40mg Celexa. If you buy the 10=40 equivalence, there is a sizeable difference between the potency of Lexapro that Forest recommends and apparently expects to be prescribed and the potency of Celexa that 2/3 of doctors prescribe today.
Posted by pharmrep on August 22, 2002, at 22:50:59
In reply to The point » pharmrep, posted by Anyuser on August 22, 2002, at 21:40:58
> I get it that 10mg of Lexapro is supposed to be equivalent to 40mg Celexa. However, two thirds of practitioners prescribe less than 40mg Celexa. If you buy the 10=40 equivalence, there is a sizeable difference between the potency of Lexapro that Forest recommends and apparently expects to be prescribed and the potency of Celexa that 2/3 of doctors prescribe today.
** good observation. Although indicated from 20-60mg...Celexa did not get used by the majority of internist/general practitioners beyond 40mg. Why...we arent sure...mostly it seems that without specific training...most family practices dont want to take "unknown risks" so they would not want to go too high in their mind. This group of doctors represents the largest segment of prescribers. Psychs ,although willing to titrate higher and having the training to observe more properly...represent a smaller percentage of prescribing doctors. Since effacacy and tolerability are seen earlier at a higher dose, that is why 10mg is used. This will probably result in many more patients being treated at the general practice level, and not necessarily being referred to psychs as often (assuming the patient is seeing the desired results.)
This is mine and the opinions of others at our meetings...no official Forest statement...if I get one, I will let you know.
Posted by Ritch on August 22, 2002, at 23:27:51
In reply to Re: dosage » Anyuser, posted by pharmrep on August 22, 2002, at 17:26:50
> > What do you understand to be the typical dose of Celexa? How often is 20mg prescribed? Do you know if pdocs typically prescribe a lower dose for maintenance, less than the therapeutic dose?
> >
> > Does Forest have any expectation that some pdocs, presumably those that prescribe lower doses of Celexa, will prescribe 5mgs of Lexapro?
> >
> > Thanks for your help. I am interested in your view of what practitioners do with your product. If you don't know the answers, that's fine.
>
> ** Celexa rx's are as follows; 10mg-20mg=63% 30mg-40mg=32% 40mg+=5%. In my experience..General practitioners and Internists will use 20-40mg but refer out to psychs if not helping. My psychs are not afraid to go higher at all...20-40 is routine..i have many who write 60-80 (there are a few studies that show 80mg without probs) I even have a few that have gone to 100+.
> As for Lexapro..the indications are pretty clear, and dosing is easy...10mg for everybody as the starting and maintenace dose...they are scored if you want to go to 15 or a 20 mg tab is available. As for 5mg...no studies yet, probably wont be since 10mg appears to be close to 40mg of Celexa. Since so many other AD's have a "titration" regimen...10 and 20 might seem too easy.(and only 1 wk needed before titrating if needed). Remember, the studies showed 1-2 wks for most patients and efficacy will be seen. Some Dr's might try 5mg to start, but the efficacy probably wont be the same since all the studies were done at 10 and 20mgPharmRep,
Why can't most SSRI manufacturer's go for the very low-dose maintenace dosages with scored tablets instead of liquids? I realize that it probably is far cheaper to "tool" for a liquid version, than to create dies and whatnot for low-dose tablets (and add scoring to the costs). However, given that you mention that about 2/3 of the prescribers are on the low-dose end, why not market very low-dose tablet alternatives? With Celexa, the max. I can tolerate every day is nowhere near 10mg. A 5mg tablet of Lexapro that is scored FOUR-WAYS to enable one to take a quarter-tablet would be a fine marketing idea, HINT-HINT
Mitch
Posted by pharmrep on August 23, 2002, at 0:05:14
In reply to Re: dosage » pharmrep, posted by Ritch on August 22, 2002, at 23:27:51
> > > What do you understand to be the typical dose of Celexa? How often is 20mg prescribed? Do you know if pdocs typically prescribe a lower dose for maintenance, less than the therapeutic dose?
> > >
> > > Does Forest have any expectation that some pdocs, presumably those that prescribe lower doses of Celexa, will prescribe 5mgs of Lexapro?
> > >
> > > Thanks for your help. I am interested in your view of what practitioners do with your product. If you don't know the answers, that's fine.
> >
> > ** Celexa rx's are as follows; 10mg-20mg=63% 30mg-40mg=32% 40mg+=5%. In my experience..General practitioners and Internists will use 20-40mg but refer out to psychs if not helping. My psychs are not afraid to go higher at all...20-40 is routine..i have many who write 60-80 (there are a few studies that show 80mg without probs) I even have a few that have gone to 100+.
> > As for Lexapro..the indications are pretty clear, and dosing is easy...10mg for everybody as the starting and maintenace dose...they are scored if you want to go to 15 or a 20 mg tab is available. As for 5mg...no studies yet, probably wont be since 10mg appears to be close to 40mg of Celexa. Since so many other AD's have a "titration" regimen...10 and 20 might seem too easy.(and only 1 wk needed before titrating if needed). Remember, the studies showed 1-2 wks for most patients and efficacy will be seen. Some Dr's might try 5mg to start, but the efficacy probably wont be the same since all the studies were done at 10 and 20mg
>
>
>
> PharmRep,
>
> Why can't most SSRI manufacturer's go for the very low-dose maintenace dosages with scored tablets instead of liquids? I realize that it probably is far cheaper to "tool" for a liquid version, than to create dies and whatnot for low-dose tablets (and add scoring to the costs). However, given that you mention that about 2/3 of the prescribers are on the low-dose end, why not market very low-dose tablet alternatives? With Celexa, the max. I can tolerate every day is nowhere near 10mg. A 5mg tablet of Lexapro that is scored FOUR-WAYS to enable one to take a quarter-tablet would be a fine marketing idea, HINT-HINT
>
> Mitch
>
** I think it boils down to this...efficacy just isnt seen at lower doses, and the "majority" of patients see the right amount of effectiveness at the starting doses. In your case, you just happen to be more sensitive and only lower doses are tolerable...unfortunately...you are in the minority. One other thought...have you considered that when you "cut" your own tabs, that since the active ingredients are so trace that you may not be getting a "therapeutic" dose? I know that the scored tablets are ok, but any further splitting might be giving you a placebo sometimes. (I dont know this for fact with Celexa...I am just theorizing with you since all manufacturing is done differently.)
Posted by dr. dave on August 23, 2002, at 3:59:39
In reply to Re: Lexapro clinical data » moxy1000, posted by pharmrep on August 22, 2002, at 20:25:46
The chief study on Lexapro v. Celexa is that by Gorman, and is a meta-analysis of three 8-week studies comparing Lexapro, Celexa and placebo. It is available in poster form at
http://www.cipralex.ch/pdf/poster/gorm521_501.pdf
and in its full form at
http://www.cipralex.ch/pdf/literatur/gorman.pdfHave a look at the end-point results when drop-outs have been taken into account - on the poster Cipralex is more effective than Lexapro by a tiny amount, in the printed paper it's the other way round. Same study, same graph. Go figure, as I understand you say on your side of the Atlantic.
There are also papers galore at
http://www.cipralex.ch/f/poster.htmlIt gets a bit overwhelming but here's what research there is
- lots of preclinical studies
- three 8-week studies comparing Celexa, Lexapro and placebo only two of which are available (Burke et al and Lepola et al, despite me having asked Lundbeck specifically for the third)
- a meta-analysis of these three (Gorman)
- a study comparing Lexapro and placebo alone
- a longer term study which again does not seem to be available for scrutinyAll of these papers have been produced by Lundbeck/Forest. You may think that as they are 'scientific papers' they could not be biased or misleading. You may think otherwise.
It is worth noting studies which show that research on the same topics published by those with conflicts of interest consistently come to different conclusions than those published by independent authors (British Medical Journal - I don't have the reference to hand but will supply it later)
Posted by dr. dave on August 23, 2002, at 8:21:18
In reply to Re: Lexapro clinical data » pharmrep, posted by dr. dave on August 23, 2002, at 3:59:39
Here's the link for the BMJ article about conflict of interest affecting trial results I referred to.
Posted by Ritch on August 23, 2002, at 8:34:52
In reply to Re: scoring » Ritch, posted by pharmrep on August 23, 2002, at 0:05:14
> > PharmRep,
> >
> > Why can't most SSRI manufacturer's go for the very low-dose maintenace dosages with scored tablets instead of liquids? I realize that it probably is far cheaper to "tool" for a liquid version, than to create dies and whatnot for low-dose tablets (and add scoring to the costs). However, given that you mention that about 2/3 of the prescribers are on the low-dose end, why not market very low-dose tablet alternatives? With Celexa, the max. I can tolerate every day is nowhere near 10mg. A 5mg tablet of Lexapro that is scored FOUR-WAYS to enable one to take a quarter-tablet would be a fine marketing idea, HINT-HINT
> >
> > Mitch
> >
> ** I think it boils down to this...efficacy just isnt seen at lower doses, and the "majority" of patients see the right amount of effectiveness at the starting doses. In your case, you just happen to be more sensitive and only lower doses are tolerable...unfortunately...you are in the minority. One other thought...have you considered that when you "cut" your own tabs, that since the active ingredients are so trace that you may not be getting a "therapeutic" dose? I know that the scored tablets are ok, but any further splitting might be giving you a placebo sometimes. (I dont know this for fact with Celexa...I am just theorizing with you since all manufacturing is done differently.)
I take a low-dose SSRI primarily to help prevent panic attacks and several of them (including Celexa) work rather well for that. It seems that with SSRI's I only need that small amount to make a big difference. Also, at higher doses they (all of them) tend to precipitate hypomania (I am bipolar). That is primarily the "sensitivity" issue. I had a general practictioner who disbelieved strongly that it wasn't doing me any good to take such a small amount, so "why take any at all". That was before a study was done that showed people could take as little as 15mg of Prozac every week as a *maintenance* to prevent panic. Then Prozac weekly came out after that (but not specifically for that condition). I wonder how many people out there on *maintenance* regimes for panic would find the four-way scored 5mg Lexapro tabs very convenient. The data you provide about dosages probably relate to "acute" treatment for depression only (which is the only formal indication for Celexa and Lexapro thus far-here in the US anyhow). There are many people who are being treated for anxiety disorders with SSRI's as well.thanks,
Mitch
Posted by Anyuser on August 23, 2002, at 8:53:10
In reply to Re: Lexapro clinical data, posted by dr. dave on August 23, 2002, at 8:21:18
Your comments are reasonable and interesting and apparently bona fide, but I have to ask. Do you have any biases or conflicts we should know about? What animates you to build a case against escitalopram?
Posted by pharmrep on August 23, 2002, at 9:39:16
In reply to Re: scoring » pharmrep, posted by Ritch on August 23, 2002, at 8:34:52
> > > PharmRep,
> > >
> > > Why can't most SSRI manufacturer's go for the very low-dose maintenace dosages with scored tablets instead of liquids? I realize that it probably is far cheaper to "tool" for a liquid version, than to create dies and whatnot for low-dose tablets (and add scoring to the costs). However, given that you mention that about 2/3 of the prescribers are on the low-dose end, why not market very low-dose tablet alternatives? With Celexa, the max. I can tolerate every day is nowhere near 10mg. A 5mg tablet of Lexapro that is scored FOUR-WAYS to enable one to take a quarter-tablet would be a fine marketing idea, HINT-HINT
> > >
> > > Mitch
> > >
> > ** I think it boils down to this...efficacy just isnt seen at lower doses, and the "majority" of patients see the right amount of effectiveness at the starting doses. In your case, you just happen to be more sensitive and only lower doses are tolerable...unfortunately...you are in the minority. One other thought...have you considered that when you "cut" your own tabs, that since the active ingredients are so trace that you may not be getting a "therapeutic" dose? I know that the scored tablets are ok, but any further splitting might be giving you a placebo sometimes. (I dont know this for fact with Celexa...I am just theorizing with you since all manufacturing is done differently.)
>
>
> I take a low-dose SSRI primarily to help prevent panic attacks and several of them (including Celexa) work rather well for that. It seems that with SSRI's I only need that small amount to make a big difference. Also, at higher doses they (all of them) tend to precipitate hypomania (I am bipolar). That is primarily the "sensitivity" issue. I had a general practictioner who disbelieved strongly that it wasn't doing me any good to take such a small amount, so "why take any at all". That was before a study was done that showed people could take as little as 15mg of Prozac every week as a *maintenance* to prevent panic. Then Prozac weekly came out after that (but not specifically for that condition). I wonder how many people out there on *maintenance* regimes for panic would find the four-way scored 5mg Lexapro tabs very convenient. The data you provide about dosages probably relate to "acute" treatment for depression only (which is the only formal indication for Celexa and Lexapro thus far-here in the US anyhow). There are many people who are being treated for anxiety disorders with SSRI's as well.
>
> thanks,
>
> Mitch
>
>** I am fascinated to hear that such a low dose (of any med) can still work for somebody in an off label application. I know that panic attack studies (for the indication) are being done. It will be interesting to see what mg is recommended.
PS You didnt comment on the "scoring" theory.
Posted by moxy1000 on August 23, 2002, at 11:09:37
In reply to Re: Lexapro clinical data » moxy1000, posted by pharmrep on August 22, 2002, at 20:25:46
Dr. Dave - I totally agree and understand that there seems to be some kind of "bias" on behalf of drug company data. However, there wouldn't be much data at all if not for the funds made available by drug companies in way of unrestricted educational grants. My suggestion to you would be this - if you don't "trust" the drug companies, do your own "clinical study" on Lexapro. Your experience with the drug, after all, will be the only experience that matters.
Just my two cents.
Posted by moxy1000 on August 23, 2002, at 11:17:03
In reply to Bias » dr. dave, posted by Anyuser on August 23, 2002, at 8:53:10
Never thought of it that way, but that is a good question. I will anxiously await Dr. Dave's response. Perhaps he is paid by other drug companies as a lecturer or research clinician? Maybe a lot of stock in a competitors company? It does seem he has a vested interest in tarnishing this drugs reputation, and since I'll presume Dr. Dave hasn't had wide clinical experience with Lexapro, I'm curious as to why he already has disdain for it.
Posted by moxy1000 on August 23, 2002, at 11:19:54
In reply to Re: Sanchez study » IsoM, posted by pharmrep on August 21, 2002, at 22:57:22
I heard about the sanchez study but it was my understanding that it wasn't finished yet (at least it wasn't back in June.) Maybe they're still getting the data ready for submission?
Posted by moxy1000 on August 23, 2002, at 11:21:40
In reply to Re: Lexapro clinical data » moxy1000, posted by pharmrep on August 22, 2002, at 20:25:46
I haven't found the studies on line, either, but they will be widely available in hard copy form sometime in september.
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