Groundbreaking study to assess safety of drugs passed through breastmilk

February 13, 2018 -The study is being conducted by the Pediatric Trials Network, which is led by the DCRI.

The Pediatric Trials Network (PTN) is undertaking a groundbreaking study to assess the safety of commonly used off-patent medications when they are given to breastfeeding mothers. The study will track how different drugs are passed through breastmilk to determine dosing levels that are safe for both mom and baby.

The PTN was founded to promote and support studies of on- and off-patent drugs in children. The DCRI is a member of the network’s core leadership.

Kevin WattAlthough the U.S. Food and Drug Administration (FDA) has implemented a guidance document on conducting lactation studies, off-patent drugs are not included in that rule. The PTN seeks to fill this knowledge gap.

“Although the benefits of breastfeeding are well-documented, we still don’t know enough about the effects of many prescription and over-the-counter off-patent drugs when they are passed to infants through their mother’s breastmilk,” said the DCRI’s Kevin Watt, MD, PhD, who is leading the study. “As a rule, we discourage unnecessary drug use during lactation, but it’s quite common for new mothers to have symptoms or medical conditions that must be treated with drugs.”

“Many breastfeeding moms struggle with the decision to take medications because of the fear that these drugs will harm their children,” Watt said. “In the end, it often comes down to either stopping breastfeeding or discontinuing needed medications. We want to take the guesswork out of this difficult decision and allow moms to breastfeed without worry.”

The study is expected to begin in April of 2018 and will enroll approximately 50 lactating women, along with their breastfed infants, for each drug studied. Initially 10 off-patent drugs will be studied, including medications used to treat bacterial infections, depression and anxiety, high blood pressure, diabetes, and chronic pain. Mothers will be enrolled in the study only if they are already taking one of the study drugs as part of their routine care.

Mothers who participate in the study will provide samples of breastmilk, their blood, their infants’ blood, or a combination to help researchers measure drug levels and determine the safest dose. Mothers and infants are expected to remain in the study until the infants reach 180 days of age.

The study, supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), will also explore the effects of maternal obesity on drug exposure and long-term outcomes of breastfed infants exposed to drugs in breastmilk.

See the NIH LactMed database for more information on the levels of various substances in breastmilk and infant blood, and possible adverse effects.

Prediction model developed by DCRI faculty being used by researchers around the world

February 6, 2018 – A novel prediction model for preventing major infections after cardiac surgery developed by DCRI faculty is being utilized globally by surgeons and researchers in broad clinical areas.

In 2005, DCRI researchers created and validated a novel bedside scoring system to estimate risk for major infection in patients undergoing cardiac surgery. Published in Circulation, the official journal of the American Heart Association, the paper is currently being used in research studies, clinical trials and various other therapeutic areas around the world.

Though infrequent, major infections can complicate cardiac surgery, especially after a median sternotomy, a type of surgical approach in which a long, vertical inline incision is made along the breastbone providing access to the thoracic cavity.

Vance Fowler“In late 2004, we identified a link between the specific characteristics of patients, in particular, the bacteria they are infected with, and the likelihood of the development of mediastinitis, one of the most devastating complications of cardiac surgery,” said the DCRI’s Vance G. Fowler, MD, first author of the paper.

Fowler proposed using the Society of Thoracic Surgeons (STS) National Cardiac Database to single out patients more likely to acquire an infection following a median sternotomy, using operative characteristics that could be associated with identifying high risk for subsequent surgery.

“The operative characteristics were important because they could be identified preoperatively, which allowed surgeons and caretakers to potentially intervene and take necessary measures to reduce the risk of perioperative and postoperative infections,” said Fowler.

Established in 1989 to report surgical outcomes after cardiothoracic surgical procedures, the STS database captures clinical information from nearly two thirds of all US bypass procedures from more than half of all centers performing adult cardiac surgery.

Using the STS database, the researchers effectively created a model with a simple scoring system where specific characteristics were identified as ‘more’ or ‘less’ associated with risk. The risk score generated by the scoring system accurately identified high-risk patients who could benefit from targeted interventions to reduce the likelihood of serious infection after cardiac surgery.

“Because the STS database was so large, with rich detail captured on the preoperative and perioperative details of hundreds of thousands of patients, we were able to include a great deal of clinical details in the model scoring system,” said Fowler.

Since the model is not patented, it has been widely used all over world in research studies, clinical trials and in various therapeutic areas, the most recent being in the cardiothoracic surgery ICU at Hospital São João in Oporto, Portugal, the largest cardiothoracic surgery facility in the country.

The staff at Hospital São João is using Fowler’s scale for the prevention of wound complications resulting from infection after chest surgery. In accordance with the scale, the facility is using incisional negative pressure wound therapy in patients that present risk of infection.

According to Viviana Goncalves, a cardiothoracic surgery ICU nurse at Hospital São João, all major wards of cardiothoracic surgery in Portugal are using Fowler’s scale for prevention of infection. The hospital hopes to translate and validate the scale in Portugal to develop surgical protocols.

“Our investigation identified and validated several risk factors available to the clinician in the preoperative setting that are now being used internationally to identify patients at risk for major infection,” said Fowler.

In Depth: The DCRI’s Bradley Kolls on new stroke guidelines

January 29, 2018 – The updated guidelines were issued last week at the 2018 International Stroke Conference.

Last week the American Heart Association and American Stroke Association issued new guidelines for the management of ischemic strokes, which account for about 85 percent of all strokes. The new guidelines expand the window for thrombectomy from six to 24 hours, based on the results of brain imaging in select patients. We asked the DCRI’s Bradley Kolls, MD, associate professor in the Department of Neurology, to weigh in on the implications of these changes.

What do the new guidelines mean for clinicians?

Within the new guidelines we now have the highest level of evidence for interventional treatment of the largest and most devastating stroke, those that result from large vessel occlusions. Much like ischemic myocardial infarction 20 years ago, percutaneous intervention with catheters and clot removal tools have been found to be superior than just blood clot lysis therapy alone. What is even more exciting is that new studies using these interventional approaches are showing benefit to patients at very extended time periods after onset, now up to 24 hours after the last time patients were seen well. These new criteria for identifying patients who will benefit from endovascular therapy represent another big step forward in acute stroke care and present some real challenges for us in terms of implementation into clinical practice.

What role does technology play in the new guidelines?

The selection criteria require the use of software to automate the interpretation of vascular imaging studies to determine specific features about the area of the brain that is involved in the stroke. The implementation of the software and developing the systems of care to obtain the needed testing and analysis in a timely way will require close partnerships with referring partner centers. Our telestroke system will offer a solid platform for deployment, though will take some time to coordinate across the centers in the network. The new guidelines also support the development of multidisciplinary teams within facilities that develop and enforce the use of a highly organized process for acute stroke assessment and evaluation. The use of goals for delivery of TPA and the further development of systems of care that begin with emergency medical services are all high-level supported aspects to optimal acute stroke care. Telemedicine was also addressed in the guidelines and there is growing evidence and support for the benefits of using a telestroke service to improve the care and delivery of TPA and other acute stroke interventions.

Do you have any concerns about the new guidelines?

Some of the guidelines around the care in the hospital lack strong recommendations despite being prominent aspects of care, and the current focus of many quality measures for stroke care. An example is the dysphagia screen and the use of deep vein thrombosis prevention such as subcutaneous heparin or low-molecular weight heparin. It seems the lack of data on clear benefit in terms of long-term outcome and the cost of these interventions has led to a modest support statement for what many stroke providers feel are critical aspects to stroke care and recovery. Similarly, the use of MRI and vascular imaging, and obtaining ECHOs (heart ultrasound) routinely to try to determine the cause for the stroke and implement appropriate secondary prevention strategies was not recommended. This is quite counter to current shared best practice by most centers and was hotly contested and debated at the open guidelines sessions. Again, lack of impact on outcomes and uncertain cost-benefit were cited as the reasons for the recommendations. However, many argue that absence of proof is not proof of absence. No one questions the improved outcomes of wearing a parachute when jumping from an airplane compared to not wearing one.

What do these guidelines mean for the future of stroke care?

Acute stroke care has seen some of the greatest advances in all of neurology over the past five years and we continue to find new and better ways to help patients having an acute stroke. Interventions on hemorrhagic stroke and intense research on the systems of stroke care will help even more patients receive the care they need in the shortest times possible, and hopefully will lead to continued gains in the functional outcomes and quality of life for our patients. The direct oral anticoagulants continue to be expanded in their use in stroke prevention and may one day become the best preventive strategy for most stroke patients and help reduce the need for the detailed testing that today forms the basis for controversy over the new guidelines. Stroke remains an exciting and evolving field and new technologies and therapies are rapidly converging in this field to completely change how we treat and manage acute stroke.

Prior NOAC use associated with lower mortality risk in intracerebral hemorrhage patients

January 25, 2018 – A new study suggests that NOACs are a safer choice than warfarin for patients on oral anticoagulants.

Heart patients who take non-vitamin K antagonist oral anticoagulants (NOACs) and subsequently experience intracerebral  hemorrhage (ICH) may be at greater risk of death than those who are not on NOACs, according to a new study by DCRI researchers. However, NOACS may still be safer than an older anticoagulant, warfarin.

The study was presented today at the International Stroke Conference in Los Angeles and published simultaneously in JAMA.

Taku InoharaNOACs are increasingly prescribed for high-risk patients with atrial fibrillation because they have fewer complications than warfarin. However, they still pose a risk of ICH. Prior to this study, it was unclear if NOAC patients who experienced an ICH were at greater risk of death than patients with no history of NOACs or patients who received warfarin.

In this study, led by DCRI Fellow Taku Inohara, MD, PhD, the researchers used data from the American Heart Association/American Stroke Association Get with the Guidelines –Stroke registry to identify patients who experienced ICH between October 2013 and December 2016. Among the 141,311 such patients they found, 15,036 (10.6 percent) were taking warfarin, 4,918 (3.5 percent) were taking NOACs prior to ICH, and 121,357 patients (85.9 percent) received no anticoagulants prior to ICH. Patients who were on anticoagulants prior to ICH were more likely to be older, white, and have a higher prevalence of atrial fibrillation, prior stroke, diabetes, and heart failure.

Acute ICH stroke severity, as measured by the National Institutes of Health Stroke scale, did not differ greatly among the three groups. Unadjusted in-hospital mortality rates were 32.6 percent for the warfarin group, 26.5 percent for the NOAC group, and 22.5 percent for the no prior use group. While prior use of both NOACs and warfarin was associated with a greater risk of in-hospital mortality, patients with prior use of NOACs were more likely to have favorable outcomes than patients with prior use of warfarin. In addition to improving patient outcomes, the researchers noted, NOACs may also be a better option than warfarin when concomitant antiplatelet therapy is required.

“These findings suggest that NOACs may be a better choice than warfarin for patients requiring oral anticoagulants,” Inohara said. “They also have the potential to inform future treatment selection when oral anticoagulation is warranted.”

In addition to Inohara, the study’s authors included Ying Xian, MD, PhD; Li Liang, PhD; Roland Matsouaka, PhD; Jeffrey Saver, MD; Eric Smith, MD, MPH; Lee Schwamm, MD; Matthew Reeves, PhD, Adrian Hernandez, MD, MHS; Deepak Bhatt, MD, MPH; Eric Peterson, MD, MPH, and Gregg Fonarow, MD.

PhRma Foundation awards grants for value-based and cost effectiveness research

January 16, 2018 – The awards will support research to assess the value of medicines and healthcare services while improving patient outcomes and reducing inefficiency.

Gillian Sanders SchmidlerDCRI researchers have received two of three grants recently awarded by the PhRma Foundation for work affecting the development of new value-based care models in the United States.

The DCRI Value Assessment Research awardees are Shelby D. Reed, PhD and Gillian Sanders Schmidler, PhD. Each grant is worth up to $100,000 over one year.

Reed’s project, conducted by the Preference Evaluation Research (PrefER ) Group at the DCRI, will center on establishing value in cancer care. Sanders Schmidler’s work will explore the impact of value-based care from multiple perspectives.

Concern over rising U.S. health care costs in recent years has increased interest in promoting high-quality care, while avoiding low value or inefficient care. In response, a number of initiatives aiming to drive value in health care have emerged, but few offer transformative solutions that reflect patient preferences and real-world clinical practice. In addition, many issues in methodology and patient engagement remain unresolved. The PhRMA Foundation launched its Value Assessment Initiative last year to help address these issues.

Pregnant women in NC exposed to less secondhand nicotine after ‘smoking ban’

January 11, 2018 – African-Americans, unmarried women, and those with less education were at higher risk.

A new study from Duke and DCRI researchers has found pregnant women experienced less secondhand smoke exposure since the 2009 passage of the ‘smoking ban’ in North Carolina, which outlawed smoking inside public places such as bars and restaurants. The research was published online in the International Journal of Environmental Research and Public Health.

Although overall, exposure has been reduced, the study identified racial and socioeconomic disparities among those who still are affected at home, at work and in their communities — specifically women who are African American, women with less education, and those who are unmarried.

The data comes from 668 women who enrolled in the study between 2005 and 2011. Their secondhand smoke exposure was measured by the presence of cotinine, a biomarker found in blood plasma that indicates nicotine exposure within the previous 48 to 72 hours.

CigaretteThe blood tests indicated that most non-smoking pregnant women were not exposed to nicotine in the days prior to being tested for the study. Although some women still had exposure after the passage of the ban, average levels of cotinine in their blood were lower than those before the ban.

The study focused on the Southeast, a part of the United States that has some of the highest rates for poor perinatal outcomes, said the study’s lead author, Julia Schechter, PhD, a clinical psychologist and assistant professor at Duke Health. Smoking and secondhand smoke exposure can contribute to complications including miscarriage, low birth weight, early birth and learning and behavioral deficiencies in children.

“North Carolina still doesn’t have a fully comprehensive smoking ban,” Schechter said. “The findings are encouraging, but we still aren’t completely smoke free.” Considering many communities in the region have roots in tobacco farming and production, continued policy change may be particularly challenging, she said.

Schechter and colleagues are also conducting research on potential links between smoke exposure during pregnancy and ADHD.

The DCRI’s Scott Kollins was senior author of the study. In addition to Kollins and Schechter, study authors include Susan K. Murphy and Junfeng (Jim) Zhang of Duke, Bernard F. Fuemmeler of Virginia Commonwealth University, and Cathrine Hoyo of N.C. State University.

The research was supported by National Institute of Environmental Health Sciences of the National Institutes of Health (P01ES022831, R21ES014947, R01ES016772, K24DA023464, P30ES025128) and by the U.S. Environmental Protection Agency (RD-83543701). Additional support was provided by the National Center for Research Resources, a component of the NIH and NIH Roadmap for Medical Research (UL1TR001117).

Researchers develop new model to predict progression to Alzheimer’s in patients with mild cognitive impairment

January 8, 2018 – The progression to Alzheimer’s disease (AD) can be more accurately predicted in patients by incorporating longitudinal profiles of multiple clinical and neuroimaging markers in addition to the baseline information, say researchers.

In a recent study published in Alzheimer’s & Dementia, the official journal of the Alzheimer’s Association, researchers describe how novel statistical models could improve the prediction of progression-free survival in mild cognitive impairment (MCI) patients using multiple markers, all of which can be easily collected in a clinical setting.

Sheng Luo“We have a burgeoning prevalence of AD because of the increasing number of people age 65 and older in the United States,” said Sheng Luo, PhD, senior author of the report and corresponding author of the study. “Given that the number of new cases of Alzheimer’s and other dementias is projected to soar and the lack of modifying treatments for the disease, the question that we wanted to ask in this manuscript was how do we characterize the progression of AD for early detection and intervention in patients with MCI,” he said.

Alzheimer’s–a general term for memory loss and other cognitive abilities severe enough to restrict daily life–is the most common form of dementia, accounting for 60 to 80 per cent of dementia cases. The number of Americans living with Alzheimer’s disease is growing with an estimated 5.5 million Americans living with Alzheimer’s disease and dementia in 2017. Many patients with MCI will go on to develop AD.

Using data from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) study, Luo and his team assessed the combined prognostic value of longitudinal neurocognitive tests measured over time during a patient’s regular visit, as well as neuroimaging, genetics, and cerebrospinal fluid (CSF) markers in determining the risk of AD conversion among individuals with MCI. According to the researchers, the ADNI data was very well suited for the tasks because of its large sample size, long follow-up period, wide breadth of cognitive markers and biomarkers, and prospective design.

The researchers used the weighted combination of historical information of five neurocognitive longitudinal markers that are routinely collected in observational studies to develop their prognostic model. The comprehensive validity analysis provided solid evidence of the usefulness of the model for predicting AD progression.

“Our analyses showed that prognostic performance can be greatly improved by using longitudinal neurocognitive tests compared with just using their baseline measurements,” said Luo.

According to Luo, the benefit of having a better prognosis of developing AD are manifold in the sense that it will not only help a patient’s caring clinicians better direct their targeted therapies and treatments to slow down the progression of the disease but also allow patients with a high chance of developing AD to be more proactive in making important physical and mental lifestyle changes.

“The main contribution of the study is that it can be used not only as a valuable prognostic tool but can also prove helpful to the research community at large where they can use this particular tool in their current datasets,” said Luo. “Also, for clinical trials, this prognostic tool can be helpful in identifying subjects likely to develop AD in the timeframe of the trial,” he said.

According to Luo, their method can also be applicable to many other neurodegenerative disorders with similar disease and data structures and multiple longitudinal variables such as Parkinson’s Disease, Huntington’s Disease and ALS.

“If you apply this particular methodology to other studies of different diseases you can derive similar prognostic tools with slight modifications,” he said.

In addition to Luo, other co-authors include Kan Li, Richard O’Brien, and Michael Lutz. The study was supported by the National Institute of Neurological Disorders and Stroke.

Datavant selects DCRI as founding academic partner to accelerate innovation in data-driven clinical research

January 5, 2018 – Datavant and the DCRI will work closely together in engaging biopharmaceutical partners and implementing innovative approaches to clinical trial design and interpretation, leveraging the power of their combined datasets. 

Datavant, a healthcare technology company that aggregates and structures healthcare data to generate actionable insights for clinical trials, has selected the DCRI as an analytical partner to accelerate data-driven approaches in drug development, the company announced today.

As Datavant’s Founding Academic Partner, the DCRI will bring deep insights and unique perspectives on data-driven clinical research and access to clinical trial and health system data to augment Datavant’s analytical tools and data assets. The DCRI will gain early access to Datavant’s data and technology. Together, the organizations will create further opportunities to facilitate rapid scaling of best practices in clinical research to improve patient outcomes.

Michael Pencina

“New clinical insights come from matching the right question with data that can actually inform its answer,” said Michael J. Pencina, PhD, the DCRI’s director of biostatistics and a professor of biostatistics and bioinformatics at Duke School of Medicine. “The promise of this partnership comes from the blend of the DCRI’s analytic innovations with Datavant’s unique datasets, creating unmatched capacity for discovery.”

“Too many drugs fail clinical trials due to deficiencies in trial design and interpretation, depriving patients of new treatment options they desperately need.  We believe that the combination of DCRI’s analytical expertise and rich datasets combined with Datavant’s products and data hold the potential to be transformative for the industry,” said Travis May, co-founder and CEO of Datavant.

Initial collaboration will be focused on focused on phase II design in cardiopulmonary space.

Heart patients help doctors determine best aspirin dose

January 4, 2018 – The ADAPTABLE study, coordinated by the DCRI, will enroll as many as 15,000 cardiac patients to determine the optimal aspirin dose.

Doctors have known for decades that taking aspirin can reduce the risk for future heart attacks and strokes in people with cardiovascular disease. What is less clear is which dose is best. Participants in a new kind of clinical trial are helping them find out.

Some doctors prescribe a “baby aspirin” (81mg) once a day, while others recommend a full-strength (325mg) aspirin tablet. The difference is important because taking aspirin daily can potentially increase your risk of bleeding. Until now, there hasn’t been enough good-quality data to guide doctors’ decisions.

That’s where the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness) study comes in. The DCRI is coordinating the study, one of the first to make patients key partners in an effort to gather vast amounts of data quickly and efficiently. People with heart disease and who are at high risk of having a heart attack or stroke are randomly assigned to take an 81mg or 325mg aspirin daily and are followed for up to 30 months. Eventually, as many as 15,000 people around the U.S. will participate.

Patients Appreciate Opportunity to Advance Medical Knowledge

Retiree John Turk started having shortness of breath and chest tightness while juggling the stresses of selling his Cleveland, OH, home and buying a new one in Raleigh to be near his daughter. He hadn’t had symptoms before.

“My general practitioner immediately referred me to Duke to get checked out,” Turk said. “Within a few weeks, I had bypass surgery.” Duke interventional cardiologist Schuyler Jones, MD, worked with Turk during his post-surgical recovery period and encouraged him to get involved in the ADAPTABLE study.

“If this helps, I’m glad to be part of it,” Turk said. “Makes me feel good to help with the research.”

For full story from Duke Health Blog:

MURDOCK COPD Study enrolls 300th participant

December 19, 2017 – MURDOCK COPD investigators led by the DCRI’s Scott Palmer, MD, hope to enroll 850 patients.

The first time Joseph Griggs met Nellie Griggs, he made a bold prediction.

“You’re going to be my wife,” Joseph told Nellie in August 2001 while they chatted in a New York City park.

Nellie wasn’t so sure.

“I told him he was crazy,” she said, as the couple reminisced in their Kannapolis home. “But after that, we became inseparable.”

The New York natives moved to Kannapolis in 2002 and were married at the Cabarrus County Courthouse. Fifteen years later, they remain nearly inseparable and share a common goal: They hope to improve the health of future generations by joining the MURDOCK COPD Study, managed by the Duke Clinical and Translational Science Institute (CTSI) in Kannapolis at the North Carolina Research Campus.

Nellie recently became the 299th participant in the study, and Joseph enrolled the next day as No. 300. The Duke team aims to enroll 850 people in the study and follow their health for up to five years. To qualify, participants do not need to have COPD, which stands for chronic obstructive pulmonary disease, but they must have smoked.

Duke researchers are studying the severity of smoking-related symptoms in participants and following the progression of their lung function to better understand the disease. The study could help doctors provide better care for their patients and more effective treatments in the community setting, according to Scott Palmer, MD, director of respiratory research for the DCRI and principal investigator for the study.

“I think it’s wonderful,” Joseph said. “It will help people later on if researchers can understand COPD. I want them to know more about what’s going on, because I have it. If we can help them by joining the study, then we feel like we’ve done our part.”

Chronic lower respiratory diseases, which include COPD, are the third-leading cause of death in the United States.

MURDOCK COPD 300th patientParticipation in the study by people like Nellie and Joseph, who started smoking as teenagers, provides a way for researchers to compare the current system for classifying the stages of COPD to disease development and progression in a real-world setting.

“Much of what we have learned about COPD to date has been gathered from research done in large academic medical centers,” said Jamie Todd, MD, assistant professor of medicine in the DCRI and co-principal investigator of the study. “But for this study, we have the unique opportunity to work with the MURDOCK Study to better understand the progression and management of COPD in a community setting.”

Joseph, 57, coughs and tires easily now, but growing up in Brooklyn, he played baseball and football, drove a truck, and worked as a mechanic. A former boxer and chef, Joseph had to quit sports and his job when he suffered a stroke in 2010.

Nellie, 51, grew up in the Bronx with 10 siblings and worked for the City of New York in a variety of jobs, including helping people who received public assistance find work. She suffered kidney failure last year and receives dialysis three days a week while awaiting a kidney transplant.

“I would like to give her one of mine,” Joseph said, “but I am not a match.”

Nellie and Joseph moved back to New York a few years ago to care for their ailing mothers. They returned to Kannapolis in 2016, drawn by the mild winters and lower cost of living. Without a car, they call a cab or have friends shuttle them to health care appointments. For errands, Nellie walks and Joseph uses a motorized scooter.

Sixteen years after Joseph asked Nellie if he could buy her a Pepsi on a hot summer day, the couple count their blessings daily, despite their many health problems. They are intrigued by the transformation of Kannapolis into a research hub, and proud that they have contributed by joining the MURDOCK COPD Study.

“I like the idea of Kannapolis being about research,” Joseph said. “Helping sick people, that’s what we need to do.”

“We feel good about being in the study,” Nellie added. “We are blessed.”

Current or former smokers who are at least 40 years old could qualify to join the MURDOCK COPD Study. No geographic restrictions apply. During study follow-up, Duke CTSI in Kannapolis will contact participants every six months to measure changes to their health.

To learn more, call 704-250-5861, send an email to or visit Participants will be offered compensation for each in-person visit.

The MURDOCK Study, DCRI, and Boehringer Ingelheim Pharmaceuticals Inc. are collaborating on the study.