scholarly journals Innovative Synoptic Reporting With Seven-Point Sampling Protocol to Improve Detection Rate of Microvascular Invasion in Hepatocellular Carcinoma

2021 ◽  
Vol 11 ◽  
Author(s):  
Bing Liao ◽  
Lijuan Liu ◽  
Lihong Wei ◽  
Yuefeng Wang ◽  
Lili Chen ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Detection Rate ◽  
Clinical Information ◽  
Microvascular Invasion ◽  
Pathological Examination ◽  
Rank Test ◽  
Point Sampling ◽  
Significant Difference ◽  
The Impact ◽  
Synoptic Reporting

Pathological MVI diagnosis could help to determine the prognosis and need for adjuvant therapy in hepatocellular carcinoma (HCC). However, narrative reporting (NR) would miss relevant clinical information and non-standardized sampling would underestimate MVI detection. Our objective was to explore the impact of innovative synoptic reporting (SR) and seven-point sampling (SPRING) protocol on microvascular invasion (MVI) rate and patient outcomes. In retrospective cohort, we extracted MVI status from NR in three centers and re-reviewed specimen sections by SR recommended by the College of American Pathologists (CAP) in our center. In prospective cohort, our center implemented the SPRING protocol, and external centers remained traditional pathological examination. MVI rate was compared between our center and external centers in both cohorts. Recurrence-free survival (RFS) before and after implementation was calculated by Kaplan-Meier method and compared by the log-rank test. In retrospective study, we found there was no significant difference in MVI rate between our center and external centers [10.3% (115/1112) vs. 12.4% (35/282), P=0.316]. In our center, SR recommended by CAP improved the MVI detection rate from 10.3 to 38.6% (P<0.001). In prospective study, the MVI rate in our center under SPRING was significantly higher than external centers (53.2 vs. 17%, P<0.001). RFS of MVI (−) patients improved after SPRING in our center (P=0.010), but it remained unchanged in MVI (+) patients (P=0.200). We conclude that the SR recommended by CAP could help to improve MVI detection rate. Our SPRING protocol could help to further improve the MVI rate and optimize prognostic stratification for HCC patients.

scholarly journals Revisiting Surgical Strategies for Hepatocellular Carcinoma With Microvascular Invasion

2021 ◽  
Vol 11 ◽  
Author(s):  
Er-lei Zhang ◽  
Qi Cheng ◽  
Zhi-yong Huang ◽  
Wei Dong
Keyword(s):  
Hepatocellular Carcinoma ◽  
Surgical Outcomes ◽  
Surgical Margin ◽  
Preoperative Assessment ◽  
Microvascular Invasion ◽  
Pathological Examination ◽  
R0 Resection ◽  
International Consensus ◽  
Surgical Strategies ◽  
The Impact

Although liver resection (LR) and liver transplantation (LT) are widely considered as potentially curative therapies for selected patients with hepatocellular carcinoma (HCC); however, there is still high risk of tumor recurrence in majority of HCC patients. Previous studies demonstrated that the presence of microvascular invasion (MVI), which was defined as the presence of tumor emboli within the vessels adjacent to HCC, was one of the key factors of early HCC recurrence and poor surgical outcomes after LR or LT. In this review, we evaluated the impact of current MVI status on surgical outcomes after curative therapies and aimed to explore the surgical strategies for HCC based on different MVI status with evidence from pathological examination. Surgical outcomes of HCC patients with MVI have been described as a varied range after curative therapies due to a broad spectrum of current definitions for MVI. Therefore, an international consensus on the validated definition of MVI in HCC is urgently needed to provide a more consistent evaluation and reliable prediction of surgical outcomes for HCC patients after curative treatments. We concluded that MVI should be further sub-classified into MI (microvessel invasion) and MPVI (microscopic portal vein invasion); for HCC patients with MPVI, local R0 resection with a narrow or wide surgical margin will get the same surgical results. However, for HCC patients with MI, local surgical resection with a wide and negative surgical margin will get better surgical outcomes. Nowadays, MVI status can only be reliably confirmed by histopathologic evaluation of surgical specimens, limiting its clinical application. Taken together, preoperative assessment of MVI is of utmost significance for selecting a reasonable surgical modality and greatly improving the surgical outcomes of HCC patients, especially in those with liver cirrhosis.

scholarly journals Effect of Microvascular Invasion on the Prognosis in Hepatocellular Carcinoma and Analysis of Related Risk Factors: A Two-Center Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Wang Yanhan ◽  
Lu Lianfang ◽  
Liu Hao ◽  
Ding Yunfeng ◽  
Song Nannan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Hepatocellular Carcinoma ◽  
Logistic Regression ◽  
Regression Analysis ◽  
Logistic Regression Analysis ◽  
Multivariate Logistic Regression Analysis ◽  
Microvascular Invasion ◽  
Pathological Examination ◽  
Related Risk ◽  
The Impact

Objective: Microvascular invasion is considered to initiate intrahepatic metastasis and postoperative recurrence of hepatocellular carcinoma (HCC). We aimed to analyze the effect of MVI on the prognosis in HCC and identify related risk factors for microvascular invasion (MVI).Methods: The clinical data of 553 HCC patients who underwent liver surgery at Qingdao University from January 2014 to December 2018 and 89 patients at Beijing Tsinghua Changgung Hospital treated between October 2014 and October 2019 were collected retrospectively. We explored the impact of MVI on the prognosis of patients with HCC using Kaplan-Meier analysis. We conducted logistic regression analysis to identify variables significantly related to MVI.Results: Pathological examination confirmed the presence of MVI in 265 patients (41.3%). Six factors independently correlated with MVI were incorporated into the multivariate logistic regression analysis: Edmondson-Steiner grade [odds ratio (OR) = 3.244, 95%CI: 2.243–4.692; p < 0.001], liver capsule invasion (OR = 1.755; 95%CI: 1.215–2.535; p = 0.003), bile duct tumor thrombi (OR = 20.926; 95%CI: 2.552–171.553; p = 0.005), α-fetoprotein (> 400 vs. < 400 ng/ml; OR = 1.530; 95%CI: 1.017–2.303; p = 0.041), tumor size (OR = 1.095; 95%CI: 1.027–1.166; p = 0.005), and neutrophil-lymphocyte ratio (OR = 1.086; 95%CI: 1.016–1.162; p = 0.015). The area under the receiver operating characteristic curve (AUC) was 0.743 (95%CI: 0.704–0.781; p < 0.001), indicating that our logistic regression model had significant clinical usefulness.Conclusions: We analyzed the effect of MVI on the prognosis in HCC and evaluated the risk factors for MVI, which could be helpful in making decisions regarding patients with a high risk of recurrence.

scholarly journals The effects of several postoperative adjuvant therapies for hepatocellular carcinoma patients with microvascular invasion after curative resection: a systematic review and meta-analysis

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jiarui Yang ◽  
Hao Liang ◽  
Kunpeng Hu ◽  
Zhiyong Xiong ◽  
Mingbo Cao ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Conservative Treatment ◽  
Curative Resection ◽  
Postoperative Radiotherapy ◽  
Meta Analysis ◽  
Microvascular Invasion ◽  
Cochrane Library ◽  
Conservative Group ◽  
Adjuvant Therapies ◽  
Significant Difference

Abstract Background For patients with hepatocellular carcinoma (HCC) with microvascular invasion (MVI) after curative resection, the effects of various postoperative adjuvant therapies are not summarized in detail, and the comparison between the effects of various adjuvant therapies is still unclear. Thus, we collected existing studies on postoperative adjuvant therapies for patients with HCC with MVI after curative resection and analyzed the effects of various adjuvant therapies. Method We collected all studies on postoperative adjuvant therapy for patients with HCC with MVI after curative resection from PubMed, EMBASE, Cochrane Library and SinoMed ending on May 1, 2019. Overall survival (OS) and disease-free/recurrence-free survival (RFS) between each group were compared in these studies by calculating the pooled hazard ratio (HR) and 95% confidence interval (CI). All statistical analyses were assessed by two authors independently. Result A total of 13 studies were included in this study, including 824 postoperative adjuvant transarterial chemoembolization (pa-TACE) patients, 90 postoperative radiotherapy patients, 57 radiofrequency ablation (RFA)/re-resection patients, 16 sorafenib patients and 886 postoperative conservative treatment patients. The results showed that pa-TACE significantly improved OS and RFS compared with postoperative conservative treatment in patients with HCC with MVI after curative resection (HR: 0.64, 95% CI: 0.55–0.74, p < 0.001; HR: 0.70, 95% CI: 0.62–0.78, p < 0.001, respectively). There was no significant difference in OS between pa-TACE and radiotherapy in patients with HCC with MVI (HR: 1.75, 95% CI: 0.92–3.32, p = 0.087). RFS in patients with HCC with MVI after pa-TACE was worse than that after postoperative adjuvant radiotherapy (HR: 2.29, 95% CI: 1.43–3.65, p < 0.001). The prognosis of pa-TACE and RFA/re-resection in patients with MVI with recurrent HCC had no significant differences (HR: 0.65, 95% CI: 0.09–4.89, p = 0.671). Adjuvant treatments significantly improved the OS and RFS of patients compared with the postoperative conservative group (HR: 0.580, 95% CI: 0.480–0.710, p < 0.001; HR: 0.630, 95% CI: 0.540–0.740, p < 0.001, respectively). Conclusion Compared with postoperative conservative treatment, pa-TACE, postoperative radiotherapy and sorafenib can improve the prognosis of patients with hepatocellular carcinoma with microvascular invasion after curative resection. Postoperative radiotherapy can reduce the recurrence of patients with HCC with MVI after curative resection compared with pa-TACE.

scholarly journals Combining tissue and circulating tumor DNA increases the detection rate of a CTNNB1 mutation in hepatocellular carcinoma

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Stine Karlsen Oversoe ◽  
Michelle Simone Clement ◽  
Britta Weber ◽  
Henning Grønbæk ◽  
Stephen Jacques Hamilton-Dutoit ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Mutation Rate ◽  
Detection Rate ◽  
Tumor Tissue ◽  
Circulating Tumor Dna ◽  
Treatment Modalities ◽  
Advanced Hepatocellular Carcinoma ◽  
Tissue Samples ◽  
The Impact ◽  
Tumor Dna

Abstract Background and aims Studies suggest that mutations in the CTNNB1 gene are predictive of response to immunotherapy, an emerging therapy for advanced hepatocellular carcinoma (HCC). Analysis of circulating tumor DNA (ctDNA) offers the possibility of serial non-invasive mutational profiling of tumors. Combining tumor tissue and ctDNA analysis may increase the detection rate of mutations. This study aimed to evaluate the frequency of the CTNNB1 p.T41A mutation in ctDNA and tumor samples from HCC patients and to evaluate the concordance rates between plasma and tissue. We further evaluated changes in ctDNA after various HCC treatment modalities and the impact of the CTNNB1 p.T41A mutation on the clinical course of HCC. Methods We used droplet digital PCR to analyze plasma from 95 patients and the corresponding tumor samples from 37 patients during 3 years follow up. Results In tumor tissue samples, the mutation rate was 8.1% (3/37). In ctDNA from HCC patients, the CTNNB1 mutation rate was 9.5% (9/95) in the pre-treatment samples. Adding results from plasma analysis to the subgroup of patients with available tissue samples, the mutation detection rate increased to 13.5% (5/37). There was no difference in overall survival according to CTNNB1 mutational status. Serial testing of ctDNA suggested a possible clonal evolution of HCC or arising multicentric tumors with separate genetic profiles in individual patients. Conclusion Combining analysis of ctDNA and tumor tissue increased the detection rate of CTNNB1 mutation in HCC patients. A liquid biopsy approach may be useful in a tailored therapy of HCC.

The Efficacy of Etoposide-Based Therapy in Adult Secondary Hemophagocytic Lymphohistiocytosis

2021 ◽  
pp. 1-9
Author(s):  
Leonard Naymagon ◽  
Douglas Tremblay ◽  
John Mascarenhas
Keyword(s):  
Hemophagocytic Lymphohistiocytosis ◽  
Proportional Hazards ◽  
Multivariable Analysis ◽  
Cox Proportional Hazards ◽  
Rank Test ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Significant Difference ◽  
The Impact

Data supporting the use of etoposide-based therapy in hemophagocytic lymphohistiocytosis (HLH) arise largely from pediatric studies. There is a lack of comparable data among adult patients with secondary HLH. We conducted a retrospective study to assess the impact of etoposide-based therapy on outcomes in adult secondary HLH. The primary outcome was overall survival. The log-rank test was used to compare Kaplan-Meier distributions of time-to-event outcomes. Multivariable Cox proportional hazards modeling was used to estimate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs). Ninety adults with secondary HLH seen between January 1, 2009, and January 6, 2020, were included. Forty-two patients (47%) received etoposide-based therapy, while 48 (53%) received treatment only for their inciting proinflammatory condition. Thirty-three patients in the etoposide group (72%) and 32 in the no-etoposide group (67%) died during follow-up. Median survival in the etoposide and no-etoposide groups was 1.04 and 1.39 months, respectively. There was no significant difference in survival between the etoposide and no-etoposide groups (log-rank <i>p</i> = 0.4146). On multivariable analysis, there was no association between treatment with etoposide and survival (HR for death with etoposide = 1.067, 95% CI: 0.633–1.799, <i>p</i> = 0.8084). Use of etoposide-based therapy was not associated with improvement in outcomes in this large cohort of adult secondary HLH patients.

scholarly journals Impact of Extrahepatic Metastases on Overall Survival in Patients with Advanced Liver Dominant Hepatocellular Carcinoma: A Subanalysis of the SORAMIC Trial

Liver Cancer ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. 771-786
Author(s):  
Kerstin Schütte ◽  
Regina Schinner ◽  
Mathias P. Fabritius ◽  
Melina Möller ◽  
Christiane Kuhl ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Median Survival ◽  
Pulmonary Metastases ◽  
Study Entry ◽  
Extrahepatic Disease ◽  
Advanced Hepatocellular Carcinoma ◽  
Significant Difference ◽  
Distant Organ ◽  
Extrahepatic Metastases ◽  
The Impact

<b><i>Introduction:</i></b> Extrahepatic spread is reported as a prognostic factor in patients with advanced hepatocellular carcinoma (HCC) receiving systemic therapy. However, clinical studies have reported conflicting results for the clinical impact of the pattern of tumor progression during treatment and the role of new extrahepatic metastases in length of survival. <b><i>Objective:</i></b> To evaluate the impact of extrahepatic metastases on survival in patients with HCC treated with sorafenib or with a combination of sorafenib and selective internal radiation treatment (SIRT). <b><i>Methods:</i></b> SORAMIC is a randomized, controlled trial comprising diagnostic, local ablation, and palliative cohorts. In the palliative cohort, patients not eligible for transarterial chemoembolization (TACE) were randomized 11:10 to SIRT plus sorafenib (SIRT + sorafenib) or sorafenib alone. This exploratory subanalysis evaluated the impact of extrahepatic metastases on survival. <b><i>Results:</i></b> In the intent-to-treat cohort, 216 patients were randomized to SIRT + sorafenib and 208 to sorafenib alone. Seventeen patients with distant organ metastases (bone, <i>n</i> = 11; adrenal glands, <i>n</i> = 5; peritoneum, <i>n</i> = 1) and 262 without distant metastases at study entry were analyzed in this substudy. Patients with (Group A) and without (Group B) distant organ metastases at study entry presented with a median survival of 11.3 and 14.8 months, respectively (<i>p</i> = 0.2807). During follow-up of patients with no organ metastases at baseline, extrahepatic disease progression occurred in 50 patients (19.1%). No statistically significant difference in survival was observed between patients without extrahepatic progression and those with new extrahepatic disease during treatment (14.8 vs. 14.9 months; <i>p</i> = 0.6483). Development of new pulmonary metastases during treatment significantly shortened median survival (7.6 vs. 15.0 months, <i>p</i> = 0.0060). <b><i>Conclusions:</i></b> This subanalysis of the SORAMIC trial suggests that in patients with liver-dominant advanced HCC, metastases to distant organs with the exception of pulmonary metastases do not in general exert a negative impact on patient prognosis. The choice of palliative treatment should incorporate a personalized analysis of the pattern of tumor distribution.

Surgical outcomes for chronic exertional compartment syndrome following improved diagnostic criteria

2019 ◽  
Vol 166 (E) ◽  
pp. e17-e20 ◽  
Author(s):  
Christopher Simpson ◽  
D Roscoe ◽  
S Hughes ◽  
D Hulse ◽  
H Guthrie
Keyword(s):  
Compartment Syndrome ◽  
Diagnostic Criteria ◽  
Clinical Symptoms ◽  
Diagnostic Testing ◽  
Rank Test ◽  
Anterior Compartment ◽  
Chronic Exertional Compartment Syndrome ◽  
Significant Difference ◽  
Exertional Compartment Syndrome ◽  
The Impact

IntroductionChronic exertional compartment syndrome (CECS) presents with pain during exercise, most commonly within the anterior compartment of the lower limb. A diagnosis is classically made from a typical history and the measurement of intramuscular compartmental pressure (IMCP) testing. Improved, more specific diagnostic criteria for IMCP testing allow clinicians to now be more certain of a diagnosis of CECS. Outcomes following surgical treatment in patients diagnosed using these more robust criteria are unknown.MethodsAll patients undergoing fasciectomy for anterior compartment CECS at a single rehabilitation unit were identified between 2014 and 2017. Wilcoxen signed-rank test was used to compare military fitness grading and paired t-test was used to compare Foot and Ankle Ability Measure, FAAM Sport Specific and Exercise-Induced LimbPain-G outcome measures, presurgery and postsurgery.ResultsThere was a significant difference in fitness grading between presurgical and postsurgical intervention (Z = −2.68, p < 0.01) with 46 % of patients improving their occupational medical grading. All secondary measures of outcome, looking at clinical symptoms, also improved.ConclusionAlmost half of the patients undergoing fasciectomy, following diagnosis using more specific criteria, will have an improvement in occupational medical grading. These outcomes represent the lower end of those reported in civilian populations. This is likely a result of a combination of factors, most notably the different diagnostic criteria followed and the more stringent criteria applied to military occupational grading, compared with civilian practice. Further work is now required to evaluate the impact of differing rehabilitation regimes on postoperative patients identified through this more specific diagnostic testing.

124Impact of intimal tracking for recanalization of CTO lesions on long-term clinical outcomes

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
S Kano ◽  
K Nasu ◽  
M Habara ◽  
T Shimura ◽  
M Yamamoto ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cox Regression ◽  
Target Lesion ◽  
Hazard Ratio ◽  
Rank Test ◽  
Total Occlusion ◽  
Significant Difference ◽  
The Impact

Abstract Background For recanalization of coronary chronic total occlusion (CTO) lesions, subintimal guidewire tracking in both antegrade and retrograde approaches are commonly used. Purpose This study aimed to assess the impact of subintimal tracking on long-term clinical outcomes after recanalization of CTO lesions. Methods Between January 2009 and December 2016, 474 CTO lesions (434patients) were successfully recanalized in our center. After guidewire crossing in a CTO lesion, those lesions were divided into intimal tracking group (84.6%, n=401) and subintimal tracking group (15.4%, n=73) according to intravascular ultrasound (IVUS) findings. Long-term clinical outcomes including death, target lesion revascularization (TLR), target vessel revascularization (TVR) were compared between the two groups. In addition, the rate of re-occlusion after successful revascularization was also evaluated. Results The median follow-up period was 4.7 years (interquartile range, 2.8–6.1). There was no significant difference of the rate of cardiac death between the two groups (intimal tracking vs. subintimal tracking: 7.0% vs. 4.1%; hazard ratio, 0.61; 95% confidence interval [CI], 0.19 to 2.00; p=0.41), TLR (14.3% vs. 16.2%; hazard ratio, 1.34; 95% CI, 0.71 to 2.53; p=0.37), and TVR (17.5% vs. 20.3%; hazard ratio, 1.27; 95% CI, 0.72 to 2.23; p=0.42). However, the rate of re-occlusion was significantly higher in the subintimal tracking group than intimal tracking group at 3-years re-occlusion (4.2% vs. 14.5%; log-rank test, p=0.002, Figure). In the multivariate COX regression, subintimal guidewire tracking was an independent predictor of re-occlusion after CTO recanalization (HR: 5.40; 95% CI: 2.11–13.80; p<0.001). Figure 1 Conclusions Subintimal guidewire tracking for recanalization of coronary CTO was associated with significantly higher incidence of target lesion re-occlusion during long-term follow-up period.

A Measure to Detect Sleep Onset Using Statistical Analysis of Spike Rhythmicity

2014 ◽  
Vol 3 (1) ◽  
pp. 27-41 ◽  
Author(s):  
B.R. Purnima ◽  
N. Sriraam ◽  
U. Krishnaswamy ◽  
K. Radhika
Keyword(s):  
Statistical Analysis ◽  
Sleep Onset ◽  
Rank Test ◽  
P Value ◽  
Sleep State ◽  
Statistical Measures ◽  
Plot Analysis ◽  
Significant Difference ◽  
Signed Rank Test ◽  
The Impact

Electroencephalogram (EEG) signals derived from polysomnography recordings play an important role in assessing the physiological and behavioral changes during onset of sleep. This paper suggests a spike rhythmicity based feature for discriminating the wake and sleep state. The polysomnography recordings are segmented into 1 second EEG patterns to ensure stationarity of the signal and four windowing scheme overlaps (0%, 50%, 60% and 75%)of EEG pattern are introduced to study the influence of the pre-processing procedure. The application of spike rhythmicity feature helps to estimate the number of spikes from the given pattern with a threshold of 25%.Then non parametric statistical analysis using Wilcoxon signed rank test is introduced to evaluate the impact of statistical measures such as mean, standard deviation, p-value and box-plot analysis under various conditions .The statistical test shows significant difference between wake and sleep with p<0.005 for the applied feature, thus demonstrating the efficiency of simple thresholding in distinguishing sleep and wake stage .

scholarly journals Controlling Nutritional Status (CONUT) Score is Associated with Overall Survival in Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Cohort Study

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1076 ◽  
Author(s):  
Shigeo Shimose ◽  
Takumi Kawaguchi ◽  
Hideki Iwamoto ◽  
Masatoshi Tanaka ◽  
Ken Miyazaki ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Nutritional Status ◽  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Rank Test ◽  
Multicenter Cohort Study ◽  
The Impact ◽  
Conut Score

We aimed to investigate the impact of the controlling nutritional status (CONUT) score, an immuno-nutritional biomarker, on the prognosis of patients with hepatocellular carcinoma (HCC) treated with lenvatinib (LEN). This retrospective study enrolled 164 patients with HCC and treated with LEN (median age 73 years, Barcelona Clinic Liver Cancer (BCLC) stage B/C 93/71). Factors associated with overall survival (OS) were evaluated using multivariate and decision tree analyses. OS was calculated using the Kaplan–Meier method and analyzed using the log–rank test. Independent factors for OS were albumin–bilirubin grade 1, BCLC stage B, and CONUT score <5 (hazard ratio (HR) 2.9, 95% confidence interval (CI) 1.58–5.31, p < 0.001). The CONUT score was the most important variable for OS, with OS rates of 70.0% and 29.0% in the low and high CONUT groups, respectively. Additionally, the median survival time was longer in the low CONUT group than in the high CONUT group (median survival time not reached vs. 11.3 months, p < 0.001). The CONUT score was the most important prognostic variable, rather than albumin–bilirubin grade and BCLC stage, in patients with HCC treated with LEN. Accordingly, immuno-nutritional status may be an important factor in the management of patients with HCC treated with LEN.

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