scholarly journals Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labelled trial

2020 ◽  
Author(s):  
Arsene Mekinian ◽  
David Saadoun ◽  
Eric Vicaut ◽  
Sarah Thietart ◽  
Bertrand Lioger ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Disease Activity ◽  
Primary Endpoint ◽  
Takayasu Arteritis ◽  
Number Of Patients ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
Steroid Sparing

Abstract ObjectivesTo assess long term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).MethodsProspective open-labelled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients which discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during an 18-month follow-up.ResultsThirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3-4] at baseline, versus 1 [0-2] after 6 months; p <0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. During the 12 months follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab.ConclusionTocilizumab seems an effective steroid sparing therapy in TAK but maintenance therapy is necessary.

scholarly journals Tocilizumab in treatment-naïve patients with Takayasu arteritis: TOCITAKA French prospective multicenter open-labeled trial

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Arsene Mekinian ◽  
◽  
David Saadoun ◽  
Eric Vicaut ◽  
Sara Thietart ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Disease Activity ◽  
Primary Endpoint ◽  
Takayasu Arteritis ◽  
Number Of Patients ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
Steroid Sparing

Abstract Objectives To assess long-term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK). Methods Prospective open-labeled trial in naïve patients with TAK who received steroids at the dose of 0.7 mg/kg/day and 7 infusions of 8 mg/kg/month of tocilizumab. The primary endpoint was the number of patients who discontinued steroids after 7 infusions of tocilizumab. Secondary endpoints included disease activity and the number of relapses during 18-month follow-up. Results Thirteen patients with TAK were included, with a median age of 32 years [19–45] and 12 (92%) females. Six (54%) patients met the primary end-point. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3, 4] at baseline, versus 1 [0–2] after 6 months; p < 0.001), ITAS-2010 score (5 [2–7] versus 3 [0–8]; p = 0.002), and ITAS-A score (7 [4–10] versus 4 [1–15]; p = 0.0001)]. During the 12-month follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab. Conclusion Tocilizumab seems an effective steroid sparing therapy in TAK, but maintenance therapy is necessary. Trial registration ClinicalTrials.gov NCT02101333. Registered on 02 April 2014.

scholarly journals AB0509 SUSPENSIVE EFFICACY OF TOCILIZUMAB IN TREATMENT-NAÏVE PATIENTS WITH TAKAYASU ARTERITIS: TOCITAKA FRENCH PROSPECTIVE MULTICENTER OPEN-LABELLED TRIAL.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1552.3-1552
Author(s):  
A. Mekinian ◽  
D. Saadoun ◽  
J. C. N. F. [email protected] ◽  
I. Q. M. F. [email protected] ◽  
P. Jégo ◽  
...  
Keyword(s):  
Disease Activity ◽  
Takayasu Arteritis ◽  
Immunosuppressive Drugs ◽  
Relapse Free Survival ◽  
Research Support ◽  
Free Survival ◽  
Treatment Naïve ◽  
Steroid Sparing

Objectives:To assess long term efficacy of tocilizumab in treatment-naive patients with Takayasu arteritis (TAK).Methods:In this multicenter, prospective, open-labelled trial, we aim to evaluate the benefit of adding tocilizumab to steroids in treatment-naïve patients with TAK, on discontinuation of steroids after 6 months of tocilizumab treatment, and to assess relapse-free survival following tocilizumab discontinuation.Results:Thirteen patients with TAK were included, with a median age of 32 years [19-45] and 12 (92%) females. Six (54%) patients met the primary end-point. Among 11 (85%) patients which achieved remission at 6 months, 6 (54%) have reached primary endpoint.. Among the 5 remaining patients which continued steroids, 3 had a prednisone-equivalent dosage < 5mg/day. A significant decrease of disease activity was observed after 6 months of tocilizumab therapy: decrease of median NIH scale (3 [3-4] at baseline, versus 1 [0-2] after 6 months; p <0.001), ITAS-2010 score (5 [2-7] versus 3 [0-8]; p = 0.002), and ITAS-A score (7 [4-10] versus 4 [1-15]; p = 0.0001)]. All patients discontinued tocilizumab after 7 infusions, and no other immunosuppressive drugs was introduced, except for 1 patient which received methotrexate. After 9 and 12 months, respectively 7 (54%) and 6 (50%) patients achieved remission with less than 7.5 mg/day of prednisone, and 9 (69%) and 9 (75%) with doses <10 mg/day. During the 12 months follow-up after tocilizumab discontinuation, a relapse occurred among 5 patients (45%) out of 11 in which achieved remission after 6 months of tocilizumab.No severe AEs were considered related to study treatment and none required tocilizumab interruption or dose reduction. No deaths have occurred during the study period.Conclusion:Tocilizumab seems an effective steroid sparing therapy in TAK but its effect appears to be suspensive.Disclosure of Interests:Arsene Mekinian: None declared, david Saadoun: None declared, [email protected] [email protected]: None declared, [email protected] [email protected]: None declared, Patrick Jégo: None declared, [email protected] [email protected]: None declared, wxv wxv: None declared, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Mathieu Vautier: None declared, [email protected]>; [email protected]>;: None declared, Patrice cacoub: None declared, olivier fain: None declared

scholarly journals Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Anna-Lotta Irewall ◽  
Anders Ulvenstam ◽  
Anna Graipe ◽  
Joachim Ögren ◽  
Thomas Mooe
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Endpoint ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Control Group ◽  
Coronary Syndrome ◽  
Secondary Endpoints ◽  
Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

scholarly journals Long-term benefits of targeted micronutrition with the holoBLG lozenge in house dust mite allergic patients

2022 ◽  
Author(s):  
Karl-Christian Bergmann ◽  
Jennifer Raab ◽  
Linda Krause ◽  
Sylvia Becker ◽  
Sebastian Kugler ◽  
...  
Keyword(s):  
Lung Function ◽  
Primary Endpoint ◽  
House Dust Mite ◽  
Temporal Evolution ◽  
Well Being ◽  
Dust Mite ◽  
Symptom Scores ◽  
Secondary Endpoints

Summary Purpose The long-term effects of targeted micronutrition with the holoBLG lozenge in house dust mite (HDM) allergic rhinoconjunctivitis (ARC) patients were evaluated at a follow-up visit in an allergen exposure chamber (AEC). Methods Patients who were supplemented for 3‑months with the holoBLG lozenge in a previous study with two controlled HDM-AEC challenges [visits: V1, V3] were recruited for a third AEC challenge (V5) 7–8 months after cessation of supplementation. Symptoms (nose, conjunctival, bronchial, others), well-being, and lung function parameters were recorded exactly as in the previous study. Primary endpoint was change in median Total Nasal Symptom Score (TNSS) at V5 compared to V1. Secondary endpoints included e.g. change in median Total Symptom Score (TSS) and the exploratory analysis of temporal evolution of symptom scores using linear mixed effects models. Results Of the 32 patients included in the original study, 27 could be recruited for the follow-up visit with a third AEC challenge. An improvement of 20% (p = 0.15) in the primary endpoint TNSS [V1: 2.5 (interquartile range [IQR]: 1–4), V5: 2.0 (IQR: 1–3)] was observed; 40% (p = 0.04) improvement was seen for the TSS [V1: 5.0 (IQR: 3–9), V5: 3.0 (IQR: 2–5.5)]. Analysis of temporal evolution of all symptom scores, and the personal well-being revealed sustained, clinically meaningful improvement at V5 compared to V1. No relevant lung function parameter differences were observed. Conclusions Sustained long-term reduction of TNSS (primary endpoint) and sustained long-term improvement of secondary endpoints (temporal evolution of all symptom scores and well-being) were demonstrated 7–8 months after cessation of holoBLG supplementation, indicative of a long-lasting nature of immune resilience induced by holoBLG. Trial registration The study was registered at clinicaltrials.gov (NCT04872868).

scholarly journals Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study

10.2196/16959 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e16959
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Clinical Success ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Intraoperative Radiation ◽  
Nonrandomized Study ◽  
Aortic Repair ◽  
Number Of Patients

Background Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. Objective The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. Methods All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. Results The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients’ baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. Conclusions This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval. International Registered Report Identifier (IRRID) PRR1-10.2196/16959

scholarly journals Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223

2020 ◽  
Vol 267 (11) ◽  
pp. 3343-3353 ◽  
Author(s):  
Brian Steingo ◽  
◽  
Yaser Al Malik ◽  
Ann D. Bass ◽  
Regina Berkovich ◽  
...  
Keyword(s):  
Disease Activity ◽  
Efficacy And Safety ◽  
Open Label ◽  
Disease Modifying Therapies ◽  
Disability Status ◽  
Relapsing Remitting ◽  
Scale Scores ◽  
Treatment Naïve

Abstract Background In the phase 2 CAMMS223 trial (NCT00050778), alemtuzumab significantly improved clinical and MRI outcomes versus subcutaneous interferon beta-1a over 3 years in treatment-naive patients with relapsing–remitting MS. Here, we assess efficacy and safety of alemtuzumab over 12 years in CAMMS223 patients who enrolled in the CAMMS03409 extension (NCT00930553), with available follow-up through the subsequent TOPAZ extension (NCT02255656). Methods In CAMMS223, patients received 2 alemtuzumab courses (12 mg/day; baseline: 5 days; 12 months later: 3 days); 22% received a third course. In the open-label, nonrandomized extensions, patients could receive as-needed additional alemtuzumab or other disease-modifying therapies. Results Of 108 alemtuzumab-treated patients in CAMMS223, 60 entered the CAMMS03409 extension; 33% received a total of 2 alemtuzumab courses, and 73% received no more than 3 courses through Year 12. Over 12 years, annualized relapse rate was 0.09, 71% of patients had stable or improved Expanded Disability Status Scale scores, and 69% were free of 6-month confirmed disability worsening. In Year 12, 73% of patients were free of MRI disease activity. Cumulatively throughout the extensions (Years 7–12), 34% of patients had no evidence of disease activity. Adverse event (AE) incidence declined through Year 12. Infusion-associated reactions peaked at first course and declined thereafter. Cumulative thyroid AE incidence was 50%; one immune thrombocytopenia event occurred, and there were no autoimmune nephropathy cases. Conclusions Alemtuzumab efficacy was maintained over 12 years in CAMMS223 patients, with 73% receiving no more than three courses. The safety profile in this cohort was consistent with other alemtuzumab clinical trials.

scholarly journals Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study (Preprint)

2019 ◽  
Author(s):  
Roberto Silingardi ◽  
Pasqualino Sirignano ◽  
Francesco Andreoli ◽  
Wassim Mansour ◽  
Mattia Migliari ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Clinical Success ◽  
Aortic Aneurysms ◽  
Endovascular Aortic Repair ◽  
Intraoperative Radiation ◽  
Nonrandomized Study ◽  
Aortic Repair ◽  
Number Of Patients

BACKGROUND Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. OBJECTIVE The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. METHODS All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. RESULTS The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients’ baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. CONCLUSIONS This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/16959

S0536: Carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab maintenance in advanced non-small cell lung cancer (NSCLC): A SWOG phase II study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 8015-8015 ◽  
Author(s):  
D. Gandara ◽  
E. S. Kim ◽  
R. S. Herbst ◽  
J. Moon ◽  
M. W. Redman ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Advanced Nsclc ◽  
Progression Free Survival ◽  
Predictive Biomarker ◽  
Phase Iii ◽  
Platinum Based Chemotherapy ◽  
Treatment Naïve ◽  
Secondary Endpoints ◽  
Lung Hemorrhage

8015 Background: Cetuximab (CX) plus platinum-based chemotherapy improves overall survival (OS) in advanced NSCLC (FLEX). SWOG previously showed that EGFR FISH is associated with efficacy outcomes in patients (pts) receiving CB/P/CX (S0342). Bevacizumab (B) plus chemotherapy also increases survival (E4599) in eligible pts. Given the biologic rationale for combining EGFR and VEGFR targeted agents, S0536 investigated the safety and efficacy of carboplatin (CB), paclitaxel (P) and CX plus B. Methods: Eligibility: treatment-naïve advanced stage non-squamous cell NSCLC, no requirement for EGFR positivity, PS 0–1, no brain metastases or hemoptysis. Treatment: CB AUC 6, P 200 mg/m2, B 15 mg/kg IV day 1 every 3 weeks, CX 400 mg/m2 day 1 then 250 mg/m2 weekly for up to 6 cycles; then B 15 mg/kg every 3 weeks and CX 250 mg/m2 weekly until progression. Primary endpoint: feasibility defined by the frequency and severity of ≥grade 4 hemorrhagic toxicities. Secondary endpoints: response rate, progression-free survival (PFS), OS and toxicity. Results: 110 pts enrolled from August 2006 to September 2007; 104 assessable. Pt characteristics: median age 64 years (42–78), Male/Female 52/52, PS 0/1 43/61, stage IIIB/IV 9/95, adenocarcinoma: 81, current/former smoker: 82. Overall toxicities were acceptable and comparable to S0342 and E4599. Primary endpoint was met: grade ≥4 hemorrhage: 2% (95% CI: 0–7%). There were 4 treatment-related deaths: lung hemorrhage (2), infection (1), unknown (1). Partial response (PR): 51/95 assessable (54%; 43%-64%); Stable disease (SD): 22/95 (23%). Disease control rate (PR+SD): 77%. With median follow up of 15 months (mos), PFS is 7 mos (18 pts remain progression-free) and OS is 14 mos. 1 year survival is 57% (47–67%). EGFR IHC by H score (>0 vs 0) showed a nonsignificant trend toward improved survival: 15 vs 11 mos (p=0.14). Conclusions: CB/P, CX plus B demonstrates safety, tolerability and efficacy in advanced NSCLC and is the most active regimen studied to date in SWOG. Additional S0536 biomarker studies including EGFR FISH will be presented. S0819, a Phase III trial of CB/P ± CX (plus B in eligible pts) is under development and is designed to validate EGFR FISH as a predictive biomarker. [Table: see text]

Updated outcomes of POUT: A phase III randomized trial of peri-operative chemotherapy versus surveillance in upper tract urothelial cancer (UTUC).

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 455-455
Author(s):  
Alison Jane Birtle ◽  
John David Chester ◽  
Robert J. Jones ◽  
Ben Jenkins ◽  
Mark Johnson ◽  
...  
Keyword(s):  
Overall Survival ◽  
Primary Endpoint ◽  
Data Monitoring Committee ◽  
Phase Iii ◽  
Free Survival ◽  
Risk Of Death ◽  
Patient Reported ◽  
Secondary Endpoints

455 Background: The POUT trial (CRUK/11/027; NCT01993979) previously reported (with median follow-up 30.3 months) that adjuvant chemotherapy improves disease free survival (DFS) for patients (pts) with histologically confirmed pT2-T4 N0-3 M0 UTUC. Here we present results of a pre-planned analysis updating the primary endpoint and reporting key secondary endpoints including overall survival. Methods: 261 pts with UTUC were enrolled following nephro-ureterectomy and randomised (1:1) to 4 cycles of gemcitabine-cisplatin (gemcitabine-carboplatin if GFR 30-49ml/min) or surveillance with subsequent chemotherapy if required. Pts had 6 monthly imaging and cystoscopy for 2 years, then annually to 5 years. Toxicity was assessed by CTCAE v4. Primary endpoint was DFS. Secondary endpoints included metastasis free survival (MFS), overall survival (OS), toxicity and patient reported quality of life (QoL). The trial closed to recruitment early on advice of the independent data monitoring committee due to evidence of efficacy. Time-to-event endpoints are analysed (intention-to-treat) by Cox proportional hazard models. Unadjusted and adjusted (by nodal status, planned chemotherapy type, microscopic margin status, pathological stage) hazard ratios (HR, < 1 favouring chemotherapy) are reported. Results: From May 2012 to Nov 2017, 261 pts were recruited (129 surveillance; 132 chemotherapy) at 56 UK centres. One participant withdrew consent for data usage and was excluded from analyses. Pts had median age 69 years (range 37-88), 28% pT2, 66% pT3; 91% pN0. To 09/09/2020, median follow up was 48.1 months (IQR: 36.0-60.1). The unadjusted/adjusted HR for DFS was 0.48 (95% CI: 0.33-0.71; p = 0.0003) / 0.50 (95%CI: 0.34-0.75; p = 0.001), and for MFS was 0.52 (95% CI: 0.35-0.77; p = 0.001) / 0.54 (95% CI: 0.36-0.81; p = 0.002). 93/260 (35.8%) pts have died (52/129 [40.3%] surveillance and 41/131 [31.3%] chemotherapy). Chemotherapy conferred a non-statistically significant 28% reduction in relative risk of death (HR = 0.72, 95% CI: 0.47-1.08; p = 0.11; adjusted HR = 0.79, 95% CI: 0.52-1.19; p = 0.26). 3 year OS was surveillance: 67% (95% CI: 58-74%; chemotherapy: 79% (71%-85%). There was no evidence of long-term toxicity associated with chemotherapy (Wilcoxon rank-sum test p-value for worst grade post-6 months = 0.32). Most common grade 2+ adverse events were hypertension (25/240 [10.4%]), lethargy (25/240 [10.4%]) and hearing loss (13/240 [5.4%]). There was no evidence of statistically or clinically relevant differences in QoL. 12 months after treatment (EORTC Q30 global health status mean difference 4.1 and 4.8 at 12 and 24 months respectively in favour of chemotherapy). Conclusions: With additional follow-up, the previously reported DFS benefit for chemotherapy was maintained with no detrimental long-term toxicity. No statistically significant improvement in OS was observed. Clinical trial information: NCT01993979.

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