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  1. Article ; Online: Development and evaluation of standardized pregnancy identification and trimester distribution algorithms in U.S. IBM MarketScan® Commercial and Medicaid data.

    Sumner, Kelsey M / Ehlinger, Anna / Georgiou, Mary E / Wurst, Keele E

    Birth defects research

    2021  Volume 113, Issue 19, Page(s) 1357–1367

    Abstract: Objectives: Creation of new algorithms to identify pregnancies in automated health care claims databases is of public health importance, as it allows us to learn more about medication use and safety in a vulnerable population. Previous algorithms were ... ...

    Abstract Objectives: Creation of new algorithms to identify pregnancies in automated health care claims databases is of public health importance, as it allows us to learn more about medication use and safety in a vulnerable population. Previous algorithms were largely created using international classification of disease codes, but despite the U.S. code transition in 2015, few algorithms are available with the latest ICD-10-CM codes.
    Methods: Using U.S. IBM MarketScan® Commercial Claims and Encounters and Multi-State Medicaid databases for women aged 10-64 years during 2014 and 2016, two pregnancy algorithms (ICD-9-CM and ICD-10-CM) were created using expert clinical review. The algorithms were evaluated by assessing the distribution of pregnancy outcomes (live birth and pregnancy losses) within each time-based cohort and the ability of the algorithms to identify select medication use during pregnancy. Medication exposure, demographics, comorbidities, and pregnancy outcomes were compared to published literature estimates for the two time periods.
    Results: For the IBM MarketScan® Commercial database, the algorithms identified 687,228 pregnancies in 2014 and 444,293 in 2016. In the IBM MarketScan® Medicaid database, 389,132 pregnancies in 2014 and 406,418 in 2016 were identified. Percentages of most pregnancy outcomes identified using the algorithms were similar to national data sources; however, percentages of preterm births and pregnancy losses were not comparable. Most medication use estimates from the algorithms were similar to or higher than published estimates.
    Conclusions: By incorporating the latest ICD-10-CM codes, the new algorithms provide more complete estimates of medication use during pregnancy than algorithms using the outdated codes.
    MeSH term(s) Algorithms ; Cohort Studies ; Databases, Factual ; Female ; Humans ; Infant, Newborn ; Medicaid ; Pregnancy ; Pregnancy Outcome/epidemiology ; United States
    Language English
    Publishing date 2021-09-15
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2104792-3
    ISSN 2472-1727
    ISSN (online) 2472-1727
    DOI 10.1002/bdr2.1954
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  2. Article ; Online: Plasmodium falciparum Genetic Diversity in Coincident Human and Mosquito Hosts.

    Lapp, Zena / Obala, Andrew A / Abel, Lucy / Rasmussen, David A / Sumner, Kelsey M / Freedman, Elizabeth / Taylor, Steve M / Prudhomme-O'Meara, Wendy

    mBio

    2022  Volume 13, Issue 5, Page(s) e0227722

    Abstract: Population genetic diversity of Plasmodium falciparum antigenic loci is high despite large bottlenecks in population size during the parasite life cycle. The prevalence of genetically distinct haplotypes at these loci, while well characterized in humans, ...

    Abstract Population genetic diversity of Plasmodium falciparum antigenic loci is high despite large bottlenecks in population size during the parasite life cycle. The prevalence of genetically distinct haplotypes at these loci, while well characterized in humans, has not been thoroughly compared between human and mosquito hosts. We assessed parasite haplotype prevalence, diversity, and evenness using human and mosquito P. falciparum infections collected from the same households during a 14-month longitudinal cohort study using amplicon deep sequencing of two antigenic gene fragments (
    MeSH term(s) Animals ; Humans ; Culicidae/parasitology ; Genetic Variation ; Longitudinal Studies ; Malaria, Falciparum/parasitology ; Plasmodium falciparum/genetics
    Language English
    Publishing date 2022-09-08
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 2557172-2
    ISSN 2150-7511 ; 2161-2129
    ISSN (online) 2150-7511
    ISSN 2161-2129
    DOI 10.1128/mbio.02277-22
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Anti-SARS-CoV-2 Antibody Levels Associated with COVID-19 Protection in Outpatients Tested for SARS-CoV-2, US Flu VE Network, October 2021-June 2022.

    Sumner, Kelsey M / Yadav, Ruchi / Noble, Emma K / Sandford, Ryan / Joshi, Devyani / Tartof, Sara Y / Wernli, Karen J / Martin, Emily T / Gaglani, Manjusha / Zimmerman, Richard K / Talbot, H Keipp / Grijalva, Carlos G / Belongia, Edward A / Chung, Jessie R / Rogier, Eric / Coughlin, Melissa M / Flannery, Brendan

    The Journal of infectious diseases

    2024  

    Abstract: Background: We assessed associations between binding antibody (bAb) concentration <5 days of symptom onset and testing positive for COVID-19 among patients in a test-negative study.: Methods: From October 2021─June 2022, study sites in seven states ... ...

    Abstract Background: We assessed associations between binding antibody (bAb) concentration <5 days of symptom onset and testing positive for COVID-19 among patients in a test-negative study.
    Methods: From October 2021─June 2022, study sites in seven states enrolled patients aged ≥6 months presenting with acute respiratory illness. Respiratory specimens were tested for SARS-CoV-2. In blood specimens, we measured concentrations of anti-SARS-CoV-2 antibodies against the ancestral strain spike protein receptor binding domain (RBD) and nucleocapsid (N) antigens in standardized binding antibody units (BAU/mL). Percent change in odds of COVID-19 by increasing anti-RBD bAb was estimated using logistic regression as (1-adjusted odds ratio of COVID-19)x100, adjusting for COVID-19 mRNA vaccine doses, age, site, and high-risk exposure.
    Results: Out of 2,018 symptomatic patients, 662 (33%) tested positive for acute SARS-CoV-2 infection. Geometric mean RBD bAb were lower among COVID-19 cases than SARS-CoV-2 test-negative patients during both the Delta-predominant (112 vs. 498 BAU/mL) and Omicron-predominant (823 vs. 1,189 BAU/mL) periods. Acute phase ancestral spike RBD bAb associated with 50% lower odds of COVID-19 were 1,968 BAU/mL against Delta and 3,375 BAU/mL against Omicron; thresholds may differ in other laboratories.
    Conclusion: During acute illness, antibody concentrations against ancestral spike RBD were associated with protection against COVID-19.
    Language English
    Publishing date 2024-02-23
    Publishing country United States
    Document type Journal Article
    ZDB-ID 3019-3
    ISSN 1537-6613 ; 0022-1899
    ISSN (online) 1537-6613
    ISSN 0022-1899
    DOI 10.1093/infdis/jiae090
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  4. Article ; Online: A model for human and animal data integration: Weight of evidence strategy.

    Wurst, Keele E / Sumner, Kelsey M / Stanislaus, Dinesh / Powell, Marcy / Cunnington, Marianne

    Birth defects research

    2020  Volume 112, Issue 18, Page(s) 1505–1512

    Abstract: Background: Integration of animal and human data to assess potential risks of the use of medications in pregnancy is important. A qualitative weight of evidence process enables all available evidence to be considered in a consistent, systematic manner.!# ...

    Abstract Background: Integration of animal and human data to assess potential risks of the use of medications in pregnancy is important. A qualitative weight of evidence process enables all available evidence to be considered in a consistent, systematic manner.
    Methods: We aim to describe the weight of evidence methodology utilized by the authors, a summary of which was presented at the 59th Annual Meeting of the Teratology Society entitled "Integration of Human and Animal Data to Inform Medication Use in Pregnant Women." The qualitative weight of evidence process evaluates data that inform on a potential relationship between an adverse pregnancy outcome and a medication exposure. An interdisciplinary panel evaluates all available human and animal data related to the question of interest. Study quality assessments of both human and animal data are incorporated. The evaluation assesses gaps in the data from the following areas: (a) strength, (b) specificity, (c) consistency, (d) dose response relationship, (e) methodological considerations, and (f) biological plausibility for the potential association of interest.
    Results: The panel integrates all the information to arrive at an assessment of the evidence and provides recommendations, which may include obtaining more specific information. We provide examples of how the authors apply this process at a pharmaceutical company for evaluation of potential postmarketing safety issues regarding medications and pregnancy outcomes.
    Conclusions: This weight of evidence method improves the ability to integrate published literature and other data sources to assess the potential risks of medication use in pregnant women and inform future drug safety studies.
    MeSH term(s) Animals ; Female ; Humans ; Pregnancy ; Pregnancy Complications ; Pregnancy Outcome
    Language English
    Publishing date 2020-08-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2104792-3
    ISSN 2472-1727
    ISSN (online) 2472-1727
    DOI 10.1002/bdr2.1775
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  5. Article ; Online: Symptomatic malaria enhances protection from reinfection with homologous Plasmodium falciparum parasites.

    Markwalter, Christine F / Petersen, Jens E V / Zeno, Erica E / Sumner, Kelsey M / Freedman, Elizabeth / Mangeni, Judith N / Abel, Lucy / Obala, Andrew A / Prudhomme-O'Meara, Wendy / Taylor, Steve M

    PLoS pathogens

    2023  Volume 19, Issue 6, Page(s) e1011442

    Abstract: A signature remains elusive of naturally-acquired immunity against Plasmodium falciparum. We identified P. falciparum in a 14-month cohort of 239 people in Kenya, genotyped at immunogenic parasite targets expressed in the pre-erythrocytic ( ... ...

    Abstract A signature remains elusive of naturally-acquired immunity against Plasmodium falciparum. We identified P. falciparum in a 14-month cohort of 239 people in Kenya, genotyped at immunogenic parasite targets expressed in the pre-erythrocytic (circumsporozoite protein, CSP) and blood (apical membrane antigen 1, AMA-1) stages, and classified into epitope type based on variants in the DV10, Th2R, and Th3R epitopes in CSP and the c1L region of AMA-1. Compared to asymptomatic index infections, symptomatic malaria was associated with reduced reinfection by parasites bearing homologous CSP-Th2R (adjusted hazard ratio [aHR]:0.63; 95% CI:0.45-0.89; p = 0.008) CSP-Th3R (aHR:0.71; 95% CI:0.52-0.97; p = 0.033), and AMA-1 c1L (aHR:0.63; 95% CI:0.43-0.94; p = 0.022) epitope types. The association of symptomatic malaria with reduced hazard of homologous reinfection was strongest for rare epitope types. Symptomatic malaria provides more durable protection against reinfection with parasites bearing homologous epitope types. The phenotype represents a legible molecular epidemiologic signature of naturally-acquired immunity by which to identify new antigen targets.
    MeSH term(s) Animals ; Plasmodium falciparum/metabolism ; Parasites ; Reinfection ; Protozoan Proteins/metabolism ; Malaria/parasitology ; Malaria, Falciparum/parasitology ; Antigens, Protozoan ; Epitopes/genetics ; Malaria Vaccines ; Antibodies, Protozoan/metabolism
    Chemical Substances Protozoan Proteins ; Antigens, Protozoan ; Epitopes ; Malaria Vaccines ; Antibodies, Protozoan
    Language English
    Publishing date 2023-06-12
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2205412-1
    ISSN 1553-7374 ; 1553-7374
    ISSN (online) 1553-7374
    ISSN 1553-7374
    DOI 10.1371/journal.ppat.1011442
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  6. Article: Symptomatic malaria enhances protection from reinfection with homologous

    Markwalter, Christine F / Petersen, Jens E V / Zeno, Erica E / Sumner, Kelsey M / Freedman, Elizabeth / Mangeni, Judith N / Abel, Lucy / Obala, Andrew A / Prudhomme-O'Meara, Wendy / Taylor, Steve M

    medRxiv : the preprint server for health sciences

    2023  

    Abstract: A signature remains elusive of naturally-acquired immunity ... ...

    Abstract A signature remains elusive of naturally-acquired immunity against
    Language English
    Publishing date 2023-01-05
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2023.01.04.23284198
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  7. Article ; Online: Risk factors for infection with influenza A(H3N2) virus on a US university campus, October-November 2021.

    Lewis, Nathaniel M / Delahoy, Miranda J / Sumner, Kelsey M / Lauring, Adam S / Bendall, Emily E / Mortenson, Lindsey / Edwards, Elizabeth / Stamper, Aleksandra / Flannery, Brendan / Martin, Emily T

    Influenza and other respiratory viruses

    2023  Volume 17, Issue 5, Page(s) e13151

    Abstract: Background: Knowledge of the specific dynamics of influenza introduction and spread in university settings is limited.: Methods: Persons with acute respiratory illness symptoms received influenza testing by molecular assay during October 6-November ... ...

    Abstract Background: Knowledge of the specific dynamics of influenza introduction and spread in university settings is limited.
    Methods: Persons with acute respiratory illness symptoms received influenza testing by molecular assay during October 6-November 23, 2022. Viral sequencing and phylogenetic analysis were conducted on nasal swab samples from case-patients. Case-control analysis of a voluntary survey of persons tested was used to identify factors associated with influenza; logistic regression was conducted to calculate odds ratios and 95% CIs. A subset of case-patients tested during the first month of the outbreak was interviewed to identify sources of introduction and early spread.
    Results: Among 3268 persons tested, 788 (24.1%) tested positive for influenza; 744 (22.8%) were included in the survey analysis. All 380 sequenced specimens were influenza A (H3N2) virus clade 3C.2a1b.2a.2, suggesting rapid transmission. Influenza (OR [95% CI]) was associated with indoor congregate dining (1.43 [1.002-2.03]), attending large gatherings indoors (1.83 [1.26-2.66]) or outdoors (2.33 [1.64-3.31]), and varied by residence type (apartment with ≥1 roommate: 2.93 [1.21-7.11], residence hall room alone: 4.18 [1.31-13.31], or with roommate: 6.09 [2.46-15.06], or fraternity/sorority house: 15.13 [4.30-53.21], all compared with single-dwelling apartment). Odds of influenza were lower among persons who left campus for ≥1 day during the week before their influenza test (0.49 [0.32-0.75]). Almost all early cases reported attending large events.
    Conclusions: Congregate living and activity settings on university campuses can lead to rapid spread of influenza following introduction. Isolating following a positive influenza test or administering antiviral medications to exposed persons may help mitigate outbreaks.
    MeSH term(s) Humans ; Influenza, Human/prevention & control ; Influenza A virus ; Influenza A Virus, H3N2 Subtype ; Phylogeny ; Universities ; Risk Factors
    Language English
    Publishing date 2023-05-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 2274538-5
    ISSN 1750-2659 ; 1750-2640
    ISSN (online) 1750-2659
    ISSN 1750-2640
    DOI 10.1111/irv.13151
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  8. Article ; Online: Knowledge, attitudes, and practices associated with frequent influenza vaccination among healthcare personnel in Peru, 2016─2018.

    Sumner, Kelsey M / Duca, Lindsey M / Arriola, Carmen Sofia / Neyra, Joan / Soto, Giselle / Romero, Candice / Tinoco, Yeny / Nogareda, Francisco / Matos, Eduardo / Chavez, Victor / Castillo, Maria / Bravo, Eduar / Castro, Juan / Thompson, Mark / Azziz-Baumgartner, Eduardo

    Vaccine: X

    2023  Volume 14, Page(s) 100314

    Abstract: Introduction: Despite a government-subsidized vaccination program, healthcare personnel (HCP) influenza vaccination uptake remains low in Peru. Using three years of cross-sectional surveys and an additional five years of prior vaccination history of HCP ...

    Abstract Introduction: Despite a government-subsidized vaccination program, healthcare personnel (HCP) influenza vaccination uptake remains low in Peru. Using three years of cross-sectional surveys and an additional five years of prior vaccination history of HCP in Peru, we explored HCP knowledge, attitudes, and practices (KAP) of influenza illness and its impact on vaccination frequency.
    Methods: In 2016, the Estudio Vacuna de Influenza Peru (VIP) cohort was initiated in Lima, Peru, which collected information about HCP KAP and influenza vaccination history from 2011─2018. HCP were classified by their 8-year influenza vaccination history as never (0 years), infrequently (1─4 years), or frequently (5─8 years) vaccinated. Logistic regression models were used to describe KAP associated with frequent compared to infrequent influenza vaccination, adjusted for each HCP's healthcare workplace, age, sex, preexisting medical conditions, occupation, and length of time providing direct patient care.
    Results: From 2016─2018, 5131 HCP were recruited and 3120 fully enrolled in VIP; 2782 consistently reported influenza vaccination status and became our analytic sample. From 2011─2018, 14.3% of HCP never, 61.4% infrequently, and 24.4% frequently received influenza vaccines. Compared to HCP who were infrequently vaccinated, frequently vaccinated HCP were more likely to believe they were susceptible to influenza (adjusted odds ratio [aOR]:1.49, 95% confidence interval [CI]:1.22─1.82), perceived vaccination to be effective (aOR:1.92, 95%CI:1.59─2.32), were knowledgeable about influenza and vaccination (aOR:1.37, 95%CI:1.06─1.77), and believed vaccination had emotional benefits like reduced regret or anger if they became ill with influenza (aOR:1.96, 95%CI:1.60─2.42). HCP who reported vaccination barriers like not having time or a convenient place to receive vaccines had reduced odds of frequent vaccination (aOR:0.74, 95%CI:0.61─0.89) compared to those without reported barriers.
    Conclusion: Few HCP frequently received influenza vaccines during an eight-year period. To increase HCP influenza vaccination in middle-income settings like Peru, campaigns could strengthen influenza risk perception, vaccine knowledge, and accessibility.
    Language English
    Publishing date 2023-05-12
    Publishing country England
    Document type Journal Article
    ISSN 2590-1362
    ISSN (online) 2590-1362
    DOI 10.1016/j.jvacx.2023.100314
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  9. Article ; Online: Avian influenza A(H5) virus circulation in live bird markets in Vietnam, 2017-2022.

    Nguyen, Diep T / Sumner, Kelsey M / Nguyen, Thoa T M / Phan, Minh Q / Hoang, Tien M / Vo, Chuong D / Nguyen, Tho D / Nguyen, Phuong T / Yang, Genyan / Jang, Yunho / Jones, Joyce / Olsen, Sonja J / Gould, Philip L / Nguyen, Long V / Davis, Charles Todd

    Influenza and other respiratory viruses

    2023  Volume 17, Issue 12, Page(s) e13245

    Abstract: Background: Highly pathogenic avian influenza A(H5) human infections are a global concern, with many A(H5) human cases detected in Vietnam, including a case in October 2022. Using avian influenza virus surveillance from March 2017-September 2022, we ... ...

    Abstract Background: Highly pathogenic avian influenza A(H5) human infections are a global concern, with many A(H5) human cases detected in Vietnam, including a case in October 2022. Using avian influenza virus surveillance from March 2017-September 2022, we described the percent of pooled samples that were positive for avian influenza A, A(H5), A(H5N1), A(H5N6), and A(H5N8) viruses in live bird markets (LBMs) in Vietnam.
    Methods: Monthly at each LBM, 30 poultry oropharyngeal swab specimens and five environmental samples were collected. Samples were pooled in groups of five and tested for influenza A, A(H5), A(H5N1), A(H5N6), and A(H5N8) viruses by real-time reverse-transcription polymerase chain reaction. Trends in the percent of pooled samples that were positive for avian influenza were summarized by LBM characteristics and time and compared with the number of passively detected avian influenza outbreaks using Spearman's rank correlation.
    Results: A total of 25,774 pooled samples were collected through active surveillance at 167 LBMs in 24 provinces; 36.9% of pooled samples were positive for influenza A, 3.6% A(H5), 1.9% A(H5N1), 1.1% A(H5N6), and 0.2% A(H5N8). Influenza A(H5) viruses were identified January-December and at least once in 91.7% of sampled provinces. In 246 A(H5) outbreaks in poultry; 20.3% were influenza A(H5N1), 60.2% A(H5N6), and 19.5% A(H5N8); outbreaks did not correlate with active surveillance.
    Conclusions: In Vietnam, influenza A(H5) viruses were detected by active surveillance in LBMs year-round and in most provinces sampled. In addition to outbreak reporting, active surveillance for A(H5) viruses in settings with high potential for animal-to-human spillover can provide situational awareness.
    MeSH term(s) Animals ; Humans ; Influenza, Human/epidemiology ; Influenza in Birds/epidemiology ; Vietnam/epidemiology ; Influenza A Virus, H5N1 Subtype/genetics ; Disease Outbreaks ; Influenza A Virus, H5N8 Subtype ; Influenza A virus/genetics
    Language English
    Publishing date 2023-12-27
    Publishing country England
    Document type Journal Article
    ZDB-ID 2274538-5
    ISSN 1750-2659 ; 1750-2640
    ISSN (online) 1750-2659
    ISSN 1750-2640
    DOI 10.1111/irv.13245
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  10. Article: Anti-SARS-CoV-2 Antibody Levels Associated with COVID-19 Protection in Outpatients Tested for SARS-CoV-2, US Flu VE Network, October 2021-June 2022.

    Sumner, Kelsey M / Yadav, Ruchi / Noble, Emma K / Sandford, Ryan / Joshi, Devyani / Tartof, Sara Y / Wernli, Karen J / Martin, Emily T / Gaglani, Manjusha / Zimmerman, Richard K / Talbot, H Keipp / Grijalva, Carlos G / Chung, Jessie R / Rogier, Eric / Coughlin, Melissa M / Flannery, Brendan

    medRxiv : the preprint server for health sciences

    2023  

    Abstract: Background: We assessed the association between antibody concentration ≤5 days of symptom onset and COVID-19 illness among patients enrolled in a test-negative study.: Methods: From October 2021-June 2022, study sites in seven states enrolled and ... ...

    Abstract Background: We assessed the association between antibody concentration ≤5 days of symptom onset and COVID-19 illness among patients enrolled in a test-negative study.
    Methods: From October 2021-June 2022, study sites in seven states enrolled and tested respiratory specimens from patients of all ages presenting with acute respiratory illness for SARS-CoV-2 infection using rRT-PCR. In blood specimens, we measured concentration of anti-SARS-CoV-2 antibodies against the ancestral strain spike protein receptor binding domain (RBD) and nucleocapsid (N) antigens in standardized binding antibody units (BAU/mL). Percent reduction in odds of symptomatic COVID-19 by anti-RBD antibody was estimated using logistic regression modeled as (1-adjusted odds ratio of COVID-19)×100, adjusting for COVID-19 vaccination status, age, site, and high-risk exposure.
    Results: A total of 662 (33%) of 2,018 symptomatic patients tested positive for acute SARS-CoV-2 infection. During the Omicron-predominant period, geometric mean anti-RBD binding antibody concentrations measured 823 BAU/mL (95%CI:690-981) among COVID-19 case-patients versus 1,189 BAU/mL (95%CI:1,050-1,347) among SARS-CoV-2 test-negative patients. In the adjusted logistic regression, increasing levels of anti-RBD antibodies were associated with reduced odds of COVID-19 for both Delta and Omicron infections.
    Conclusion: Higher anti-RBD antibodies in patients were associated with protection against symptomatic COVID-19 during emergence of SARS-CoV-2 Delta and Omicron variants.
    Language English
    Publishing date 2023-09-23
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2023.09.21.23295919
    Database MEDical Literature Analysis and Retrieval System OnLINE

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