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  • SAGE Publications  (74)
  • 1
    Online Resource
    Online Resource
    Real-world outcomes of adjuvant gemcitabine versus gemcitabine plus capecitabine for resected pancreatic ductal adenocarcinoma
    SAGE Publications ; 2022
    In:  Therapeutic Advances in Medical Oncology Vol. 14 ( 2022-01), p. 175883592210971-
    Details
    In: Therapeutic Advances in Medical Oncology, SAGE Publications, Vol. 14 ( 2022-01), p. 175883592210971-
    Abstract: Adjuvant chemotherapy is the standard treatment after curative-intent surgery for pancreatic ductal adenocarcinoma (PDAC). The phase-3 ESPAC-4 trial demonstrated significantly improved overall survival (OS) with Gemcitabine plus capecitabine (GemCap) over Gemcitabine (Gem) in Europe. We conducted a retrospective efficacy and safety evaluation of GemCap versus Gem in an Asian population. Methods: This retrospective analysis included 292 patients with PDAC who received adjuvant Gem or GemCap after curative resection between January 2017 and December 2020 at Asan Medical Center, Seoul, Korea. Results: Adjuvant Gem and GemCap were administered to 161 (55.1%) and 131 (44.8%) patients, respectively. The Gem group had significantly older patients (median 66 versus 63 years, p = 0.001); otherwise, the groups had similar baseline characteristics. With median follow-up durations of 39.4 [95% confidence interval (CI), 36.9–45.0] and 39.4 (95% CI, 34.7–41.6) months in the Gem and GemCap groups, the median OS was 36. 8 (95% CI, 29.7–43.5) and 46.1 (95% CI, 31.5–not reached) months in the Gem and GemCap groups, respectively [unadjusted hazard ratio (HR) = 0.7; 95% CI, 0.5–1.0; p = 0.07). The median recurrence-free survival was 14.3 (95% CI, 12.9–17.7) and 17.0 (95% CI, 13.3–28.2) months, respectively ( p = 0.5). Hand-foot skin reactions (any grade, 15.3% versus 0.6%; p  〈  0.001), neutropenia (78.6% versus 67.7%, p = 0.04) and thrombocytopenia (30.5% versus 20.5%, p = 0.04) were more common in the GemCap group. Multivariate analysis revealed adjuvant GemCap – compared with Gem – to be significantly associated with better OS (adjusted HR = 0.6; 95% CI, 0.4–0.9; p = 0.01). Otherwise, moderate or poor histological grade, lymph node positivity, positive resection margin, and elevated CA 19-9 ( 〉 median) were significantly associated with worse OS. Conclusions: Adjuvant GemCap showed the consistent clinical outcomes with the ESPAC-4 trial. As mFOLFIRINOX is the new standard treatment for medically fit patients with resected PDAC, further evaluation of optimal adjuvant chemotherapy in daily practice is warranted.
    Type of Medium: Online Resource
    ISSN: 1758-8359 , 1758-8359
    URL: Article
    DOI: 10.1177/17588359221097190
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2503443-1
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  • 2
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    FOLFIRINOX in borderline resectable and locally advanced unresectable pancreatic adenocarcinoma
    SAGE Publications ; 2020
    In:  Therapeutic Advances in Medical Oncology Vol. 12 ( 2020-01), p. 175883592095329-
    Details
    In: Therapeutic Advances in Medical Oncology, SAGE Publications, Vol. 12 ( 2020-01), p. 175883592095329-
    Abstract: Despite the scarcity of data based on randomized trials, FOLFIRINOX is widely used in the management of borderline resectable pancreatic cancer (BRPC) and locally advanced unresectable pancreatic cancer (LAPC). We investigated the clinical outcomes of neoadjuvant FOLFIRINOX in patients with BRPC and LAPC. Methods: This single-center retrospective analysis included a total of 199 consecutive patients with BRPC or LAPC who received conventional or modified FOLFIRINOX between February 2013 and January 2017. An independent radiologist reviewed all baseline computed tomography or magnetic resonance imaging scans were reviewed for vascular invasion status. Results: With median follow-up duration of 40.3 months [95% confidence interval (CI), 36.7–43.8] in surviving patients, median progression-free survival (PFS) and overall survival (OS) were 10.6 (95% CI, 9.5–11.7) and 18.1 (95% CI, 16.0–20.3) months, respectively. The 1-year PFS rate was 66.0% (95% CI, 65.3–66.7%), and the 2-year OS rate was 37.2% (95% CI, 36.5–37.9%). PFS and OS did not differ between BRPC and LAPC groups [median PFS, 11.1 months (95% CI, 8.8–13.5) versus 10.1 months (95% CI, 8.4–11.8), p = 0.47; median OS, 18.4 months (95% CI, 16.1–20.8) versus 17.1 months (95% CI, 13.2–20.9), p = 0.50] . Curative-intent conversion surgery (R0/R1) was performed in 63 patients (31.7%). C•A 19-9 response, objective tumor response to FOLFIRINOX, and conversion surgery were independent prognostic factors for OS. Conclusion: FOLFIRINOX was effective for management of BRPC and LAPC. Given the potential for cure, a significant proportion of patients can undergo conversion curative-intent surgery following FOLFIRINOX.
    Type of Medium: Online Resource
    ISSN: 1758-8359 , 1758-8359
    URL: Article
    DOI: 10.1177/1758835920953294
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2503443-1
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  • 3
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    Prognostic implications of hepatitis B virus infection in intrahepatic cholangiocarcinoma treated with first-line gemcitabine plus cisplatin
    SAGE Publications ; 2018
    In:  The International Journal of Biological Markers Vol. 33, No. 4 ( 2018-11), p. 432-438
    Details
    In: The International Journal of Biological Markers, SAGE Publications, Vol. 33, No. 4 ( 2018-11), p. 432-438
    Abstract: Hepatitis B virus infection is a well-known risk factor for intrahepatic cholangiocarcinoma. However, its prognostic impact has rarely been investigated in advanced intrahepatic cholangiocarcinoma. Methods: Between April 2010 and May 2015, 296 patients with unresectable or metastatic intrahepatic cholangiocarcinoma who received gemcitabine plus cisplatin (GemCis) were categorized into a hepatitis B virus group (n=62; 21%) and a non-hepatitis B virus group (n=234; 79%). Clinicopathological features and survival outcomes were retrospectively reviewed and analyzed. Results: The median age of patients was 59 years (range, 27–78). The median overall survival with first-line GemCis was 9.4 months (95% CI 8.4, 10.4). Compared to the non-hepatitis B virus group, the hepatitis B virus group was younger (median age, 57 vs. 61 years, P = 0.001), mainly male (74% vs. 57%, P = 0.02), and had lower frequency of elevated cancer antigen (CA) 19-9 (34% vs. 59%, P = 0.001) and alkaline phosphatase (43% vs. 61%, P = 0.01). In a univariate analysis, the hepatitis B virus infection showed a marginal relationship with poor overall survival compared to the non-hepatitis B virus infection (median, 8.3 vs. 10.0 months; P=0.13). A multivariate analysis of potential prognostic factors revealed a significant association with poor overall survival in the hepatitis B virus group (hazard ratio (HR) =1.50, P = 0.02). Initial metastatic disease (vs. recurrent/unresectable disease; HR=1.50), metastatic sites ⩾ 2 (vs. 0–1; HR=1.51), Eastern Cooperative Oncology Group performance status ⩾ 2 (vs. 0–1; HR=1.93), elevated total bilirubin (vs. normal; HR=1.83), and low albumin (vs. normal; HR=1.52) were significantly related to an unfavorable overall survival. Conclusions: This study suggests that the hepatitis B virus infection may be associated with distinctive clinicopathological characteristics and poor outcome in advanced intrahepatic cholangiocarcinoma treated with GemCis.
    Type of Medium: Online Resource
    ISSN: 1724-6008 , 1724-6008
    URL: Article
    DOI: 10.1177/1724600818777239
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
    detail.hit.zdb_id: 1475778-3
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  • 4
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    Optimal biliary access point and learning curve for endoscopic ultrasound-guided hepaticogastrostomy with transmural stenting
    SAGE Publications ; 2017
    In:  Therapeutic Advances in Gastroenterology Vol. 10, No. 1 ( 2017-01), p. 42-53
    Details
    In: Therapeutic Advances in Gastroenterology, SAGE Publications, Vol. 10, No. 1 ( 2017-01), p. 42-53
    Abstract: Although endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) with transmural stenting has increased for biliary decompression in patients with an inaccessible papilla, the optimal biliary access point and the learning curve of EUS-HGS have not been studied. We evaluated the optimal biliary access point and learning curve for technically successful EUS-HGS. Methods: 129 consecutive patients (male n = 81, 62.3%; malignant n = 113, 87.6%) who underwent EUS-HGS due to an inaccessible papilla were enrolled. EUS finding and procedure times according to each needle puncture attempt in EUS-HGS were prospectively measured. Learning curves of EUS-HGS were calculated for two main outcome measurements (procedure time and adverse events) by using the moving average method and cumulative sum (CUSUM) analysis, respectively. Results: A total of 174 EUS-HGS attempts were performed in 129 patients. The mean number of needle punctures was 1.35 ± 0.57. Using the logistic regression model, bile duct diameter of the puncture site ⩽ 5 mm [odds ratio (OR) 3.7, 95% confidence interval (CI): 1.71–8.1, p 〈 0.01] and hepatic portion length [linear distance from the mural wall to the punctured bile duct wall on EUS; mean hepatic portion length was 27 mm (range 10–47 mm)] 〉 3 cm (OR 5.7, 95% CI: 2.7–12, p 〈 0.01) were associated with low technical success. Procedure time and adverse events were shorter after 24 cases, and stabilized at 33 cases of EUS-HGS, respectively. Conclusions: Our data suggest that a bile duct diameter 〉 5 mm and hepatic portion length 1 cm to ⩽ 3 cm on EUS may be suitable for successful EUS-HGS. In our learning curve analysis, over 33 cases might be required to achieve the plateau phase for successful EUS-HGS.
    Type of Medium: Online Resource
    ISSN: 1756-2848 , 1756-2848
    URL: Article
    DOI: 10.1177/1756283X16671671
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
    detail.hit.zdb_id: 2440710-0
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  • 5
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    Dual antiplatelet Use for extended period taRgeted to AcuTe ischemic stroke with presumed atherosclerotic OrigiN (DURATION) trial: Rationale and design
    SAGE Publications ; 2023
    In:  International Journal of Stroke Vol. 18, No. 8 ( 2023-10), p. 1015-1020
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 18, No. 8 ( 2023-10), p. 1015-1020
    Abstract: The optimal duration of dual antiplatelet therapy (DAPT) with clopidogrel-aspirin for the large artery atherosclerotic (LAA) stroke subtype has been debated. Aims: To determine whether the 1-year risk of recurrent vascular events could be reduced by a longer duration of DAPT in patients with the LAA stroke subtype. Methods and study design: A total of 4806 participants will be recruited to detect a statistically significant relative risk reduction of 22% with 80% power and a two-sided alpha error of 0.05, including a 10% loss to follow-up. This is a registry-based, multicenter, prospective, randomized, open-label, blinded end point study designed to evaluate the efficacy and safety of a 12-month duration of DAPT compared with a 3-month duration of DAPT in the LAA stroke subtype. Patients will be randomized (1:1) to either DAPT for 12 months or DAPT for 3 months, followed by monotherapy (either aspirin or clopidogrel) for the remaining 9 months. Study outcomes: The primary efficacy outcome of the study is a composite of stroke (ischemic or hemorrhagic), myocardial infarction, and all-cause mortality for 1 year after the index stroke. The secondary efficacy outcomes are (1) stroke, (2) ischemic stroke or transient ischemic attack, (3) hemorrhagic stroke, and (4) all-cause mortality. The primary safety outcome is major bleeding. Discussion: This study will help stroke physicians determine the appropriate duration of dual therapy with clopidogrel-aspirin for patients with the LAA stroke subtype. Trial registration: URL: https://cris.nih.go.kr/cris . CRIS Registration Number: KCT0004407
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930231168742
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2211666-7
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  • 6
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    Optimal use of antithrombotic agents in ischemic stroke with atrial fibrillation and large artery atherosclerosis
    SAGE Publications ; 2023
    In:  International Journal of Stroke Vol. 18, No. 7 ( 2023-08), p. 812-820
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 18, No. 7 ( 2023-08), p. 812-820
    Abstract: Optimal antithrombotic regimens to prevent recurrent stroke in patients with ischemic stroke due to atrial fibrillation (AF) and atherosclerotic large-vessel stenosis remain unknown. Aims: This study aimed to evaluate the effect of multiple antithrombotic therapies on outcomes at 1 year after ischemic stroke due to two or more causes. Methods: We identified 862 patients with ischemic stroke due to AF and large artery atherosclerosis from the linked data. These patients were categorized into three groups according to antithrombotic therapies at discharge: (1) antiplatelets, (2) oral anticoagulants (OAC), and (3) antiplatelets plus OAC. The study outcomes were recurrent ischemic stroke, composite outcomes for cardiovascular events, and major bleeding after 1 year. Inverse probability of treatment weighting (IPTW) was used to balance the three groups using propensity scores. Results: Among 862 patients, 169 (19.6%) were treated with antiplatelets, 405 (47.0%) were treated with OAC, and 288 (33.4%) were treated with antiplatelets and OAC. After applying IPTW, only OAC had a significant beneficial effect on the 1-year composite outcome (hazard ratio (HR): 0.37, 95% confidence interval (CI): 0.23–0.60, p  〈  0.001) and death (HR: 0.35, 95% CI: (0.19–0.63), p  〈  0.001). The combination of antiplatelet agents and OAC group had an increased risk of major bleeding complications (HR: 5.27, 95% CI: (1.31–21.16), p = 0.019). However, there was no significant difference in 1-year recurrent stroke events among the three groups. Conclusion: This study demonstrated that OAC monotherapy was associated with lower risks of composite outcome and death in patients at 1 year after ischemic stroke due to AF and atherosclerotic stenosis. In addition, the combination of an antiplatelet and OAC had a high risk of major bleeding.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930231158211
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
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  • 7
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    Outcome in Patients Treated with Intra-arterial thrombectomy: The optiMAL Blood Pressure control (OPTIMAL-BP) Trial
    SAGE Publications ; 2022
    In:  International Journal of Stroke Vol. 17, No. 8 ( 2022-10), p. 931-937
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 17, No. 8 ( 2022-10), p. 931-937
    Abstract: Very early stage blood pressure (BP) levels may affect outcome in stroke patients who have successfully undergone recanalization following intra-arterial treatment, but the optimal target of BP management remains uncertain. Aim We hypothesized that the clinical outcome after intensive BP-lowering is superior to conventional BP control after successful recanalization by intra-arterial treatment. Sample-size estimates We aim to randomize 668 patients (334 per arm), 1:1. Methods and design We initiated a multicenter, prospective, randomized, open-label trial with a blinded end-point assessment (PROBE) design. After successful recanalization (thrombolysis in cerebral infarction score ≥ 2 b), patients with elevated systolic BP level, defined as the mean of two readings ≥ 140 mmHg, will be randomly assigned to the intensive BP-lowering (systolic BP  〈  140 mm Hg) group or the conventional BP-lowering (systolic BP, 140−180 mm Hg) group. Study outcomes The primary efficacy outcomes are from dichotomized analysis of modified Rankin Scale (mRS) scores at three months (mRS scores: 0–2 vs. 3–6). The primary safety outcomes are symptomatic intracerebral hemorrhage and death within three months. Discussion The OPTIMAL-BP trial will provide evidence for the effectiveness of active BP control to achieve systolic BP  〈  140 mmHg during 24 h in patients with successful recanalization after intra-arterial treatment. Clinical trial registration ClinicalTrials.gov Identifier: NCT04205305.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/17474930211041213
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
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  • 8
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    A multiresolution simulation system and simulation development processes
    SAGE Publications ; 2022
    In:  The Journal of Defense Modeling and Simulation: Applications, Methodology, Technology Vol. 19, No. 3 ( 2022-07), p. 325-338
    Details
    In: The Journal of Defense Modeling and Simulation: Applications, Methodology, Technology, SAGE Publications, Vol. 19, No. 3 ( 2022-07), p. 325-338
    Abstract: Defense modeling and simulation often should run multiple simulation models together to share information on their combat entity states and battlefields and to interact with each other. However, most simulation models were developed by various parties with different purposes, modeling views, and model resolutions. Therefore, it has been challenging to identify differences between the models, transform one’s information for the other models, and manage interoperation between the models. There have been numerous works on multiresolution modeling (MRM) and simulation. However, we yet should have more systematic and integrated methods for designing, managing, and executing the interoperation processes of different simulation models. In this paper, we propose an integrated multiresolution simulation system for designing, developing, simulating, and managing multiple simulation models with different modeling views and resolutions. We propose an architecture, component functions, and processes, including model resolution conversion and management processes, and their Unified Modeling Language models. We also extend the Distributed Simulation Engineering and Execution Processes standard to incorporate MRM design and development processes. Finally, we present a case of MRM design and development of war game models by using the proposed system.
    Type of Medium: Online Resource
    ISSN: 1548-5129 , 1557-380X
    URL: Article
    DOI: 10.1177/1548512920966107
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
    detail.hit.zdb_id: 2501647-7
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  • 9
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    Prevalence of Ocular Symptoms in Patients with Allergic Rhinitis: Korean Multicenter Study
    SAGE Publications ; 2013
    In:  American Journal of Rhinology & Allergy Vol. 27, No. 5 ( 2013-09), p. e135-e139
    Details
    In: American Journal of Rhinology & Allergy, SAGE Publications, Vol. 27, No. 5 ( 2013-09), p. e135-e139
    Abstract: Allergic rhinitis (AR) is often accompanied by multiple ocular symptoms. This study aimed to evaluate the prevalence of ocular symptoms and the impact of ocular symptoms on the quality of life in patients with AR. Methods One thousand one hundred seventy-four patients with AR were enrolled from 24 centers in Korea. They were classified into four groups according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) guideline and also classified into perennial AR (PAR) and seasonal AR groups. All patients were asked to complete the questionnaire regarding the presence of ocular symptoms, such as eye itching, watery eyes, and red eyes. The correlation between ocular symptoms and the rest of the quality-of-life areas in the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) was also asked. Results Seven hundred nineteen (61.2%) of 1174 patients had ocular symptoms. In detail, the numbers of patients with eye itching, watery eyes, red eyes, and other ocular symptoms were 605 (51.5%), 313 (26.7%), 207 (17.6%), and 66 (5.6%), respectively. Female patients (72.5%) complained of ocular symptoms more commonly than male patients (55.1%). The patients with moderate–severe persistent AR showed the highest prevalence of ocular symptoms. The correlation coefficients between ocular symptoms and the rest of the quality-of-life areas in the Mini-RQLQ were statistically significant (p 〈 0.05). Conclusion Sixty-one percent of Korean AR patients experienced ocular symptoms. The patients who were women and had PAR and more severe AR showed higher prevalence of ocular symptoms. The ocular symptoms might have a significant impact on the quality of life in patients with AR.
    Type of Medium: Online Resource
    ISSN: 1945-8924 , 1945-8932
    URL: Article
    DOI: 10.2500/ajra.2013.27.3937
    RVK:
    XA 20278
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2013
    detail.hit.zdb_id: 2554548-6
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  • 10
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    Effectiveness and tolerability of methotrexate monotherapy in Crohn’s disease patients: a multicenter observational study
    SAGE Publications ; 2023
    In:  Therapeutic Advances in Gastroenterology Vol. 16 ( 2023-01)
    Details
    In: Therapeutic Advances in Gastroenterology, SAGE Publications, Vol. 16 ( 2023-01)
    Abstract: Methotrexate monotherapy is recommended as a maintenance therapy for Crohn’s disease (CD). However, long-term follow-up data are scarce. Objectives: We aimed to examine the effectiveness and tolerability of methotrexate monotherapy in 94 CD patients from three inflammatory bowel disease Clinics in Korea. Design: This was a multicenter retrospective observational study. Methods: Patients with active CD treated with methotrexate monotherapy were included. Clinical characteristics, laboratory indicators, endoscopy indices were evaluated at baseline, 6, 12, and 24 months. Independent factors associated with long-term clinical and endoscopic outcomes were determined. Results: Methotrexate was administered orally (70.2%) or parenterally (29.8%). The mean methotrexate induction dose was 15.3 ± 0.4 mg/week, and the mean duration of therapy was 26.2 months. Of 76 patients who were treated for 〉 6 months, the clinical remission rates were 76.3%, 74.6%, and 80.0% at 6, 12, and 24 months, respectively, by per-protocol analysis. The mean CRP levels were 7.5 ± 1.3, 5.3 ± 1.2, 3.8 ± 0.7, and 2.6 ± 0.5 mg/L at 0, 6, 12, and 24 months, respectively. Of 31 patients who underwent follow-up endoscopy after 27.5 months, the endoscopic remission rate was 38.7%. Baseline hemoglobin level 〈 10 g/dL was a significant independent factor negatively associated with clinical remission at 6 [odds ratio (OR): 0.023, 95% confidence interval (CI): 0.003–0.206, p = 0.001] and 12 (OR: 0.079, 95% CI: 0.009–0.699, p = 0.023) months. Parenteral administration was a significant independent factor positively associated with clinical remission (OR: 11.231, 95% CI: 1.027–122.811, p = 0.047) and endoscopic remission (hazard ratio: 4.711, 95% CI: 1.398–15.874, p = 0.012) at 12 months. Conclusions: Methotrexate monotherapy was effective and tolerable as a maintenance therapy in CD patients.
    Type of Medium: Online Resource
    ISSN: 1756-2848 , 1756-2848
    URL: Article
    DOI: 10.1177/17562848231191664
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
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