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November 18, 2016 - Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that it has completed patient enrollment for its Phase 3 LEVO-CTS trial in cardiac surgery.
The Company will lock its database after 30-day follow-up from the final patient, and currently expects to report top-line results in January 2017 in conjunction with the study’s lead investigators at Duke Clinical Research Institute (DCRI).
“We are very pleased to reach this milestone after more than two years of hard work, and would like to thank all of the patients and investigators who have taken part in the trial,” said John Kelley, CEO of Tenax Therapeutics. “Consistent clinical execution and increased trial visibility has significantly accelerated the enrollment rate during these past 12 months, and we believe the expanded number of patients ensures that we have the best possible chance for success. We now look forward to sharing top-line results with you during the next few months, and we are prepared for a near-term NDA submission and commercial effort if the data reads out positively. We continue to believe that levosimendan has the potential to fill an important void in the current treatment paradigm for cardiac surgery.”
this price movement is not really promising. Days before top line data supposed to be communicated, we experience heavy selling pressure - looks like insider trading to me ... hope the sellers are wrong, just for once - after 8 years of suffering - any opinion?
180 to go ! count down has started ! enrollment pace constant at 60 plus per month!
580 enrolled !
and yes 99% down form its high - we are living in the present and not in the past, at todays share price level TENX is definitely worth a gamble and todays management is not the same as 8 years ago.
The chance to x-fold the investment is much greater than 8 years ago...
the past is history-the future a mystery-but today is a gift, that's why they call it "the present".
Phase 3 enrollment will be most likely completed in Q3-2016, if not even earlier.
FDA fast track status- sufficient funds AVAILABLE, results will be the decision maker - not anyone else on this board... good luck to all longs and even greater luck to all shorts, they will need it at current share price, GLTA and laughing is good for your health!
200 to go
as of April 20, 2016 - 560 patients enrolled , phase 3, source: www.tenaxthera.com
enrollment pace looks steady at 60 patients on a monthly basis -
Phase 3 with 760 patients could be completed by end of July 2016!
502 enrolled ! , phase 3 enrollment will be most likely completed in Q3, 2016, FDA fast track status- sufficient funds available, results will be the decision maker - not anyone else on this board...
Is it possible that you have missed all the explaining posts to this subject? Same old same old. We are in year 2016 not in year 2000, technologies, demands, indications and situations might have changed in certain worlds, possibly not in yours. TENX has two strong indications with a huge unmet demand and no product out there which is doing better. I refer to the beta-study, which you also might have missed. never mind, you believe what you believe, nobody wants and can change your opinion, it is what it is. I believe in the potential of this product and company based on facts and ongoing studies with FDA fast track status and Cleveland University as a main enrolling hospital for this trial.
But thank you for your unconditional, constant reminder of this fraud and your stamina for reminding all that this is nothing more than smoke and mirrors.
- good enrollment update, 463 patients already 50-60 patients per month in Jan and Feb !
- trial is on track, enrollment for phase 3 completed possibly earlier than anticipated
- sufficient funds
- septic shock on the move
- 50% data read out potentially in Q2, 2016, 70% data read out potentially in Q3, 2016
- clear strategy, unmet need and good market potential
but stock under constant selling pressure ?!
It will be interesting to see after the reporting period if and which fund had to sell its position due to closure by end of Dec 2015, this is the only reasonable explanation why this stock is not much higher as of now.
to a bright future of TENX
check out the recent presentation of TENX on their web-site
- good enrollment update, 463 patients already 50-60 patients per month in Jan and Feb !
- trial is on track, enrollment for phase 3 completed possibly earlier than anticipated
- sufficient funds
- septic shock on the move
- 50% data read out potentially in Q2, 2016, 70% data read out potentially in Q3, 2016
- clear strategy, unmet need and good market potential
but stock under constant selling pressure ?!
It will be interesting to see after the reporting period if and which fund had to sell its position due to closure by end of Dec 2015, this is the only reasonable explanation why this stock is not much higher as of now.
to a bright future of TENX
check out the recent presentation of TENX on their web-site
- good enrollment update, 463 patients already 50-60 patients per month in Jan and Feb !
- trial is on track, enrollment for phase 3 completed possibly earlier than anticipated
- sufficient funds
- septic shock on the move
- 50% data read out potentially in Q2, 2016, 70% data read out potentially in Q3, 2016
- clear strategy, unmet need and good market potential
but stock under constant selling pressure ?!
It will be interesting to see after the reporting period if and which fund had to sell its position due to closure by end of Dec 2015, this is the only reasonable explanation why this stock is not much higher as of now.
to a bright future of TENX
check out the recent presentation of TENX on their web-site
funds holding TENX
https://www.holdingschannel.com/bystock/?symbol=tenx
450 patients enrolled - phase 3 enrollment should be finished end of Q3 -'16. all is looking good from the medical side.
Completely different story in regards to stock price!
I hope I am completely wrong but the stock price looks like being manipulated and due to its history there are not enough buyers left to keep the price at its level despite the huge potential.
Sufficient funds to complete phase 3 trial with FDA fast track status - completed phase 2 study in the UK in regards to septic shock - and the stock price is going down almost every single session ?!
There are rumors ad speculations that a group is very interested in driving this stock down, pick it up and go private ! nice plan but hopefully - if so - that scammed share holders will sue those who cause this scandal...and what more is needed that finally SEC is checking this stocks activities?
LEVO-CTS 408 patients enrolled as of Feb 8,2016 - 20 patients in 8 days enrolled and enrollment speed accelerating! With the assumption that 60 per month will be enrolled, phase 3 LEVO-CTS study, with FDA fast track approval, will be finished at the end of September 2016, with a potential data read out in Q1, 2017 and immediate approval. Probability of approval by the FDA is very very high, as this drug is accepted in over 50 countries world wide already !
buckle up shorties , here comes the ride !
LEVO-CTS 388 patients enrolled, 63 only in January - good momentum of enrollment will continue.
DSMB approved the continuation of the trial without any changes to be applied, good sign.
Short data: 889'500 shorts
http://shortsqueeze.com/?symbol=tenx&submit=Short+Quote%99
phase 3- enrollment LEVO-CTS is moving
http://www.tenaxthera.com/
as of January 26, 2016 - 380 patients enrolled, speed is picking up
In my opinion the volume is not big enough to be considered a sell-off.
It might be more likely that shorts try to take advantage of the technical sell indicator as it hit a new 52 weeks low. Some long term holders might give in as the company has a delay with patient enrollment which was forecasted to be finish much earlier than the end of 2016, the new low might also be the trigger that new longs are getting out again. For me it is worth the gamble and sit it out as the company has still 40 million dollars in cash, which will last until end of 2017. Read out of UK septic shock data is expected for first half 2016, which might be a good trigger for a positive stock movement as this indication (septic shock) is not in any way taken in the valuation of the company as of now. The phase 3 trial is enrolling ok-ish and could be finished in Q4 2016, so 2016 is a boom or blast year for this company - either the stock will be zero or much much higher than today. I think it is worth sitting it out especially when your cost price is much higher than todays market price. the probability that results will be good is very high as the product is already approved in over 50 countries world wide.. stay calm and believe
short interest : 913'600 shares
http://shortsqueeze.com/?symbol=tenx&submit=Short+Quote%99
latest update on TENX, and all is well.
http://finance.yahoo.com/news/tenx-enrollment-picks-phase-3-205000419.html
btw: phase 2b in UK, septic shock, all 516 patients enrolled, well done! http://leopards-trial.org/
latest analyst report about TENX - share price undervalued - read below...
http://finance.yahoo.com/news/tenx-fda-approves-phase-3-200000328.html
just a thought?
Levosimendan in the UK will achieve its goal and results will be very strong (and it is used in so many hospitals in Europe already in LCOS successfully) but for TENX this will mean most likely a phase 3 approval from FDA for septic shock, - double edged sword - which (referring to a phase 3 trial in the US for septic shock) will cost a little fortune ! TENX will need to raise capital for that and this might clash with the potential of the stock price for TENX, it might be limited for the mid term but as said, just a thought - anyone?
Zacks Small Cap Research has initiated coverage of Tenax Therapeutics, Inc.
See below for access to the 24-page report on the company.
http://finance.yahoo.com/news/tenx-initiating-coverage-tenax-therapeutics-151000561.html
Absolute shocking news ! the bleeding continuous!
Based on what should they get a base salary and bonus increase ?
I am really puzzled as those guys are the best paid in the industry for having achieved nothing material yet, halleluja, greed rules !
On June 17, 2015, William Chatfield, a director of Tenax Therapeutics, Inc. (the “Company”) advised the Company that he will not stand for re-election when his term expires at the annual meeting of stockholders to be held in September 2015 and will serve as a director until that time.
Additionally, on June 18, 2015, the Company entered into an amendment to the employment agreement of each of John Kelley, the Company’s Chief Executive Officer, and Michael Jebsen, the Company’s Chief Financial Officer.
The amendment to Mr. Kelley’s employment agreement increases his base salary to $430,000 from $330,000, effective as of May 1, 2015, and also increases his target annual cash bonus to 75% of his base salary, based on 100% achievement of annual goals (with no cap on the bonus for greater than 100% achievement of goals). The amendment to Mr. Jebsen’s employment agreement increases his base salary to $325,000 from $285,000, effective as of May 1, 2015, while removing the fixed monthly automobile allowance of $800.
The amendments described above are filed as Exhibits 10.1 and 10.2 to this Current Report on Form 8-K. The foregoing summaries of the terms of these documents are subject to, and qualified in their entirety by, such documents, which are incorporated herein by reference.
"This Analyst Day showcased the highly-regarded physicians and scientists who have significant experience with levosimendan in several indications,” said John Kelley, CEO of Tenax Therapeutics. “The substantial body of clinical experience continues to give us confidence in a positive readout for our LEVO-CTS trial in early 2016. We also eagerly await results from the LeoPARDS trial with our colleagues at Imperial College London to assess whether levosimendan can provide a significant clinical benefit in septic shock, and we plan to provide a statistical analysis plan for that trial to the FDA in the second half of calendar 2015 for evaluation with regard to how the data might support a regulatory filing.”
An archived replay of the audio webcast for the event with presentation slides can be accessed under “Events and Presentations” in the Investors section of the Company’s website at www.tenaxthera.com.
Enrollment Progress Update for LEVO-CTS and LeoPARDS Trials
Today, Tenax also provided an enrollment update for its ongoing Phase 3 LEVO-CTS trial in LCOS. As of April 15, 2015, the Company had activated 44 clinical sites and enrolled 58 patients. This compares to 40 sites activated and 41 patients enrolled based on the last update provided on March 18, 2015.
In August 2014, Tenax entered into a strategic collaboration with Imperial College London to provide supplemental funding for the ongoing LeoPARDS trial being conducted for levosimendan in septic shock in the United Kingdom. As of today, the trial has enrolled 283 out of an estimated 516 patients (www.leopards-trial.org).
Sepsis is a life-threatening condition that causes the blood pressure to fall dangerously, compromising blood flow to vital organs such as the liver and kidney. It is the leading cause for admission to an intensive care unit in the UK, accounting for about 30% of all admissions. Despite advances in treatment around 40% of such patients unfortunately die.
Conventionally, adrenaline-like drugs are used to support a patient’s blood pressure but they can have serious side effects. Levosimendan is a new type of drug that is currently used to treat patients with advanced heart failure. It works in a different manner to adrenaline-like drugs, potentially avoiding some of these side effects. It may also improve the blood flow to vital organs. In small scale clinical trials in patients with sepsis who have been given levosimendan significant improvements were seen in the function of the heart, kidneys and other organs.
Septic shock is a medical condition as a result of severe infection and sepsis, though the microbe may be systemic or localized to a particular site.[1] It can cause multiple organ dysfunction syndrome (formerly known as multiple organ failure) and death.[1] Its most common victims are children, immunocompromised individuals, and the elderly, as their immune systems cannot deal with the infection as effectively as those of healthy adults. Frequently, patients suffering from septic shock are cared for in intensive care units. The mortality rate from septic shock is approximately 25–50%.[1]
273 patients enrolled, over 50% reached! - septic shock- updated number of Leopards-trail UK
www.leopards-trial.org
CONCLUSION: meta-anayisis - LEVO-CTS
Levosimendan seems to be the most efficacious inodilator to improve survival in cardiac surgery.
and there is the potential of (see below)...why would TENX have paid $500'000 to get access to the trial data in the UK ?!
Sepsis is a life-threatening condition that causes the blood pressure to fall dangerously, compromising blood flow to vital organs such as the liver and kidney. It is the leading cause for admission to an intensive care unit in the UK, accounting for about 30% of all admissions. Despite advances in treatment around 40% of such patients unfortunately die.
Conventionally, adrenaline-like drugs are used to support a patient’s blood pressure but they can have serious side effects. Levosimendan is a new type of drug that is currently used to treat patients with advanced heart failure. It works in a different manner to adrenaline-like drugs, potentially avoiding some of these side effects. It may also improve the blood flow to vital organs. In small scale clinical trials in patients with sepsis who have been given levosimendan significant improvements were seen in the function of the heart, kidneys and other organs.
Septic shock is a medical condition as a result of severe infection and sepsis, though the microbe may be systemic or localized to a particular site.[1] It can cause multiple organ dysfunction syndrome (formerly known as multiple organ failure) and death.[1] Its most common victims are children, immunocompromised individuals, and the elderly, as their immune systems cannot deal with the infection as effectively as those of healthy adults. Frequently, patients suffering from septic shock are cared for in intensive care units. The mortality rate from septic shock is approximately 25–50%.[1]
A Bayesian network meta-analysis on the effect of inodilatory agents on mortality.
Greco T1, Calabrò MG1, Covello RD1, Greco M1, Pasin L1, Morelli A2, Landoni G3, Zangrillo A1.
Author information
April 13 will be interesting!
Abstract
BACKGROUND:
Inodilators are commonly used in critically ill patients, but their effect on survival has not been properly studied to date. The objective of this work was to conduct a network meta-analysis on the effects of inodilators on survival in adult cardiac surgery patients, and to compare and rank drugs that have not been adequately compared in head-to-head trials.
METHODS:
Relevant studies were independently searched in BioMedCentral, MEDLINE/PubMed, Embase, and the Cochrane Central Register of clinical trials (updated on May 1, 2014). The criteria for inclusion were: random allocation to treatment with at least one group receiving dobutamine, enoximone, levosimendan, or milrinone and at least another group receiving the above inodilators or placebo, performed in cardiac surgical patients. The endpoint was to identify differences in mortality at longest follow-up available.
RESULTS:
The 46 included trials were published between 1995 and 2014 and randomised 2647 patients. The Bayesian network meta-analysis found that only the use of levosimendan was associated with a decrease in mortality when compared with placebo (posterior mean of OR=0.48, 95% CrI 0.28 to 0.80). The posterior distribution of the probability for each inodilator to be the best and the worst drug showed that levosimendan is the best agent to improve survival after cardiac surgery. The sensitivity analyses performed did not produce different interpretative result.
CONCLUSION:
Levosimendan seems to be the most efficacious inodilator to improve survival in cardiac surgery.
and there is the potential of (see below)...why would TENX have paid $500'000 to get access to the trial data in the UK ?!
Sepsis is a life-threatening condition that causes the blood pressure to fall dangerously, compromising blood flow to vital organs such as the liver and kidney. It is the leading cause for admission to an intensive care unit in the UK, accounting for about 30% of all admissions. Despite advances in treatment around 40% of such patients unfortunately die.
Conventionally, adrenaline-like drugs are used to support a patient’s blood pressure but they can have serious side effects. Levosimendan is a new type of drug that is currently used to treat patients with advanced heart failure. It works in a different manner to adrenaline-like drugs, potentially avoiding some of these side effects. It may also improve the blood flow to vital organs. In small scale clinical trials in patients with sepsis who have been given levosimendan significant improvements were seen in the function of the heart, kidneys and other organs.
Septic shock is a medical condition as a result of severe infection and sepsis, though the microbe may be systemic or localized to a particular site.[1] It can cause multiple organ dysfunction syndrome (formerly known as multiple organ failure) and death.[1] Its most common victims are children, immunocompromised individuals, and the elderly, as their immune systems cannot deal with the infection as effectively as those of healthy adults. Frequently, patients suffering from septic shock are cared for in intensive care units. The mortality rate from septic shock is approximately 25–50%.[1]
259 patients enrolled, over 50% reached! - septic shock- updated number of Leopards-trail UK
www.leopards-trial.org
It is not about riding this thing to the end...
You still fail to explain and proof your point that the "marketable securities" on the balance sheet of TenaxTherapeutics are in fact TENX shares "to be issued in the future".
Where are the $40 million gone? Don't you think TENX would need to announce a share buy back if that position (marketable securities) in the balance sheet would really be shares of their own company? simply because "to be issued shares" will never, ever appear as marketable securities in a balance sheet, period.
GLTA
Your wrong statement about the marketable shares position on the balance sheet of TENAX is not closed.
You fail again to deliver an explanation about the $40M which are obviously "missing" if you want to uphold your statement that marketable securities is a postion of shares to be issued in the future.
Your arguments simple do not add up, your allegations are irrational and end points just known facts.
Isn't it obvious that a R&D Biotech company which doesn't have an approved product on the market can not generate revenues through sales?! Isn't it obvious that such a company is funding its general expenses, reserach and salaries by issuing shares and debt instruments by receiving certain government grants and by managing the excess cash position to generate some revenues on the capital market?!
Again - TENX has sufficient funds to complete phase 3 study in LEVO-CTS LCOS, period. TENX does not need and will not issue new shares to fund this study, period.
Michael Jebsen, Chief Financial Officer, said: "We believe that our current capital will be sufficient to fund our levosimendan program in LCOS through a New Drug Application filing. We also remain in a strong position to proactively evaluate business development opportunities during calendar year 2015, including levosimendan’s expansion in septic shock and potential additional candidates that fit into our critical care pipeline strategy.”
TENX has fast track FDA status for LCOS
The FDA Fast Track Designation is a designation of the United States Food and Drug Administration (FDA) that facilitates the development, and expedites the review, of drugs which treat a serious or life-threatening condition and fill an unmet medical need.
The purpose of Fast Track designation is to get important new drugs to the patient earlier.
Phase 3 study LCOS has 44 patients enrolled and 41 hospitals activated and accelerating.
Phase 2/3 study for septic shock in the UK - Leopards has enrolled 250 patients and will be finished this year. www.leopards-trial.org
TENX will present in New York in April.
Only results not comments will decide about the future of this company.
the term "earned" was not used.
You fail to explain where the $40 million from the last years capital raise have gone, when you still claim that the marketable securities position on the balance sheet are shares TENX might issue in the future!
if a position on the balance is "marketable securities" it had to be acquired in the first place and not in the future as you say. You said marketable securities on the balance sheet are TENX shares to be issued in the future, just nonsense.
Those marketable securities have been acquired with money which came from the capital raise last year by issuing shares at that time, the point is simple and has no angle.
TENX shares do not qualify as "marketable securities" , if the position on the balance sheet in fact would be TENX shares then technically TENX had to invest in their own shares that it would qualify to be on the balance sheet), but if this position of "marketable securities" is TENX shares then the management is using wrong terminology and misleads all investors, which I do not think is the case.
Where are the $40 million?
You basically say that TENX has made $40 million disappear?[/b]please explain. as per balance sheet TENX has invested $40 million in marketable securities and not in "the future issued share nonsense", shares to be issued can not be declared as marketable securities on a balance sheet, period.
You seriously believe that TENX shares actually qualify for marketable securities?
and
the term "raising funds" is a financial term which also applies when shares are issued.
WIWWY?
eventually only data/trial results will decide about the future of this company,
Zero or a multiple of todays price, GLTA
Almost funny....
unfortunately TENX shares do not qualify as marketable securities as the liquidity in the market is not given at this stage and such an amount could not be sold at current market price without a discount. Refer to the definition - marketable securities can be converted to cash with great ease. Shares of IBM and government bonds are excellent examples of marketable securities.
TENX raised almost $60million last year, so those funds are spent ?! haha - where have they gone?!
read the balance sheet.
call the company yourself you will see...
DEFINITION OF 'MARKETABLE SECURITY'
Any equity or debt instrument that it readily salable and can be converted into cash, or exchanged with ease. Stocks, bonds, short-term commercial paper and certificates of deposit are all considered marketable securities because there is a public demand for them and because they can be readily converted into cash.
INVESTOPEDIA EXPLAINS 'MARKETABLE SECURITY'
Whereas shares in private corporations are illiquid, marketable securities can be converted to cash with great ease. Shares of IBM and government bonds are excellent examples of marketable securities. Marketable securities provide investors with the liquidity of cash and the ability to earn a return when the assets are not being used.
absolut nonsense, they have raised sufficient funds last year, and they invested in marketable securities, about $40 million, which they can liquidate when needed It is called cash management.
Correction - LEVO-CTS trial - 44 patients enrolled, 41 sites activated and going !
sufficient funds until 2017 !
septic shock in the game ! market potential enormous !
The Company continues to expect that its cash balance, including the fair value of its marketable securities, will be sufficient for it to accomplish its corporate goals through fiscal year 2017.
Michael Jebsen, Chief Financial Officer, said: "We believe that our current capital will be sufficient to fund our levosimendan program in LCOS through a New Drug Application filing. We also remain in a strong position to proactively evaluate business development opportunities during calendar year 2015, including levosimendan’s expansion in septic shock and potential additional candidates that fit into our critical care pipeline strategy.”
41 patients enrolled ! 40 sites activated! ongoing discussions with additional 13 U.S. sites.
LEVO-CTS trial is moving and accelerating!
Today, Tenax announced that the Company has currently enrolled 41 patients in the LEVO-CTS trial, and has 40 clinical sites activated with an additional 8 sites where contract negotiations have been completed. The Company also disclosed that it has discussions ongoing with an additional 13 U.S. sites.
http://finance.yahoo.com/news/tenax-therapeutics-announces-third-quarter-100000942.html
don't worry - be happy and maybe surprised !
this was not a PR of the company but an official study: but wait there is no market because centuries ago some big company thought it was not worth pursuing, so it never will ?! and a different indication ?- and the world, opportunities, technology and demands have and will never change, haha...
This company has changed! agree, in the past they pretty much did everything wrong what could have done wrong but now.....
“This manuscript is the most updated and methodologically strongest meta-analysis on the effect of inodilators on mortality in cardiac surgery. Using Bayesian network meta-analyses techniques, we attempted ranking among different inodilators that have never properly been compared one each other, and identified levosimendan to be the best inodilator to improve survival in adult cardiac surgery.”
“These publications indicate that levosimendan is the best inodilator to improve survival in adult cardiac surgery patients and acts as a ‘safety net’ in this critical care setting,” said John Kelley, CEO of Tenax Therapeutics. “We believe the conclusions drawn in these publications are highly supportive of our LEVO-CTS trial design and expectations regarding our study results.”
The highlighted publications include:
“Preoperative and perioperative use of levosimendan in cardiac surgery: European expert opinion,” International Journal of Cardiology; Toller, et al. The publication provides a review of the scientific literature as well as consensus recommendations from a panel of 27 experts from 18 countries regarding the preoperative use of levosimendan in cardiac surgery patients. Their recommendations support the LEVO-CTS study design in several ways – specifically, the consensus publication recommends pre-operative dosing and use in low ejection fraction coronary artery bypass and valve surgery patients. Their conclusion also generally supports the LEVO-CTS study endpoints, stating:
“Clinical studies show that levosimendan effectively improves general and pulmonary haemodynamics in patients undergoing cardiac surgery, thereby reducing the need for inotropic agents and mechanical circulatory support, and additionally optimising renal and hepatic function. In general, the length of stay in the ICU and in the hospital is shortened. Overall, levosimendan treatment is considered as a kind of ‘safety net’ in the surgical setting.”
The article was first published online on February 24, 2015, and can be accessed here: http://www.internationaljournalofcardiology.com/article/S0167-5273(15)00149-7/abstract
“A Bayesian network meta-analysis on the effect of inodilatory agents on mortality,” British Journal of Anaesthesia; Greco, et al. Dr. Greco and his co-authors published the findings of a meta-analysis they conducted to assess differences in mortality associated with various inodilator products that are commonly used in critical care patients. Their study included 46 trials published between 1995-2014 and concluded that levosimendan appears to be the most efficacious inodilator product to improve survival when used in cardiac surgery patients. As stated in their conclusion:
“This manuscript is the most updated and methodologically strongest meta-analysis on the effect of inodilators on mortality in cardiac surgery. Using Bayesian network meta-analyses techniques, we attempted ranking among different inodilators that have never properly been compared one each other, and identified levosimendan to be the best inodilator to improve survival in adult cardiac surgery.”
The article was first published online on February 4, 2015, and the abstract can be accessed here: http://bja.oxfordjournals.org/content/early/2015/02/04/bja.aeu446.abstract