Patterns of mortality after prolonged follow-up of a randomized trial using granulocyte colony-stimulating factor (G-CSF) to maintain chemotherapy dose intensity in non-Hodgkin lymphoma (NHL)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7590-7590
Author(s):  
A. R. Clamp ◽  
S. Bhattacharya ◽  
D. W. Ryder ◽  
R. Pettengell ◽  
J. A. Radford
Keyword(s):  
Randomized Trial ◽  
Dose Intensity ◽  
Rank Test ◽  
Second Malignancies ◽  
Term Survival ◽  
Log Rank Test ◽  
Chemotherapy Dose ◽  
Chemotherapy Dose Intensity

7590 Background: Recombinant G-CSF is commonly used to maintain chemotherapy dose intensity and reduce the incidence of infective complications in the management of NHL. The possible impact of this effect on mortality patterns after prolonged follow-up is worthy of investigation. We investigated the long-term survival and incidence of second malignancies in the first randomized trial utilising recombinant G-CSF in NHL (Pettengell R et al Blood 1992, 80: 1430–1436). Methods: Data on overall survival (OS), progression-free survival (PFS), freedom from progression (FFP) and the incidence of second malignancies were extracted from medical records and cancer registry databases for 80 patients with aggressive subtypes of NHL, who had previously been randomised to receive either VAPEC-B chemotherapy alone (39 patients) or VAPEC-B with G-CSF (41 patients). 10 year survival figures were extracted and Kaplan-Meier survival curves were drawn for the above parameters and compared between treatment groups using the log-rank test. Results: Median follow-up was 11.8 years for surviving patients (range 7.8–13.1 yrs). Patients receiving G-CSF achieved a 12% higher median dose intensity of chemotherapy. No significant differences were found in PFS or OS but 10 year FFP appeared to be better in the G-CSF arm (60.8%) compared with the control arm (45.6%) (log-rank test p=0.12). Eleven deaths from non-NHL causes occurred in the G-CSF arm compared with three in the control arm (log- rank test p=0.06). Five second malignancies were detected on long-term follow-up in the G-CSF arm compared with two in the control arm. Conclusions: The demonstration of different mortality patterns in the two arms may be related to the greater dose intensity of chemotherapy received in the G-CSF arm. Although, our study has insufficient statistical power to draw definite conclusions, this finding warrants further investigation. No significant financial relationships to disclose.

The St. Jude Toronto stentless bioprosthesis: Up to 20 years follow-up in younger patients

2015 ◽  
Vol 18 (4) ◽  
pp. 129 ◽  
Author(s):  
Torsten Christ ◽  
Benjamin Claus ◽  
Robin Borck ◽  
Wolfgang Konertz ◽  
Herko Grubitzsch
Keyword(s):  
Valve Replacement ◽  
Artery Bypass ◽  
Rank Test ◽  
Term Survival ◽  
Younger Patients ◽  
Long Term Survival ◽  
Stentless Bioprosthesis ◽  
Log Rank Test

<p><strong>Background:</strong>A retrospective long-term evaluation of the St. Jude Toronto stentless bioprosthesis in patients aged 60 years or younger.</p><p><strong>Methods:</strong>From 1994 to 1997, 50 patients underwent aortic valve replacement with the prosthesis. Patients mean age at surgery was 54.5±6.3 years. Follow-up data were acquired by patient file research and telephone interviews. Morbidity and mortality were evaluated with time-to-event analyses using the Kaplan-Meier-method. The log-rank test was used to determine influencing factors for long-term survival and reoperation.</p><p><strong>Results:</strong>Mean follow-up was 13.5±6.3 years with a total follow-up of 661.8 patient-years and a maximum of 20.0 years. Follow-up was 97.8% complete. Associated procedures were performed in 12 patients (24%), including coronary artery bypass grafting, mitral valve replacement and replacement of the ascending aorta. Freedom from reoperation at 10 and 15 years was 76.0±6.7% and 44.1±8.9%, respectively. Reoperations (n=26) started 4.4 years after implantation and were necessary due to: valve degeneration with regurgitation in 79.2% and stenosis in 12.5%, endocarditis in 4.2% and sinus valsalva aneurysm in 4.2% of the cases. The log-rank test revealed that only body-mass-index&gt;25 lowered freedom-from-reoperation, while renal dysfunction, diabetes mellitus and arterial hypertension were not. Overall long-term survival at 10 and 20 years was 82.3±5.7% and 49.9±8.9%, respectively.</p><p><strong>Conclusion:</strong>In younger patients the Toronto-bioprosthesis provided reliable long-term survival despite limited durability.</p>

Immediate Postoperative Coagulopathy Predicts the Long-term Survival of Traumatic Brain Injury Patients: a Retrospective Cohort Study

2021 ◽  
Author(s):  
Wenxing Cui ◽  
Tian Li ◽  
Yingwu Shi ◽  
Chen Yang ◽  
Shunnan Ge ◽  
...  
Keyword(s):  
Risk Factors ◽  
Rank Test ◽  
Proportional Hazard ◽  
Proportional Hazard Model ◽  
Term Survival ◽  
Long Term Survival ◽  
Cox Proportional Hazard ◽  
Log Rank Test

Abstract Objective: To assess the association between immediate postoperative coagulopathy and the long-term survival of traumatic brain injury (TBI) patients undergoing surgery, as well as to explore predisposing risk factors of immediate postoperative coagulopathy.Methods: This retrospective study included 352 TBI patients from January 1, 2015, to April 25, 2019. The log-rank test and a Cox proportional hazard model were conducted to assess the relationship between immediate postoperative coagulopathy and the long-term survival of TBI patients. Furthermore, a multivariate logistic regression model was performed to identify the underlying risk factors for postoperative coagulopathy.Results: Of the 352 patients analyzed, the median age was 50 (41,60) years, and 82 (23%) patients were female. By May 26, 2019, 117 (33.24%) patients had died, 195 (55.40%) had survived, and 40 (11.36%) had been lost to follow-up. The median follow-up time was 773 days. In the log-rank test, immediate postoperative coagulopathy was significantly associated with the survival of TBI patients (P = 0.002). A Cox proportional hazard model identified immediate postoperative coagulopathy (HR, 1.471; 95% CI, 1.011-2.141; P = 0.044) as an independent risk factor for survival following TBI. According to multivariate logistic regression analysis, abnormal ALT and RBC at admission, intraoperative infusion of crystalloid solution > 2900 mL, infusion of colloidal solution > 1100 mL and intraoperative bleeding > 950 mL were identified as independent risk factors for immediate postoperative coagulopathy.Conclusions: Those who suffered from immediate postoperative coagulopathy due to TBI were at higher risk of poor prognosis than those who did not.

scholarly journals The relationship of the prolonged PR interval with the long-term survival in patients with heart failure undergoing cardiac resynchronization therapy

2020 ◽  
Vol 25 (1) ◽  
pp. 33-38
Author(s):  
A. M. Soldatova ◽  
V. A. Kuznetsov ◽  
T. P. Gizatulina ◽  
L. M. Malishevsky ◽  
S. M. Dyachkov
Keyword(s):  
Cardiac Resynchronization ◽  
Rank Test ◽  
Term Survival ◽  
Log Rank Test ◽  
Group I ◽  
Pr Interval ◽  
Qrs Duration ◽  
Group Ii ◽  
The Relationship

Aim. To assess the relationship between the prolonged PR interval (≥200 ms) and the long-term survival of patients undergoing cardiac resynchronization therapy (CRT).Material and methods. A total of 85 patients (mean age — 55,1Ѓ}9,9 years; men — 81,2%) with NYHA class II-IV heart failure (HF) were examined. The mean follow-up was 34,0Ѓ}21,2 months. Patients with PR<200 ms (n=52) made up group I, with PR≥200 ms (n=33) — group II. Then the patients were divided into subgroups depending on the QRS duration: ≥150 ms (n=33 in group I and n=14 in group II, respectively) <150 ms (n=19 in group I and n=19 in group II, respectively).Results. In patients of group II, a history of myocardial infarction (MI) was more often registered (p=0,005), left ventricular ejection fraction (LVEF) was lower (p=0,032). In a multivariate analysis, MI (OR 3,217; CI 95% 1,188-8,712; p=0,022) and LVEF value (OR 0,869; CI 95% 0,780-0,968; p=0,011) had a significant relationship with the PR interval prolongation (≥200 ms). The survival of patients of group I was 59,6%, group II — 18,2% (Log-rank test p<0,001). According to Cox regression model, the initial left ventricle end-systolic volume (OR 1,012; 95% CI 1,006-1,017; p<0,001), inferior wall MI (OR 1,690; 95% CI 1,131-2,527; p=0,011) and PR interval ≥200 ms (OR 2,179; 95% CI 1,213–3,915; p=0,009) were associated with long-term mortality. In patients with PR≥200 ms, survival rate was low, regardless of the QRS duration (21,4% in patients with QRS≥150 ms, 15,8% in patients with QRS<150 ms; Log-rank test p=0,698) In patients with PR<200 ms, the survival rate of patients with QRS≥150 ms was 72,7%, and for patients with QRS<150 ms — 36,8% (Log-rank test p=0,031).Conclusion. In HF patients, PR interval prolongation (≥200 ms) is associated with long-term mortality increase. The highest survival rates were observed in patients with PR<200 ms and QRS≥150 ms. In patients with QRS≥150 ms, the presence of PR≥200 ms should be considered as an additional criterion for CRT.

scholarly journals Assessing Long-Term Survival Benefits of Immune Checkpoint Inhibitors Using the Net Survival Benefit

2019 ◽  
Vol 111 (11) ◽  
pp. 1186-1191 ◽  
Author(s):  
Julien Péron ◽  
Alexandre Lambert ◽  
Stephane Munier ◽  
Brice Ozenne ◽  
Joris Giai ◽  
...  
Keyword(s):  
Treatment Effect ◽  
Survival Benefit ◽  
Rank Test ◽  
Cure Rate ◽  
Term Survival ◽  
Long Term Survival ◽  
Delayed Treatment ◽  
Net Survival ◽  
Log Rank Test

Abstract Background The treatment effect in survival analysis is commonly quantified as the hazard ratio, and tested statistically using the standard log-rank test. Modern anticancer immunotherapies are successful in a proportion of patients who remain alive even after a long-term follow-up. This new phenomenon induces a nonproportionality of the underlying hazards of death. Methods The properties of the net survival benefit were illustrated using the dataset from a trial evaluating ipilimumab in metastatic melanoma. The net survival benefit was then investigated through simulated datasets under typical scenarios of proportional hazards, delayed treatment effect, and cure rate. The net survival benefit test was computed according to the value of the minimal survival difference considered clinically relevant. As comparators, the standard and the weighted log-rank tests were also performed. Results In the illustrative dataset, the net survival benefit favored ipilimumab [Δ(0) = 15.8%, 95% confidence interval = 4.6% to 27.3%, P = .006]. This favorable effect was maintained when the analysis was focused on long-term survival differences (eg, >12 months, Δ(12) = 12.5% (95% confidence interval = 4.4% to 20.6%, P = .002). Under the scenarios of a delayed treatment effect and cure rate, the power of the net survival benefit test compared favorably to the standard log-rank test power and was comparable to the power of the weighted log-rank test for large values of the threshold of clinical relevance. Conclusion The net long-term survival benefit is a measure of treatment effect that is meaningful whether or not hazards are proportional. The associated statistical test is more powerful than the standard log-rank test when a delayed treatment effect is anticipated.

Long-Term Survival Analysis of the North American Intergroup Study C9011 Comparing Fludarabine (F) and Chlorambucil (C) in Previously Untreated Patients with Chronic Lymphocytic Leukemia (CLL).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 536-536 ◽  
Author(s):  
Kanti R. Rai ◽  
Bercedis L. Peterson ◽  
Frederick R. Appelbaum ◽  
Martin S. Tallman ◽  
Andrew Belch ◽  
...  
Keyword(s):  
Hodgkin Lymphoma ◽  
Initial Treatment ◽  
Conflicts Of Interest ◽  
High Morbidity ◽  
Second Malignancies ◽  
Long Term Outcomes ◽  
Term Survival ◽  
Prolymphocytic Leukemia

Abstract Abstract 536 Long-term outcomes following novel therapies for CLL have rarely been reported. Between 10/90 and 12/94, 509 eligible, untreated patients (pts) with symptomatic CLL were enrolled by 4 cooperative groups onto study C9011; 179 were randomized to F, 193 to C, and 137 to F+C. After slightly more than 5 years median follow up, with the time of last follow-up in June 1999, we reported in 2000 (NEJM 343:1750) that F provided significantly higher response rates and longer remission duration and progression-free survival (PFS) than C (p<0.001 for all 3 endpoints). The combination arm with F+C was stopped early because of high morbidity and mortality. There was no difference in overall survival (OS) among the 3 groups. Nearly 10 years have now elapsed since this report. Therefore, with the time of last follow-up in January 2009, we analyzed the long term outcomes of pts enrolled on the study. PFS was defined as the time between randomization and the occurrence of progressive disease or death due to any cause. Results: Of the 509 pts, 85% have now died; among pts on the F and C arms, 92% have progressed. We found that F treatment resulted in significantly longer PFS than did C (p < 0.001), with notable differences in PFS at 2, 3, and 4 years (Table). While the F and C arms had the same OS during the initial 5 years following randomization, our current analysis with longer follow-up shows that pts treated on the F arm had better survival than did those on the C arm during the ensuing years (Figure). The p-values for this difference are 0.04 (unadjusted for covariates) and 0.07 (covariate-adjusted). The emergence of improved survival following initial F treatment, appearing only after 5-6 years, is an unexpected and noteworthy finding. Reporting second malignancies was required on this study. There were 27 epithelial cancers reported (9 on F, 11 on C, 7 on F+C), involving colon, lung, breast, prostate, pancreas, liver, bladder and skin (6 squamous, 2 melanoma). Seven therapy-related myeloid neoplasms (t-MN) were reported; 6 were on F+C; 1 on F. Richter's transformation to non-Hodgkin lymphoma was reported in 34 pts; prolymphocytic leukemia occurred in 10; Hodgkin lymphoma in 6; myeloma in 2; hairy cell leukemia in 1. These cases were distributed with 18 on F, 18 on C, and 17 on F+C. Thus, the overall incidence of second malignancies reported was 17%. Conclusion: Initial treatment with F provides better long-term outcomes than initial treatment with C. Second malignancies are common, but the overall incidence is not increased on the F-containing treatment arms except for t-MN. Disclosures: No relevant conflicts of interest to declare.

A single-center retrospective study of patients treated with trabectedin (TRB) with long-term follow up.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 11061-11061
Author(s):  
Brett A. Schroeder ◽  
Chad He ◽  
Yuzheng Zhang ◽  
Michael Wagner ◽  
Robin Lewis Jones ◽  
...  
Keyword(s):  
Demographic Variables ◽  
Rank Test ◽  
Prior Chemotherapy ◽  
Pairwise Correlation ◽  
Log Rank Test ◽  
Long Term Follow Up ◽  
Line Of Therapy ◽  
Clinical Trial Information

11061 Background: TRB is FDA approved drug for the treatment of liposarcoma (Lipo) and leiomyosarcoma (LMS). The aim of this study was to evaluate potential biomarkers associated with prolonged benefit in patients treated with TRB at our center prior to 2016. Methods: We performed a retrospective search of UW/FHCRC CASIS database to identify patients treated with TRB prior to 2016. Demographic variables and clinical variables (such as histology and treatment) were retrieved. Statistics were performed with R 3.4.1 software. Pairwise Pearson’s correlation was calculated for the # of prior chemotherapy regimens with # of TRB cycles. The Kaplan-Meir method was used to evaluate overall survival (OS). Log-rank test was conducted to compare groups in terms of OS. Results: 145 sarcoma patients treated with TRB were identified with a mean follow up of 5 years (generally on NCT01427582 or NCT01343277). Patients averaged 1.9 prior chemotherapy regimens prior to TRB (range 0-7 regimens) and received an average of 5.6 TRB doses (range 1-25 doses). Subtypes are listed on table. The # of prior regimens was negatively correlated with the # of TRB cycles that patients received (pairwise correlation coefficient = -1.77; p=0.034), suggesting that multiple prior treatment lines either made TRB less tolerable or made sarcoma less sensitive to TRB. The median OS for this heavily treated metastatic population was 0.5 years. However, patients who were able to stay on TRB for more than 5 cycles had a significantly higher OS (p=0.001). While only 23% of patients who received less than 5 cycles of TRB were alive at 5 years (95% CI: 0.15, 0.32), 53% of those who received 5 or more cycles of (95% CI: 0.39, 0.65) were alive at 5 years. Conclusions: TRB may be more effective when administered as an earlier line of therapy. Patients who are able to stay on TRB for a longer duration had a significant improvement in OS. Detailed subset analysis will be presented as will initial findings of our biomarker work. These retrospective data warrant further evaluation. Clinical trial information: NCT01427582 or NCT01343277. [Table: see text]

scholarly journals 10-year clinical outcomes after radiofrequency catheter ablation for atrial fibrillation. A single center experience

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
J.F Alderete Martinez ◽  
S Shizuta ◽  
F Yoneda ◽  
S Nishiwaki ◽  
M Tanaka ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Adverse Events ◽  
Confidence Interval ◽  
Clinical Outcomes ◽  
Radiofrequency Catheter Ablation ◽  
Rank Test ◽  
Log Rank Test

Abstract Background Radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF) is becoming a routine procedure to treat patients with drug-refractory symptomatic AF. However, data regarding very long-term clinical outcomes is limited. The aim of the present study was to evaluate the 10-year clinical outcomes of patients who underwent RFCA for paroxysmal and persistent AF. Methods We retrospectively enrolled 503 consecutive patients (mean age 66,9±9,51 years; 71,6% male) who underwent RFCA for drug-refractory symptomatic AF between February 2004 and June 2011. Follow-up information was obtained using medical records and/or telephonic interviews with the patient, relatives and/or referring physicians. Results Among 503 patients enrolled in this study, 362 had paroxysmal atrial fibrillation (PAF) and 141 had persistent atrial fibrillation (PeAF) (72% and 28%, respectively). Mean follow-up was 8,84±3,05 years. The 10-year event-free rate for recurrent atrial tachyarrhythmia (AT) after the first procedure was 44,5% (49,4% for PAF vs 31,9% for PeAF; p=0,002 by log-rank test) and 81,9% after the last procedure (87,3% for PAF and 67,9% for PeAF; p≤0,001 by log-rank test). AT recurrence was observed most commonly during the first 12 months of the initial procedure (56%), with only 18% of them occurring after 60 months. Multivariate analysis revealed that persistent AF (hazard ratio=1,366; 95% confidence interval 1,058–1,76; p=0,017) and duration of AF &gt;5 years (hazard ratio=1,357; 95% confidence interval 1,064–1,732; p=0,005) were independent risk factors for AT recurrence. Regarding adverse events, there were 24 (4,8%) hospitalizations for acute decompensated heart failure, 20 (4%) ischemic strokes and 14 (2,8%) bleeding complications requiring hospital admissions. Patients taking oral anticoagulation and antiarrhythmic drugs at the end of the study accounted for 32,8% and 16,7% respectively. Conclusions RFCA for AF provided favorable results in terms of arrhythmia event-free survival in long-term follow-up with better results in patients with paroxysmal AF. Persistent AF and long-standing AF (beyond 5 years) were associated with AT recurrence. Despite the large number of patients who discontinued oral anticoagulation, thromboembolic adverse events were rare. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals Impact of monitoring on detection of arrhythmia recurrences in the ESC-EHRA EORP atrial fibrillation ablation long-term registry

EP Europace ◽  
2019 ◽  
Vol 21 (12) ◽  
pp. 1802-1808
Author(s):  
Tosho Balabanski ◽  
Josep Brugada ◽  
Elena Arbelo ◽  
Cécile Laroche ◽  
Aldo Maggioni ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Atrial Fibrillation Ablation ◽  
Rank Test ◽  
Lower Probability ◽  
Monitoring Methods ◽  
Holter Ecg ◽  
Af Ablation ◽  
Log Rank Test

Abstract Aims Monitoring of patients after ablation had wide variations in the ESC-EHRA atrial fibrillation ablation long-term (AFA-LT) registry. We aimed to compare four different monitoring strategies after catheter AF ablation. Methods and results The ESC-EHRA AFA-LT registry included 3593 patients who underwent ablation. Arrhythmia monitoring during follow-up was performed by 12-lead electrocardiogram (ECG), Holter ECG, trans-telephonic ECG monitoring (TTMON), or an implanted cardiac monitoring (ICM) system. Patients were selected to a given monitoring group according to the most extensive ECG tool used in each of them. Comparison of the probability of freedom from recurrences was performed by censored log-rank test and presented by Kaplan–Meier curves. The rhythm monitoring methods were used among 2658 patients: ECG (N = 578), Holter ECG (N = 1874), TTMON (N = 101), and ICM (N = 105). A total of 767 of 2658 patients (28.9%) had AF recurrences during follow-up. Censored log-rank test discovered a lower probability of freedom from relapses, which was detected with ICM compared to TTMON, ECG, and Holter ECG (P < 0.001). The rate of freedom from AF recurrences was 50.5% among patients using the ICM while it was 65.4%, 70.6%, and 72.8% using the TTMON, ECG, and Holter ECG, respectively. Conclusion Comparing all main electrocardiographic monitoring methods in a large patient sample, our results suggest that post-ablation recurrences of AF are significantly underreported by TTMON, ECG, and Holter ECG. The ICM estimates AF ablation recurrences most reliably and should be a preferred mode of monitoring for trials evaluating novel AF ablation techniques.

Randomized trial of amifostine in locally advanced non-small cell lung cancer (NSCLC) patients receiving chemotherapy and hyperfractionated radiation (HRT): Long-term survival results of Radiation Therapy Oncology Group (RTOG) 9801

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7529-7529
Author(s):  
B. Movsas ◽  
J. Moughan ◽  
C. Langer ◽  
M. Werner-Wasik ◽  
N. Nicolaou ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Radiation Therapy Oncology Group ◽  
Disease Free Survival ◽  
Rank Test ◽  
Term Survival ◽  
Long Term Survival ◽  
Patient Reported ◽  
Nsclc Patients

7529 Purpose: This analysis was conducted to address the potential antitumor effect of amifostine (AM) in NSCLC patients enrolled on RTOG-9801. The long-term survival results of RTOG-9801 are presented here. Methods: 243 patients (pts) with stage II/IIIAB NSCLC received induction paclitaxel (P) 225 mg/m2IV days 1, 22 and carboplatin (C) AUC 6 days 1, 22 and then concurrent weekly P (50 mg/m2) and C (AUC 2) and HRT (69.6 Gy at 1.2 Gy BID). Pts were randomly assigned to AM 500 mg IV 4x/week or no-AM during chemoradiation. Treatment differences for overall and disease-free survival (OS & DFS) were analyzed with the log-rank test; Gray's test was used for time to progression (TTP). Results: 118 pts were randomly assigned to receive AM and 121 to no-AM (4 pts were ineligible). The median follow-up for pts still alive is 52.3 months (mo) for the AM-arm and 58.3 mo for the no-AM arm (16.6 vs 17.9 for all pts). There are no significant differences in OS, DFS or TTP between arms. The median survival, 3-yr, and 5-yr OS are 17.1 mo, 27% and 17% (AM-arm) vs 18.4 mo, 28% and 16% (no-AM arm) (p=0.97). Grade 3/4/5 late-RT toxicities are similar (11%/3%/2% AM-arm vs 14%/4%/2% no-AM arm). Conclusion: While an earlier publication reported that amifostine did not reduce objective measures of severe esophagitis in RTOG-9801, patient-reported outcome analyses suggested a possible advantage to AM with decreased pain and swallowing symptoms (J Clin Oncol 23:2145–2154, 2005). This long-term follow-up analysis on survival shows no evidence of tumor radioprotection due to amifostine. The promising 5-yr OS suggests that induction paclitaxel/carboplatin (P/C) followed by concurrent RT and weekly low-dose P/C is comparable to other regimens using cisplatin doublets at higher dosages every 3–4 weeks. Research supported by NCI and Medimmune Oncology. No significant financial relationships to disclose.

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