tbuckley/cabot-search huggingface dataset:
Unmanipulated haploidentical in comparison with matched unrelated donor stem cell transplantation in patients 60 years and older with acute myeloid leukemia: a comparative study on behalf of the ALWP of the EBMT
Authors: Nicole Santoro, Myriam Labopin, Federica Giannotti, Gerard Ehninger, Dietger Niederwieser, Arne Brecht, Matthias Stelljes, Nicolaus Kröger, Herman Einsele, Matthias Eder, Michael Hallek, Bertram Glass, Jürgen Finke, Fabio Ciceri, Mohamad Mohty, Annalisa Ruggeri, Arnon Nagler
Journal: Journal of Hematology & Oncology (2018)

Acute myeloid leukemia (AML) is both more common and with more biologically aggressive phenotype in the elderly. Allogenic stem cell transplantation (allo-SCT) is the best treatment option in fit patients. Either HLA-matched unrelated donor (MUD) or haploidentical (Haplo) donor are possible alternative for patients in need.We retrospectively compared non-T-cell-depleted Haplo (n = 250) to 10/10 MUD (n = 2589) in AML patients ≥ 60 years.Median follow-up was 23 months. Disease status at transplant differs significantly between the two groups (p < 10-4). Reduced intensity conditioning (RIC) was administrated to 73 and 77% of Haplo and MUD, respectively (p = 0.23). Stem cell source was the bone marrow (BM) in 52% of the Haplo and 6% of MUD (p < 10-4). Anti-thymocyte globulin (ATG) was most frequently used in MUD (p < 10-4) while post-Tx cyclophosphamide (PT-Cy) was given in 62% of Haplo. Engraftment was achieved in 90% of the Haplo vs 97% of MUD (p < 10-4). In multivariate analysis, no significant difference was found between Haplo and MUD for acute (a)graft versus host disease (GVHD) grade II-IV, relapse incidence (RI), non-relapse mortality (NRM), leukemia free survival (LFS), graft-versus-host-free-relapse free survival (GRFS), and overall survival (OS). Extensive chronic (c)GVHD was significantly higher for MUD as compared to Haplo (HR 2, p = 0.01, 95% CI 1.17-3.47). A propensity score analysis confirmed the higher risk of extensive cGVHD for MUD without differences for other outcomes.Allo-SCT from both Haplo and MUD are valid option for AML patients ≥ 60 years of age with similar results. Transplantation from MUD was associated with higher extensive cGVHD. Our findings suggest that Haplo is a suitable and attractive graft source for patients≥ 60 with AML in need of allo-SCT.
Author Correction: Global evidence of extreme intuitive moral prejudice against atheists
Authors: Will M. Gervais, Dimitris Xygalatas, Ryan T. McKay, Michiel van Elk, Emma E. Buchtel, Mark Aveyard, Sarah R. Schiavone, Ilan Dar-Nimrod, Annika M. Svedholm-Häkkinen, Tapani Riekki, Eva Kundtová Klocová, Jonathan E. Ramsay, Joseph Bulbulia
Journal: Nature Human Behaviour (2018)
In hepatitis C patients with cirrhosis who achieve SVR with treatment, reduction in transient elastography measures does not translate to reduced risk of hepatocellular carcinoma: A prospective cohort study
Authors: J. Howell, T. Papaluca, S. Glasgow, K. New, T. Hong, J. Snell, D. Iser, M. Ryan, S. Bell, P. Desmond, S.L.C.Y. Mei, C. Croagh, T. Nguyen, Z. Valaydon, G. Shaw, B. Demediuk, L. Mcdonald, A. Craigie, L. Stothers, M. Lust, C. Jeremiah, K. Visvanathan, A. Thompson
Journal: Journal of Hepatology (2018)
Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis
Authors: Eleni Bekiari, Konstantinos Kitsios, Hood Thabit, Martin Tauschmann, Eleni Athanasiadou, Thomas Karagiannis, Anna-Bettina Haidich, Roman Hovorka, Apostolos Tsapas
Journal: BMJ (2018)

To evaluate the efficacy and safety of artificial pancreas treatment in non-pregnant outpatients with type 1 diabetes.
Platelet Count Affects Efficacy of Folic Acid in Preventing First Stroke
Authors: Xiangyi Kong, Xiao Huang, Min Zhao, Benjamin Xu, Richard Xu, Yun Song, Yaren Yu, Wenbin Yang, Jingping Zhang, Lishun Liu, Yan Zhang, Genfu Tang, Binyan Wang, Fan Fan Hou, Ping Li, Xiaoshu Cheng, Shuiping Zhao, Xiaobin Wang, Xianhui Qin, Jianping Li, Yong Huo
Journal: Journal of the American College of Cardiology (2018)
Strong intrahepatic decline of hepatitis D virus RNA and antigen after 24 weeks of treatment with Myrcludex B in combinationwith Tenofovir in chronic HBV/HDV infected patients: Interim results from a multicenter, open-label phase 2b clinical trial
Authors: L. Allweiss, C. Dettmer, T. Volz, K. Giersch, A. Alexandrov, H. Wedemeyer, S. Urban, J.-H. Bockmann, M. Luetgehmann, M. Dandri
Journal: Journal of Hepatology (2018)
Firm Papules and Nodules on Face, Neck, and Thorax
Authors: Zhong-Shuai Wang, Jun Li
Journal: JAMA Dermatology (2018)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Dermatology HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Dermatology journal
A phase 2 study of s-1 plus leucovorin in patients with untreated advanced cholangiocarcinoma (CCA).
Authors: Suebpong Tanasanvimon, Teerapat Ungtrakul, Nattaya Poovorawan, Napa Parinyanitikul, Chanida Vinayanuwattikun, Siyamol Mingmalairak, Sutima Luangdilok, Wisut Lamlertthon, Virote Sriuranpong
Journal: Journal of Clinical Oncology (2018)

467 Background: Patients with CCA usually present with advanced disease leading to the grave prognosis. Currently, cisplatin and gemcitabine is the standard treatment in advanced CCA. However, the CCA treatment outcomes are still poor and the options of treatment are quite limited. This study aimed to explore the efficacy and safety of S-1 plus leucovorin in patients with untreated advanced CCA. Methods: This single-arm two-center phase 2 study evaluated the efficacy and safety of S-1 40, 50 and 60 mg according to body surface area and leucovorin 15 mg , both given orally twice daily for one week, repeated every two weeks. Treatment was continued until complete 12 cycles, disease progression or unacceptable toxicity. The primary endpoints were overall response rate (ORR) and disease control rate (DCR) per RECIST version 1.1. The secondary endpoints were progression free survival (PFS), overall survival (OS) and toxicity. Results: Of total 32 patients and a median follow up time of 9.5 months, the ORR was 25% (95%CI 9.1-40.9) and the DCR was 62.5% (95% CI 44.8-80.2). In 25 response evaluable patients, the ORR was 32% (95% CI 12.4-51.7). The PFS was 8.0 (95%CI 5.59-10.4) months. The OS was 11.0 (95%CI 9.47-12.53). The most common grade 3 or 4 toxicities were anemia, mucositis and diarrhea. There was one patient discontinuing treatment due to treatment related toxicity. Conclusions: S-1 plus leucovorin was active and tolerable in patients with advanced CCA. Clinical trial information: TCTR20160313001.
Consecutive negative findings on colonoscopy during surveillance predict a low risk of advanced neoplasia in patients with inflammatory bowel disease with long-standing colitis: results of a 15-year multicentre, multinational cohort study
Authors: Joren R ten Hove, Shailja C Shah, Seth R Shaffer, Charles N Bernstein, Daniel Castaneda, Carolina Palmela, Erik Mooiweer, Jordan Elman, Akash Kumar, Jason Glass, Jordan Axelrad, Thomas A Ullman, Jean-Frederic Colombel, Joana Torres, Adriaan A van Bodegraven, Frank Hoentjen, Jeroen M Jansen, Michiel E de Jong, Nofel Mahmmod, Andrea E van der Meulen-de Jong, Cyriel Y Ponsioen, Christine J van der Woude, Steven H Itzkowitz, Bas Oldenburg
Journal: Gut (2018)

Objectives Surveillance colonoscopy is thought to prevent colorectal cancer (CRC) in patients with long-standing colonic IBD, but data regarding the frequency of surveillance and the findings thereof are lacking. Our aim was to determine whether consecutive negative surveillance colonoscopies adequately predict low neoplastic risk. Design A multicentre, multinational database of patients with long-standing IBD colitis without high-risk features and undergoing regular CRC surveillance was constructed. A ‘negative’ surveillance colonoscopy was predefined as a technically adequate procedure having no postinflammatory polyps, no strictures, no endoscopic disease activity and no evidence of neoplasia; a ‘positive’ colonoscopy was a technically adequate procedure that included at least one of these criteria. The primary endpoint was advanced colorectal neoplasia (aCRN), defined as high-grade dysplasia or CRC. Results Of 775 patients with long-standing IBD colitis, 44% (n=340) had &gt; 1 negative colonoscopy. Patients with consecutive negative surveillance colonoscopies were compared with those who had at least one positive colonoscopy. Both groups had similar demographics, disease-related characteristics, number of surveillance colonoscopies and time intervals between colonoscopies. No aCRN occurred in those with consecutive negative surveillance, compared with an incidence rate of 0.29 to 0.76/100 patient-years (P=0.02) in those having &gt; 1 positive colonoscopy on follow-up of 6.1 (P25–P75: 4.6–8.2) years after the index procedure. Conclusion Within this large surveillance cohort of patients with colonic IBD and no additional high-risk features, having two consecutive negative colonoscopies predicted a very low risk of aCRN occurrence on follow-up. Our findings suggest that longer surveillance intervals in this selected population may be safe.
Assessment of biventricular function in patients with decompensated cirrhosis and hepatopulmonary syndrome
Authors: S. Soulaidopoulos, M. Vlachou, T. Oikonomou, T. Tzoumari, P. Doumtsis, A. Karasmani, G. Giannakoulas, H. Karvounis, E. Cholongitas, I. Goulis
Journal: Journal of Hepatology (2018)
The Short-Lived Epidemic of Botulism From Commercially Canned Foods in the United States, 1919 to 1925
Authors: Powel Kazanjian
Journal: Annals of Internal Medicine (2018)

In 1919, three deadly outbreaks of botulism caused by consumption of canned olives packed in California captured national headlines. In all of the outbreaks, which occurred in separate locales, unsuspecting people died after consuming tainted food during a banquet or family meal. The press's sensational portrayal of canned food as hazardous aroused alarm among consumers at a time when commercial canning was becoming more common. Intent on restoring the image of their product as safe and wholesome, canning industry leaders funded a "botulism commission" of scientific experts in 1919 to investigate how to systematically eliminate the threat of botulism that had imperiled their business. The commissioners identified the scientific reasons for the outbreaks, and on the basis of their findings, the California Department of Public Health issued explicit recommendations for sterilization procedures intended to ensure safety. However, the department did not mandate inspections for all canneries. When commercially packed fruits and vegetables continued to cause botulism, industry leaders voluntarily backed a cannery inspection act to legally require all California canners to possess appropriate equipment and follow scientifically validated sterilization procedures. After the California legislature approved the act in 1925, canneries were inspected, regulations were enforced, and no further outbreaks occurred. This botulism epidemic is an example of a disease outbreak that was controlled when business interests became aligned with public health goals. The press's portrayal of afflicted persons as innocent victims and worthy citizens galvanized businessmen to implement safeguards to protect consumers from botulism intoxication. To preserve their customer base and salvage their corporations, leaders of the canning industry acknowledged the public health threat of their unregulated procedures and acted on the recommendations of scientists.
Abstract 18225: The Role of Computed Tomography and Magnetic Resonance Imaging in the Diagnosis of Perivalvular Complications and Myocardium Infiltration in Infectious Endocarditits
Authors: Karina Zatorska, Ilona Michalowska, Elzbieta Abramczuk, Dariusz Zakrzewski, Mariusz Kusmierczyk, Tomasz Hryniewiecki
Journal: Circulation (2017)

Introduction:  Echocardiography - transthoracic (TTE) and/or transesophageal (TEE) remains the gold standard for the diagnosis of infective endocarditis (IE).   Aim of the study:  To assess the usefulness of cardiac computed tomography and cardiac magnetic resonance in patients with infective endocarditis.   Methods:  The study included 79 consecutive patients with IE. Each patient underwent TTE and TEE. Cardiac computed tomography (CT) was performed in 71 patients. Cardiac magnetic resonance (CMR) imaging was performed in 20 patients. Fifty-nine patients were qualified for surgical treatment.   Results:  Among the patients who underwent CT, 53 were operated. In this group, intraoperative assessment revealed the presence of 11 abscesses/pseudoaneurysms. The combination of CT and echocardiography allowed all abscesses to be diagnosed. Inflammatory infiltration was found intraoperatively in 15 patients. The analysis of total TEE and CT findings showed that supplementing echocardiography with CT had increased the sensitivity of the method for detecting inflammatory infiltration to 76%.The sensitivity of TEE in the diagnosis of cusp perforation, perivalvular leakage and vegetation was higher than CT. CMR revealed vegetations in 15 patients, at echocardiography vegetations were found in 19 patients. Valve perforation was suspected in seven patients at echocardiography, and in six of these patients after CMR. In one patient after Bentall procedure, an inflammatory infiltration was seen around the prosthesis both at CMR and echocardiography. Among the 20 patients who underwent the CMR, the foci of late gadolinium enhancement (LGE) were found in 8 cases. The foci were identified in the interventricular septum, left ventricle walls and, in the case of the patient after Bentall procedure, around the aortic prosthesis. The foci were more common in patients with aortic valve IE.   Conclusions:  1.Cardiac computed tomography examination is useful in the diagnosis of infective endocarditis and its local complications. 2.Magnetic resonance imaging may serve as a useful method for evaluating the degree of inflammatory process involvement in the myocardium.
Unsolicited Diagnosis of Mental Disorder: Epistemic and Normative Perspectives
Authors: Gustav Preller, Anna-Henrikje Seidlein, Sabine Salloch
Journal: The American Journal of Bioethics (2018)

"Unsolicited Diagnosis of Mental Disorder: Epistemic and Normative Perspectives." The American Journal of Bioethics, 18(5), pp. 34–35
Enhanced liver fibrosis test predicts liver-related outcomes in postmenopausal women with risk factors in the community
Authors: P. Trembling, S. Apostolidou, A. Gentry-Maharaj, J. Parkes, A. Ryan, S. Tanwar, M. Burnell, S. Harris, U. Menon, W. Rosenberg
Journal: Journal of Hepatology (2018)
Erythematous Plaque on the Inferior Eyelid
Authors: Laura Z. Costamilan, Felipe B. Cerci, Betina Werner
Journal: JAMA Dermatology (2018)

A 40-year-old woman presented with an 8-year history of a growing erythematous plaque on the left lower eyelid; physical examination revealed a single plaque involving the left lower eyelid, including its border, and eyelashes were absent. What is your diagnosis?
NanoSIMS Analysis of Intravascular Lipolysis and Lipid Movement across Capillaries and into Cardiomyocytes
Authors: Cuiwen He, Thomas A. Weston, Rachel S. Jung, Patrick Heizer, Mikael Larsson, Xuchen Hu, Christopher M. Allan, Peter Tontonoz, Karen Reue, Anne P. Beigneux, Michael Ploug, Andrea Holme, Matthew Kilburn, Paul Guagliardo, David A. Ford, Loren G. Fong, Stephen G. Young, Haibo Jiang
Journal: Cell Metabolism (2018)
The global prevalence of HBsAg by age in 2016 and the case for universal treatment in low and middle income countries
Authors: D. Razavi-Shearer, I. Gamkrelidze, S. Blach, S. Brandon, C. Estes, H. Nde, S. Robbins, J. Schmelzer, H. Razavi
Journal: Journal of Hepatology (2018)
Type 2 Diabetes in Relation to the Risk of Renal Cell Carcinoma Among Men and Women in Two Large Prospective Cohort Studies
Authors: Rebecca E. Graff, Alejandro Sanchez, Deirdre K. Tobias, Dayron Rodríguez, Glen W. Barrisford, Michael L. Blute, Yanping Li, Qi Sun, Mark A. Preston, Kathryn M. Wilson, Eunyoung Cho
Journal: Diabetes Care (2018)

OBJECTIVE We assessed whether type 2 diabetes is associated with renal cell carcinoma (RCC), independent of key potential confounders, in two large prospective cohorts with biennially updated covariate data. RESEARCH DESIGN AND METHODS A total of 117,570 women from the Nurses’ Health Study (NHS) and 48,866 men from the Health Professionals Follow-Up Study (HPFS) were followed from 1976 and 1986, respectively, through 2014. Multivariable Cox proportional hazards models were used to calculate hazard ratios (HRs) and 95% CIs for associations between type 2 diabetes and pathology-confirmed RCC, overall and by stage, grade, and histologic subtype. RESULTS During 38 years of follow-up in the NHS, we confirmed 418 RCC case subjects, including 120 fatal cases. Over 28 years in the HPFS, we confirmed 302 RCC case subjects, including 87 fatal cases. Women with type 2 diabetes had a significantly increased risk of RCC compared with women without type 2 diabetes (multivariable HR 1.53; 95% CI 1.14–2.04), with some evidence that the association was stronger for ≤5 (HR 2.15; 95% CI 1.44–3.23) than &amp;gt;5 (HR 1.22; 95% CI 0.84–1.78) years’ duration of type 2 diabetes (Pdifference 0.03). Among men, type 2 diabetes was not associated with total RCC (HR 0.89; 95% CI 0.56–1.41) or with RCC defined by stage, grade, or subtype. Sample sizes for analyses by stage, grade, and subtype were limited. CONCLUSIONS We found that type 2 diabetes was independently associated with a greater risk of RCC in women but not in men.
Obeticholic acid, a FXR agonist, inhibits the cancerogenic potential of primary human cholangiocarcinoma (CCA) cells cultures
Authors: S.D. Matteo, L. Nevi, D. Constantini, M. Colantonio, F. Giulitti, C. Napoletano, S. Safarikia, E. Manzi, A.M.D. Rose, F. Melandro, M. Bragazzi, P.B. Berloco, F. Giuliante, G. Carpino, V. Cardinale, E. Gaudio, D. Alvaro
Journal: Journal of Hepatology (2018)
In hospitalized adults with polypharmacy, a multifaceted pharmacist intervention reduced readmissions at 180 days
Authors: Sharon E. Straus, Lisa Dolovich
Journal: Annals of Internal Medicine (2018)

Source Citation Ravn-Nielsen LV, Duckert ML, Lund ML, et al. Effect of an in-hospital multifaceted clinical pharmacist intervention on the risk of readmission: a randomized clinical trial. JAMA Intern Med. 2018;178:375-82. 29379953
<i>ERJ</i>30 years: establishment and early years
Authors: Erik Berglund
Journal: European Respiratory Journal (2018)

During the 1960s and 1970s, we had in Europe an abundance of respiratory journals. They were national, or sponsored by pharmaceutical companies, or produced by private publishing companies. At the time, they could not compete with the journals published in North America. Three respiratory journals in Europe were merged in two steps to form the ERJ <http://ow.ly/qaqk30jxg0Q>
The Mediterranean Diet’s Fight Against Frailty
Authors: Rebecca Voelker
Journal: JAMA (2018)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors Podcasts Clinical Reviews Editors' Summary Medical News Author Interviews More Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal
M2 macrophage specfifc gene silencing in the liver using third generations mannose coated, siRNA-loaded nanohydrogel particles
Authors: L. Kaps, N. Leber, A. Yang, M. Giardino, S. Rizelli, M. Aslam, A. Mostafa, R. Zentel, D. Schuppan
Journal: Journal of Hepatology (2018)
Cabazitaxel in patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy: Results of a phase II trial—CAB-B1.
Authors: Anjali Zarkar, Andrea Marshall, Janet Dunn, Amanda Davies, Daniel Ford, Nicholas D. James
Journal: Journal of Clinical Oncology (2017)

4542 Background: There is a paucity of chemotherapy options for the treatment of patients who have relapsed following platinum based chemotherapy (CT). Cabazitaxel is a new taxane that showed in-vivo antiproliferative activity on resistant cell lines. Methods: CAB-B1 was a single centre phase II randomised controlled trial of Cabazitaxel (CAB; 25mg/m 2 q3 week for 6 cycles) versus best supportive care (BSC) in patients (pts) with histologically proven transitional cell carcinoma (TCC), locally advanced or metastatic, who had received platinum based treatment and recurred within 12 months of the last cycle of CT. Primary outcome was overall response rate (ORR) using RESIST. Secondary outcomes were Progression Free Survival (PFS), Overall Survival (OS), Quality of Life assessment, safety and tolerability. A total of 96 pts required to detect differences in ORR from 5% to 30%; 80% power; 5% alpha level; 10% dropouts. Stopping rules, using Simon’s two stage optimal design to assess the individual effectiveness of CAB, required at least 1 ORR from 10 pts on CAB during 1 st stage (i.e. total of 20 pts randomised) and 4 from 29 CAB pts in 2 nd stage (assuming lower ORR limit of 0.05, target ORR of 0.20, 80% power, 5% alpha level). The trial was supported by grant from Sanofi. Results: Between January 2013 and October 2016, 20 pts were randomised (10 on each arm). 75% males; median age 68 years; 65% had recurred within 6 months of previous CT. BSC included paclitaxel CT for 9 pts and radiotherapy for 1 pt. 8 pts completed 6 cycles of CT (3 on CAB; 5 on BSC). 6 pts on each arm were evaluated for response after having 2/3 cycles; 2 pts had an ORR on CAB and 1 pt on BSC. 14 pts have died of disease (8 on CAB; 6 on BSC).Median OS was 5.6 months (95% confidence interval (CI) 0.7-15.2) for CAB pts and 8.2 months (95% CI 1.0-8.8) for BSC pts. Median PFS was 4.4 months (95% CI 0.7-9.4) for CAB pts and 4.1 months (95% CI 1.0-6.8) for BSC pts. Conclusions: It has been hard to recruit these poorly patients within a single centre, but CAB-B1 successfully reached the efficacy target for the 1 st stage, showing that there could be a role for CAB in these pts. Clinical trial information: NCT01668459.