Dr. Bano[/caption]
Arjola Bano, MD, MSc, DSc
Researcher in the Departments of Internal Medicine and Epidemiology,
Erasmus Medical Center, Rotterdam
the Netherlands
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Thyroid function is clinically defined by the measurements of serum thyroid stimulating hormone (TSH) and free thyroxine (FT4) levels. So far, abnormal TSH and FT4 levels as well as variations within the normal range have been linked to an increased risk of cardiovascular disease and death. However, it remains unclear whether there are differences in life span and years of life lived with and without cardiovascular disease, within the reference range of thyroid function. To investigate this, we performed a prospective study among 7785 middle-aged and elderly people with normal thyroid function. Participants were part of the Rotterdam Study, 65 years on average and 52% females. In our statistical analyses, we accounted for sociodemographic and cardiovascular risk factors. Over a median follow-up of 8.1 years, 789 incident cardiovascular deaths and 1357 deaths occurred. Analyses were performed separately among men and women.
Our study found differences in life expectancy within the reference range of thyroid function. At the age of 50 years, people with low-normal thyroid function lived up to 3.5 years longer than those with high-normal thyroid function. Also, people with low-normal thyroid function lived a longer life without cardiovascular disease than those with high-normal thyroid function.
Dr. Alosco[/caption]
Michael Alosco, PhD
NRSA Postdoctoral Fellow
Boston University Alzheimer’s Disease & CTE Center
Boston University School of Medicine
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: TThe goal of this study was to investigate whether playing youth tackle football, particularly before the age of 12, is associated with worse emotional, behavioral, and cognitive difficulties later in life. Participants in this study included 214 former amateur and professional American football players who were part of the LEGEND study at Boston University. Participants had an average age of 51. 43 played high school football, 103 played college football, and there were 68 professional American football players. The former players were divided into two groups: those who began playing tackle football before age 12 and those who began at age 12 or older. Participants received telephone-administered cognitive tests and completed online measures of depression, behavioral regulation, apathy, and executive functioning, such as initiating activity, problem-solving, planning, and organization. Results from former players who started playing tackle football before the age of 12 were compared to those of participants who started playing at age 12 or later.
The study showed that participation in tackle football before age 12 increased the odds for having problems with behavioral regulation, apathy and executive functioning by two-fold and increased the odds for clinically elevated depression scores by three-fold. These findings were independent of the total number of years the participants played football or at what level they played, such as high school, college, or professional. Even when a specific age cutoff was not used, younger age of exposure to tackle football corresponded with worse clinical status.
Dr. Siegel[/caption]
Professor Michael Siegel, MD, MPH
Department of Community Health Sciences
Boston University School of Public Health
Boston, MA 02118
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Each year, more than 1,800 people in the U.S. are killed by their intimate partners. Approximately half of these homicides are committed using firearms. While federal law prohibits people subject to domestic violence restraining orders from possessing firearms, there is no requirement that they surrender guns already in their possession.
To close this loophole, several states have enacted laws that not only prohibit gun possession by people subject to restraining orders, but which also explicitly require that they relinquish weapons that they already have. If you are unclear as to the laws of your state, then you should contact a local law firm, such as this nyc lawyer, to discuss your current circumstances.
In this study, we investigated the impact of state domestic violence-related firearm laws and rates of intimate partner homicide, using data from all 50 states over a 25-year period, 1991-2015.
Dr. Harris[/caption]
Kevin M. Harris, MD
Director, Fellowship Training; Director, Echocardiography
Allina Health, Minnesota
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Triathlon is a popular endurance sport which combines swimming, bicycling and running. We investigated the death rate in the triathlon since its inception in the United States in 1985 through 2016. Specifically we were able to look at the rate of death in USAT races from 2006 to 2016.
We identified 135 deaths/cardiac arrests over the time period. 85% of victims were male and victims averaged 47 years. Most deaths and cardiac arrests occurred in the swim. 15 of the deaths were traumatic occurring during the bike portion. The rate of death was 1.74 per 100,000 participants. The death rate was significantly higher for males than females and increased significantly for men > 40 years. On autopsy, nearly half of those victims were found to have significant cardiovascular disease.
Dr. Filippidis[/caption]
Filippos Filippidis MD MPH PhD
Lecturer in Public Health
School of Public Health
Imperial College London
London
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Smoking kills millions of people every year. It is well established that increasing tobacco prices is the most effective way to reduce tobacco consumption and hence mitigate the devastating effects of tobacco on health. Taxation on tobacco products is high in the European Union, which makes cigarettes less affordable. However, transnational tobacco companies are known to manipulate prices, ensuring that cheap or ‘budget’ cigarettes are still available. This is particularly important for younger smokers and those of low socioeconomic status who are more sensitive in price increases.
Smoking during pregnancy, as well as exposure of pregnant women and babies to cigarette smoke increase infant mortality. There is also evidence that increasing tobacco prices is associated with lower infant mortality. However, researchers typically use average or premium cigarette prices. We analysed 54 million births from 23 European Union countries to see if the differential between average priced and budget cigarettes (i.e. the availability of cigarettes much cheaper than average priced ones) is associated with infant mortality.
We found that increasing average cigarette prices by 1 Euro per pack was associated with 0.23 fewer deaths per 1,000 live births in the same year and an additional 0.16 fewer deaths per 1,000 live births in the following year. A 10% increase in the price differential between budget and average priced cigarettes was associated with 0.07 more deaths per 1,000 live births the following year. This means that 3,195 infant deaths could potentially have been avoided in these 23 countries if there was no price difference between cigarette products over the 10-year study period.
Dr. Kirkegaard[/caption]
Hans Kirkegaard, MD, PhD, DMSci, DEAA, DLS
Research Center for Emergency Medicine and
Department of Anesthesiology and Intensive Care Medicine
Aarhus University Hospital and Aarhus University
Aarhus, Denmark
MedicalResearch.com: What is the background for this study?
Response: In 2002, two landmark studies demonstrated that mild therapeutic hypothermia (now known as targeted temperature management, TTM) for 12 or 24 hours improves neurological outcome in adult comatose patients suffering from out of hospital cardiac arrest. Accordingly, international guidelines now recommend TTM for at least 24 hours in this patient group.
However, there are no studies, only case reports that explore the effect of prolonged cooling. We therefore wanted to set up a trial that could fill out this knowledge gap, we hypothesized that doubling the hypothermia dose to 48 hour would improve neurological outcome without increasing the risk of adverse events considerably.
Dr. Rhee[/caption]
Dr. Chanu Rhee MD, Assistant Professor
Therapeutics Research and Infectious Disease Epidemiology Group
Department of Population Medicine at Harvard Medical School / Harvard Pilgrim Health Care Institute
Critical Care and Infectious Disease Physician
Transplant/Oncology Infectious Disease service and
Medical Intensive Care Unit at Brigham and Women’s Hospital
MedicalResearch.com: What is the background for this study?
Response: Multiple studies suggest that the incidence of sepsis, the syndrome of life-threatening organ dysfunction caused by infection, is increasing over time, while mortality rates are decreasing. However, reliably measuring sepsis incidence and trends is challenging because clinical diagnoses of sepsis are subjective and insurance claims data, the traditional method of surveillance, can be affected by changing diagnosis and coding practices over time.
In this study, my colleagues and I estimated the current U.S. burden of sepsis and trends using clinical data from the electronic health record systems of a large number of diverse hospitals. The findings, published in JAMA, challenge the use of claims data for sepsis surveillance and suggest that clinical surveillance using electronic health record data provides more objective estimates of sepsis incidence and outcomes.
Dr. Cannon[/caption]
Professor Christopher P. Cannon MD
Executive Director, Cardiometabolic Trials, Baim Institute
Cardiologist Brigham and Women's Hospital
Baim Institute for Clinical Research
Columbia University College of Physicians and Surgeons
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The trial explored whether a dual therapy approach of anticoagulation and P2Y12 antagonist - without aspirin - in non-valvular atrial fibrillation (AF) patients following percutaneous coronary intervention (PCI) and stent placement would be as safe, and still efficacious, as the current standard treatment – triple therapy. For more detailed background on the study, readers may want to review the first paragraph of the article in the New England Journal of Medicine.
Results showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with dabigatran, when compared to triple therapy with warfarin.
In the study, the risk for the primary safety endpoint (time to major or clinically relevant non-major bleeding event) was 48 percent lower for dabigatran 110 mg dual therapy and 28 percent lower for dabigatran 150 mg dual therapy (relative difference), with similar rates of overall thromboembolic events.
Dr. Dorman[/caption]
Susan E. Dorman, M.D
Associate Professor of Medicine, Division of Infectious Diseases
Johns Hopkins University School of Medicine, Baltimore
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Tuberculosis, also called “TB” is one of the top 10 causes of death worldwide, according to the World Health Organization. TB is caused by bacteria called Mycobacterium tuberculosis. In 2015, over 10 million people became sick from TB and 1.8 million people died from TB. This is a lot of people – diagnosing and treating TB to improve their health is important. Because TB usually involves the lungs, it can be passed from person to person through the air, and thus, diagnosing and treating TB is critical to reduce the spread of TB. Drug-resistant TB -- TB caused by bacteria that are resistant to commonly used TB antibiotics -- is a serious problem. In 2015 an estimated 480,000 people had multidrug-resistant TB.
We have been working to develop better, faster ways to diagnose TB and drug-resistant TB. A new test was developed as a partnership between Rutgers University and Cepheid (Sunnyvale, CA), and development was supported by the US National Institutes of Health (NIH). The new test was designed to detect Mycobacterium tuberculosis bacteria in sputum, and to simultaneously detect whether the bacteria are resistant to several of the main antibiotics (isoniazid, fluoroquinolones, and aminoglycosides) used to treat TB. The test takes about two hours from sample to result.
The NEJM article describes the results of a study that was undertaken in China and South Korea to understand how well the new test works, compared against gold standard tests.
Dr. Menzies[/caption]
Dr Alexander Menzies BSc(Med) MBBS (Hons) FRACP PhD
Medical Oncologist and Senior Research Fellow at Melanoma Institute Australia
The University of Sydney and Royal North Shore and Mater Hospital
MedicalResearch.com: What is the background for this study?
Response: For early-stage melanoma, surgical resection is the standard treatment and is associated with an excellent long-term prognosis. However until now, Stage III melanoma patients (where the disease has spread to the lymph nodes) who have had their tumours surgically removed have simply had to play the waiting game to see if their melanoma would metastasise, with many ultimately dying of the disease.
Checkpoint inhibitor immunotherapies and drugs that target the mitogen-activated protein kinase (MAPK) pathway have improved the outcome of patients with metastatic melanoma, but their role as adjuvant therapy is still being actively investigated.
Prior Phase III trials (COMBI-D and COMBI-V) have shown improved overall survival in patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations. At Melanoma Institute Australia, we were keen to see if this improvement would be seen in the adjuvant setting also. This clinical trial was the first in the world to give targeted therapy to melanoma patients at an earlier stage of the disease to prevent spread and recurrence.
Prof. Jean Louis MAS[/caption]
Prof. Jean-Louis MAS
Université Paris Descartes
INSERM UMR S 894
Service de Neurologie et Unité Neurovasculaire
Hôpital Sainte-Anne
Paris
MedicalResearch.com: What is the background for this study?
Response: Stroke is a major cause of death, disability and dementia affecting 17 million people each year worldwide. About 80% of strokes are ischemic strokes due to occlusion of a cerebral artery by a thrombus, itself the consequence of various arterial or heart diseases. In 30 to 40% of cases, no definite cause of ischemic stroke can be identified. Cryptogenic stroke is the term used to refer to these strokes of unknown etiology.
The patent foramen ovale (PFO) is a defect between the upper two heart chambers (called atria) though which a thrombus of venous origin may reach the systemic circulation and cause a stroke. This mechanism is called paradoxical embolism. Several case-control studies have shown an association between PFO and cryptogenic ischemic stroke, particularly in patients less than 60 years old, in those who have an atrial septal aneurysm (defined as an abnormal protrusion of the interatrial septum in the right or the left atrium or both) in addition to a PFO, and in those who have a PFO with a large right-to-left shunt. These findings suggested that a PFO might be responsible for stroke and that PFO closure with a device may decrease the risk of stroke recurrence. However, the causative relationship between PFO and stroke and the best strategy to prevent stroke recurrence have long been a hot topic of debate. Three previous randomized clinical trials failed to demonstrate any superiority of PFO closure over antithrombotic therapy.
Dr. Manson[/caption]
JoAnn E. Manson, MD, DrPH
Chief, Division of Preventive Medicine
Brigham and Women's Hospital
Professor of Medicine and the
Michael and Lee Bell Professor of Women's Health
Harvard Medical School
Boston, Massachusetts 02215
MedicalResearch.com: What is the background for this study?
Response: The current report provides new information on total mortality and the rates of death from specific causes (cardiovascular disease, cancer, other major illnesses) over 18 years of follow-up in the Women’s Health Initiative (WHI) randomized trials of hormone therapy (estrogen + progestin and estrogen alone). This is the first WHI report to focus on all-cause and cause-specific mortality. It includes all of the 27,347 women in the 2 hormone therapy trials with >98% follow-up over 18 years, during which time 7,489 deaths occurred. This is more than twice as many deaths as were included in earlier reports. The report also provides detailed information on differences in results by age group (ages 50-59, 60-69, 70-79) at time of study enrollment.
Dr. Farland[/caption]
Leslie V. Farland, ScD
Assistant Director of Epidemiologic Research
Center for Infertility and Reproductive Surgery
Brigham and Women's Hospital | Harvard Medical School
Instructor | Harvard T.H. Chan School of Public Health
MedicalResearch.com: What is the background for this study?
Response: Endometriosis is chronic gynecologic condition that affects approximately ten percent of women. Women with endometriosis can experience painful menstrual periods, general chronic pelvic pain, and pain associated with intercourse. Currently we know very few modifiable risk factors for endometriosis.
Dr. Di Martino[/caption]
Dr. Adriana Di Martino, MD
Associate Professor, Department of Child and Adolescent Psychiatry
NYU Langone Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: While there has been an increased awareness of the co-occurrence of symptoms of Attention Deficit/Hyperactivity Disorder (ADHD) in children with a primary diagnosis of ASD, only recently has there been an appreciation that a substantial proportion of children with ADHD may also have ASD traits. These symptom domains overlap pose a challenge for accurate recognition and targeted treatments, yet their underlying mechanisms have been unknown.
With more traditional diagnostic group comparisons we detected a significant influence of ASD on white matter organization, but our analyses of the severity of symptoms across individuals revealed an association between autistic traits and white matter organization, regardless of the individual's diagnosis. These findings were mostly centered around the corpus callosum, a structure that enables communication between the left and right cerebral hemispheres.
Dr. Papenburg[/caption]
Jesse Papenburg, MD MSc FRCPC
FRQS Clinical Research Scholar
Assistant Professor of Pediatrics, McGill University
Div. of Pediatric Infectious Diseases, Dept. of Microbiology
Montreal Children’s Hospital
Montreal, QC
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Influenza viruses cause yearly epidemics of acute respiratory illness affecting 5 to 30 percent of the population. Diagnosing influenza on the basis of only clinical symptoms is difficult because its manifestations vary and are nonspecific. Reverse transcriptase polymerase chain reaction (RT-PCR) is the gold standard for flu diagnosis, but these tests must be sent to a laboratory and have turnaround times that extend beyond the clinical encounter. Rapid and accurate diagnosis of influenza has the potential to improve patient outcomes and decrease health care costs.
Since 2011, two novel classes of rapid influenza diagnostic assays i.e., with results available in <30 minutes, have been commercialized with claims of improved sensitivities based on technological improvements: 1) automated immunochromatographic antigen detection tests (digital immunoassays, DIAs) and 2) rapid nucleic acid amplification tests (NAATs).
Our systematic review and meta-analysis synthesized the available evidence and compared the diagnostic accuracy of commercially available rapid tests for the detection of influenza A and B infection:
Dr. Xiaoqin Liu[/caption]
Xiaoqin Liu, PhD
Department of Economics and Business Economics
Aarhus University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Previous research on the long-term neurodevelopmental outcomes of serotonin-reuptake inhibitor (SSRI) use during pregnancy has primarily focused on offspring risk of autism spectrum disorder. Given SSRIs cross the placental barrier and affect the fetal brain, in-utero SSRI exposure may increase risks of other psychiatric disorders as well as autism spectrum disorder.
We conducted a population-based study to look at a range of diagnostic groups of psychiatric disorders in children whose mothers used antidepressants during pregnancy. This was possible because of the nature of information available in Danish population registers, allowing us to follow children for many years. We found increased risks of various diagnostic groups of psychiatric disorders in children whose mothers continued antidepressant treatment during pregnancy, in comparison to children whose mothers stopped antidepressant treatment before pregnancy.
Dr. Korgavkar[/caption]
Kaveri Korgavkar, MD
Department of Dermatology
Brown University
Providence, Rhode Island
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Photodamage refers to premature skin aging from long-term UV exposure. Topical fluorouracil cream, typically used in the treatment of actinic keratosis, has been suggested for use in treating photodamage due to clinical and histological findings. However, in our ad hoc secondary analysis of a large randomized clinical trial, a standard course of topical fluorouracil did not result in detectable improvement of photodamage.
Dr. Moreno-Peral[/caption]
Dr. Patricia Moreno-Peral, PhD
Research Unit, Primary Care District of Málaga-Guadalhorce
Prevention and Health Promotion Research Network
Institute of Biomedical Research in Málaga Málaga, Spain
MedicalResearch.com: What is the background for this study?
Response: No systematic reviews or meta-analyses have been performed on the effectiveness of preventive psychological and/or educational interventions for anxiety in varied populations. Previously, other systematic reviews have been focused on prevention efficacy in specific interventions (e.g. cognitive behavior interventions) or age groups (e.g. adolescents).
Mostafavi Hakhamanesh[/caption]
Hakhamanesh Mostafavi, MS
PhD student
Department of Biological Sciences
Columbia University
MedicalResearch.com: What is the background for this study?
Response: We know very little about the genetic variants that underlie adaptation in humans. This is in part because we have mostly been limited to methods that search for footprints of ancient selection (that has acted for over thousands to millions of years) in the genomes of present-day humans; so by design are indirect and make strong assumptions about the nature of selection.
These days, thanks to advances in genomic technologies, genetic data for large numbers of people is being collected, mostly for biomedical purposes. Accompanied by information on survival and reproductive success of these individuals, such large datasets provide unprecedented opportunities for more direct ways to study adaptation in humans.
In this work, we introduced an approach to directly observe natural selection ongoing in humans. The approach consists in searching for mutations that change in frequency with the age of the individuals that carry them, and so are associated with survival. We applied it to around 210,000 individuals from two large US and UK datasets.
Dr. Goessl[/caption]
Mario Goessl, MD, PhD, FACC, FAHA, FESC, FSCAI
Director, Research and Education, Center for Valve and Structural Heart Disease
Director, LAAC/Watchman™ Program
Program Director, Fellowship in Advanced Adult Structural and Congenital Heart Disease Interventions and Interventional Cardiology Fellowship
Minneapolis Heart Institute | Abbott Northwestern Hospital, part of Allina Health
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: We wanted to investigate if asymptomatic patients with severe aortic stenosis benefit clinically from adherence to current national guidelines that suggest close follow up within 6-12 months.
Dr. Jabbour[/caption]
Elias Jabbour, MD
Associate Professor
Leukemia Department
MD Anderson Cancer Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Inotuzumab is active in relapsed or refractory (R/R) acute lymphoblastic leukemia (R/R ALL). The addition of low intensity chemotherapy may further improve outcome.
ORR around 80%. Median survival 11 months. Better results obtained in Savage 1. Superior outcome when compared to historical cohort treated with inotuzumab monotherapy
Dr. Khera[/caption]
Rohan Khera MD
Division of Cardiology
University of Texas Southwestern Medical Center
Texas
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: An increasing number of studies have used administrative claims (or billing) data to study in-hospital cardiac arrest with the goal of understanding differences in incidence and outcomes at hospitals that are not part of quality improvement initiatives like the American Heart Association’s Get With The Guidelines-Resuscitation (AHA’s GWTG-Resuscitation). These studies have important implications for health policies and determining targets for interventions for improving the care of patients with this cardiac arrest, where only in 1 in 5 patient survive the hospitalization.
Therefore, in our study, we evaluated the validity of such an approach. We used data from 56,678 patients in AHA’s GWTG-Resuscitation with a confirmed in-hospital cardiac arrest, which were linked to Medicare claims data. We found:
(1) While most prior studies have used a diagnosis or procedure code alone to identify cases of in-hospital cardiac arrest, we found that the majority of confirmed cases in a national registry (AHA’s GWTG-Resuscitation) would not be captured using either administrative data strategy.
(2) Survival rates using administrative data to identify cases from the same reference population varied markedly and were 52% higher (28.4% vs. 18.7%) when using diagnosis codes alone to identify in-hospital cardiac arrest.
(3) There was large hospital variation in documenting diagnosis or procedure codes for patients with in-hospital cardiac arrest, which would have consequences for using administrative data to examine hospital-level variation in cardiac arrest incidence or survival, or conducting single-center studies to validate this administrative approach.
Dr. Tatham[/caption]
Andrew Tatham, FRCOphth
Consultant Ophthalmologist
Princess Alexandra Eye Pavilion and Department of Ophthalmology
University of Edinburgh, Scotland
MedicalResearch.com: What is the background for this study?
Response: Raised intraocular pressure (IOP) is the major risk factor for the development of glaucoma, the most common cause of irreversible blindness, with lowering IOP the only proven treatment.
Until recently the only way to measure IOP was for patients to visit their clinician meaning it was only possible to obtain a limited number of measurements. This is problematic given that IOP fluctuates and that 75% of individuals have peak IOP outside office hours. If patients could measure their own IOP it would allow far more measurements to be obtained and result in better understanding of the variation and peaks in IOP. This could improve the detection of glaucoma and determine if patients are adequately controlled with medication.
Recently, a patient-operated, home IOP monitoring device (iCare HOME) has become available. The patient holds the device close to their eye and the device automatically determines if it is in the correct position to take a measurement. The tonometer then deploys a small probe which gently bounces off the surface of the eye to determine IOP. As the probe is only in contact with the surface of the eye for a few milliseconds no anesthetic is needed.
Dr. Larsen[/caption]
Ashley Larsen, PhD
Assistant professor
Bren School of Environmental Science & Management
University of California, Santa Barbara
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The relationship between pesticides and adverse birth outcomes has been recognized as an important question for quite some time, and there have been many good studies on the topic. Since randomly exposing people to different levels of pesticides is clearly unethical, researchers focused on the health consequences of non-occupational pesticide exposure often have to choose between detailed studies that follow a couple hundred or couple thousand individuals through pregnancy or larger scale studies that use easier to observe, but less accurate metrics of pesticide exposure (e.g. nearby crops or crop types). Here we tried to provide complementary insight by bridging the gap between detail and scale using detailed pesticide use data and individual birth certificate records for hundreds of thousands of births in an agriculturally dominated region of California. While we found negative effects of pesticide use on birth outcomes including low birth weight, preterm birth and birth abnormalities, these effects were generally in the magnitude of a 5-9% increase in probability of an adverse outcome, and only observed for individuals exposed to very high levels of pesticides.
Dr. Bloss[/caption]
Cinnamon S. Bloss, Ph.D.
Associate Professor, Department of Psychiatry
Department of Family Medicine and Public Health
Division of Health Policy
University of California, San Diego
MedicalResearch.com: What is the background for this study?
Response: In 2016, the FDA invited public comments on a draft environmental assessment for a proposed field trial of a genetically modified (GM) mosquito designed to suppress wild-type Aedes aegypti mosquitoes. The preliminary finding from the environmental assessment indicated the trial would be unlikely to adversely affect the environment in Key Haven, Florida, the proposed trial site. We assessed public response to this trial based on the content of public comments submitted to the FDA by requesting comment transcripts through the Freedom of Information Act.