scholarly journals Rotavirus disease burden pre-vaccine introduction in young children in Rural Southern Mozambique, an area of high HIV prevalence

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0249714
Author(s):  
Sozinho Acácio ◽  
Tacilta Nhampossa ◽  
Llorenç Quintò ◽  
Delfino Vubil ◽  
Marcelino Garrine ◽  
...  
Keyword(s):  
Risk Factors ◽  
Disease Burden ◽  
Conditional Logistic Regression ◽  
Epidemiological Data ◽  
Daily Basis ◽  
African Countries ◽  
Severe Diarrhea ◽  
Vaccine Introduction ◽  
Rotavirus Vaccines ◽  
The Impact

Background Rotavirus vaccines have been adopted in African countries since 2009, including Mozambique (2015). Disease burden data are needed to evaluate the impact of rotavirus vaccine. We report the burden of rotavirus-associated diarrhea in Mozambique from the Global Enteric Multicenter Study (GEMS) before vaccine introduction. Methods A case-control study (GEMS), was conducted in Manhiça district, recruiting children aged 0–59 months with moderate-to-severe diarrhea (MSD) and less-severe-diarrhea (LSD) between December 2007 and November 2012; including 1–3 matched (age, sex and neighborhood) healthy community controls. Clinical and epidemiological data and stool samples (for laboratory investigation) were collected. Association of rotavirus with MSD or LSD was determined by conditional logistic regression and adjusted attributable fractions (AF) calculated, and risk factors for rotavirus diarrhea assessed. Results Overall 915 cases and 1,977 controls for MSD, and 431 cases and 430 controls for LSD were enrolled. Rotavirus positivity was 44% (217/495) for cases and 15% (160/1046) of controls, with AF = 34.9% (95% CI: 32.85–37.06) and adjusted Odds Ratio (aOR) of 6.4 p< 0.0001 in infants with MSD compared to 30% (46/155) in cases and 14% (22/154) in controls yielding AF = 18.7%, (95% CI: 12.02–25.39) and aOR = 2.8, p = 0.0011 in infants with LSD. The proportion of children with rotavirus was 32% (21/66) among HIV-positive children and 23% (128/566) among HIV-negative ones for MSD. Presence of animals in the compound (OR = 1.9; p = 0.0151) and giving stored water to the child (OR = 2.0, p = 0.0483) were risk factors for MSD; while animals in the compound (OR = 2.37, p = 0.007); not having routine access to water on a daily basis (OR = 1.53, p = 0.015) and washing hands before cooking (OR = 1.76, p = 0.0197) were risk factors for LSD. Conclusion The implementation of vaccination against rotavirus may likely result in a significant reduction of rotavirus-associated diarrhea, suggesting the need for monitoring of vaccine impact.

scholarly journals The secondary transmission pattern of COVID-19 based on contact tracing in Rwanda

2021 ◽  
Vol 6 (6) ◽  
pp. e004885
Author(s):  
Muhammed Semakula ◽  
FranÇois Niragire ◽  
Angela Umutoni ◽  
Sabin Nsanzimana ◽  
Vedaste Ndahindwa ◽  
...  
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Disease Transmission ◽  
Index Case ◽  
Conditional Logistic Regression ◽  
Contact Tracing ◽  
African Countries ◽  
Targeted Interventions ◽  
The Impact ◽  
Mapping Models

IntroductionCOVID-19 has shown an exceptionally high spread rate across and within countries worldwide. Understanding the dynamics of such an infectious disease transmission is critical for devising strategies to control its spread. In particular, Rwanda was one of the African countries that started COVID-19 preparedness early in January 2020, and a total lockdown was imposed when the country had only 18 COVID-19 confirmed cases known. Using intensive contact tracing, several infections were identified, with the majority of them being returning travellers and their close contacts. We used the contact tracing data in Rwanda for understanding the geographic patterns of COVID-19 to inform targeted interventions.MethodsWe estimated the attack rates and identified risk factors associated to COVID-19 spread. We used Bayesian disease mapping models to assess the spatial pattern of COVID-19 and to identify areas characterised by unusually high or low relative risk. In addition, we used multiple variable conditional logistic regression to assess the impact of the risk factors.ResultsThe results showed that COVID-19 cases in Rwanda are localised mainly in the central regions and in the southwest of Rwanda and that some clusters occurred in the northeast of Rwanda. Relationship to the index case, being male and coworkers are the important risk factors for COVID-19 transmission in Rwanda.ConclusionThe analysis of contact tracing data using spatial modelling allowed us to identify high-risk areas at subnational level in Rwanda. Estimating risk factors for infection with SARS-CoV-2 is vital in identifying the clusters in low spread of SARS-CoV-2 subnational level. It is imperative to understand the interactions between the index case and contacts to identify superspreaders, risk factors and high-risk places. The findings recommend that self-isolation at home in Rwanda should be reviewed to limit secondary cases from the same households and spatiotemporal analysis should be introduced in routine monitoring of COVID-19 in Rwanda for policy making decision on real time.

scholarly journals Detection of diarrhoea associated rotavirus and co-infection with diarrhoeagenic pathogens in the Littoral region of Cameroon using ELISA, RT-PCR and Luminex xTAG GPP assays

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rahinatou N. Ghapoutsa ◽  
Maurice Boda ◽  
Rashi Gautam ◽  
Valantine Ngum Ndze ◽  
Akongnwi E. Mugyia ◽  
...  
Keyword(s):  
Demographic Data ◽  
Laboratory Diagnosis ◽  
Epidemiological Studies ◽  
Sub Saharan Africa ◽  
Rt Pcr ◽  
Mortality And Morbidity ◽  
Vaccine Introduction ◽  
Littoral Region ◽  
Rotavirus Vaccines ◽  
The Impact

Abstract Background Despite the global roll-out of rotavirus vaccines (RotaTeq/Rotarix / ROTAVAC/Rotasiil), mortality and morbidity due to group A rotavirus (RVA) remains high in sub-Saharan Africa, causing 104,000 deaths and 600,000 hospitalizations yearly. In Cameroon, Rotarix™ was introduced in March 2014, but, routine laboratory diagnosis of rotavirus infection is not yet a common practice, and vaccine effectiveness studies to determine the impact of vaccine introduction have not been done. Thus, studies examining RVA prevalence post vaccine introduction are needed. The study aim was to determine RVA prevalence in severe diarrhoea cases in Littoral region, Cameroon and investigate the role of other diarrheagenic pathogens in RVA-positive cases. Methods We carried out a study among hospitalized children < 5 years of age, presenting with acute gastroenteritis in selected hospitals of the Littoral region of Cameroon, from May 2015 to April 2016. Diarrheic stool samples and socio-demographic data including immunization and breastfeeding status were collected from these participating children. Samples were screened by ELISA (ProSpecT™ Rotavirus) for detection of RVA antigen and by gel-based RT-PCR for detection of the VP6 gene. Co-infection was assessed by multiplexed molecular detection of diarrheal pathogens using the Luminex xTAG GPP assay. Results The ELISA assay detected RVA antigen in 54.6% (71/130) of specimens, with 45, positive by VP6 RT-PCR and 54, positive using Luminex xTAG GPP. Luminex GPP was able to detect all 45 VP6 RT-PCR positive samples. Co-infections were found in 63.0% (34/54) of Luminex positive RVA infections, with Shigella (35.3%; 12/34) and ETEC (29.4%; 10/34) detected frequently. Of the 71 ELISA positive RVA cases, 57.8% (41/71) were fully vaccinated, receiving two doses of Rotarix. Conclusion This study provides insight on RVA prevalence in Cameroon, which could be useful for post-vaccine epidemiological studies, highlights higher than expected RVA prevalence in vaccinated children hospitalized for diarrhoea and provides the trend of RVA co-infection with other enteric pathogens. RVA genotyping is needed to determine circulating rotavirus genotypes in Cameroon, including those causing disease in vaccinated children.

scholarly journals The malaria burden of Amerindian groups of three Venezuelan states: a descriptive study based on programmatic data

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Juan C. Gabaldón-Figueira ◽  
Carlos Chaccour ◽  
Jorge Moreno ◽  
Maria Villegas ◽  
Leopoldo Villegas
Keyword(s):  
Risk Factors ◽  
Plasmodium Falciparum ◽  
Malaria Incidence ◽  
Hot Spot ◽  
Public Health Problem ◽  
Epidemiological Data ◽  
Descriptive Study ◽  
Malaria Burden ◽  
Indigenous Groups ◽  
The Impact

Abstract Background Fifty-three percent of all cases of malaria in the Americas in 2019 came from Venezuela, where the epidemic is heavily focused south of the Orinoco river, and where most of the country’s Amerindian groups live. Although the disease is known to represent a significant public health problem among these populations, little epidemiological data exists on the subject. This study aims to provide information on malaria incidence, geospatial clustering, and risk factors associated to Plasmodium falciparum infection among these groups. Methods This is a descriptive study based on the analysis of published and unpublished programmatic data collected by Venezuelan health authorities and non-government organizations between 2014 and 2018. The Annual Parasite Index among indigenous groups (API-i) in municipalities of three states (Amazonas, Bolivar, and Sucre) were calculated and compared using the Kruskal Wallis test, risk factors for Plasmodium falciparum infection were identified via binomial logistic regression and maps were constructed to identify clusters of malaria cases among indigenous patients via Moran’s I and Getis-Ord’s hot spot analysis. Results 116,097 cases of malaria in Amerindian groups were registered during the study period. An increasing trend was observed between 2014 and 2016 but reverted in 2018. Malaria incidence remains higher than in 2014 and hot spots were identified in the three states, although more importantly in the south of Bolivar. Most cases (73.3%) were caused by Plasmodium vivax, but the Hoti, Yanomami, and Eñepa indigenous groups presented higher odds for infection with Plasmodium falciparum. Conclusion Malaria cases among Amerindian populations increased between 2014 and 2018 and seem to have a different geographic distribution than those among the general population. These findings suggest that tailored interventions will be necessary to curb the impact of malaria transmission in these groups.

scholarly journals Relation between body composition and severe diarrhea in patients treated with preoperative chemoradiation with capecitabine for rectal cancer: a single-centre cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
J. M. van Rees ◽  
W. Hartman ◽  
J. J. M. E. Nuyttens ◽  
E. Oomen-de Hoop ◽  
J. L. A. van Vugt ◽  
...  
Keyword(s):  
Risk Factors ◽  
Rectal Cancer ◽  
Body Composition ◽  
Logistic Regression ◽  
Cohort Study ◽  
Preoperative Chemoradiation ◽  
Regression Analyses ◽  
Single Centre ◽  
Severe Diarrhea ◽  
The Impact

Abstract Background Chemoradiation with capecitabine followed by surgery is standard care for locally advanced rectal cancer (LARC). Severe diarrhea is considered a dose-limiting toxicity of adding capecitabine to radiation therapy. The aim of this study was to describe the risk factors and the impact of body composition on severe diarrhea in patients with LARC during preoperative chemoradiation with capecitabine. Methods A single centre retrospective cohort study was conducted in a tertiary referral centre. All patients treated with preoperative chemoradiation with capecitabine for LARC from 2009 to 2015 were included. Patients with locally recurrent rectal cancer who received chemoradiation for the first time were included as well. Logistic regression analyses were performed to identify risk factors for severe diarrhea. Results A total of 746 patients were included. Median age was 64 years (interquartile range 57–71) and 477 patients (64%) were male. All patients received a radiation dosage of 25 × 2 Gy during a period of five weeks with either concomitant capecitabine administered on radiation days or continuously during radiotherapy. In this cohort 70 patients (9%) developed severe diarrhea. In multivariable logistic regression analyses female sex (OR: 4.42, 95% CI 2.54–7.91) and age ≥ 65 (OR: 3.25, 95% CI 1.85–5.87) were the only risk factors for severe diarrhea. Conclusions Female patients and patients aged sixty-five or older had an increased risk of developing severe diarrhea during preoperative chemoradiation therapy with capecitabine. No relation was found between body composition and severe diarrhea.

scholarly journals Estimating the burden of cardiovascular risk in community dwellers over 40 years old in South Africa, Kenya, Burkina Faso and Ghana

2021 ◽  
Vol 6 (1) ◽  
pp. e003499
Author(s):  
Ryan G Wagner ◽  
Nigel J Crowther ◽  
Lisa K Micklesfield ◽  
Palwende Romauld Boua ◽  
Engelbert A Nonterah ◽  
...  
Keyword(s):  
Risk Factors ◽  
Risk Factor ◽  
South African ◽  
Sub Saharan Africa ◽  
African Countries ◽  
Cvd Risk ◽  
Genomic Studies ◽  
Sub Saharan ◽  
Context Specific ◽  
The Impact

IntroductionCardiovascular disease (CVD) risk factors are increasing in sub-Saharan Africa. The impact of these risk factors on future CVD outcomes and burden is poorly understood. We examined the magnitude of modifiable risk factors, estimated future CVD risk and compared results between three commonly used 10-year CVD risk factor algorithms and their variants in four African countries.MethodsIn the Africa-Wits-INDEPTH partnership for Genomic studies (the AWI-Gen Study), 10 349 randomly sampled individuals aged 40–60 years from six sites participated in a survey, with blood pressure, blood glucose and lipid levels measured. Using these data, 10-year CVD risk estimates using Framingham, Globorisk and WHO-CVD and their office-based variants were generated. Differences in future CVD risk and results by algorithm are described using kappa and coefficients to examine agreement and correlations, respectively.ResultsThe 10-year CVD risk across all participants in all sites varied from 2.6% (95% CI: 1.6% to 4.1%) using the WHO-CVD lab algorithm to 6.5% (95% CI: 3.7% to 11.4%) using the Framingham office algorithm, with substantial differences in risk between sites. The highest risk was in South African settings (in urban Soweto: 8.9% (IQR: 5.3–15.3)). Agreement between algorithms was low to moderate (kappa from 0.03 to 0.55) and correlations ranged between 0.28 and 0.70. Depending on the algorithm used, those at high risk (defined as risk of 10-year CVD event >20%) who were under treatment for a modifiable risk factor ranged from 19.2% to 33.9%, with substantial variation by both sex and site.ConclusionThe African sites in this study are at different stages of an ongoing epidemiological transition as evidenced by both risk factor levels and estimated 10-year CVD risk. There is low correlation and disparate levels of population risk, predicted by different risk algorithms, within sites. Validating existing risk algorithms or designing context-specific 10-year CVD risk algorithms is essential for accurately defining population risk and targeting national policies and individual CVD treatment on the African continent.

scholarly journals The Impact of RSV-Associated Respiratory Disease on Children in Asia

2018 ◽  
Vol 14 (03) ◽  
pp. 079-088
Author(s):  
Maduja Divarathne ◽  
Rukshan Ahamed ◽  
Faseeha Noordeen
Keyword(s):  
Risk Factors ◽  
Developing Countries ◽  
Disease Burden ◽  
Heart Diseases ◽  
Epidemiological Studies ◽  
Morbidity And Mortality ◽  
Life Years ◽  
Rsv Infection ◽  
Tract Infections ◽  
The Impact

AbstractAcute respiratory tract infections (ARTIs) are leading contributors to the global infectious disease burden, which is estimated to be 112,900,000 disability adjusted life years. Viruses contribute to the etiology of ARTIs in a big way compared with other microorganisms. Since the discovery of respiratory syncytial virus (RSV) 61 years ago, the virus has been recognized as a major cause of ARTI and hospitalization in children. The morbidity and mortality attributable to RSV infection appear to be higher in infants < 3 months and in those with known risk factors such as prematurity, chronic lung, and congenital heart diseases. Crowded living conditions, exposure to tobacco smoke, and industrial or other types of air pollution also increase the risk of RSV-associated ARTI. Many epidemiological studies have been conducted in developed countries to understand the seasonal patterns and risk factors associated with RSV infections. Dearth of information on RSV-associated morbidity and mortality in Asian and developing countries indicates the need for regional reviews to evaluate RSV-associated disease burden in these countries. Epidemiological studies including surveillance is the key to track the disease burden including risk factors, seasonality, morbidity, and mortality associated with RSV infection in these countries. These data will contribute to improve the clinical diagnosis and plan preventive strategies in resource-limited developing countries.

scholarly journals Ruminant and industrial sources of trans-fat and cardiovascular and diabetic diseases

2011 ◽  
Vol 24 (1) ◽  
pp. 111-117 ◽  
Author(s):  
Anne-Laure Tardy ◽  
Béatrice Morio ◽  
Jean-Michel Chardigny ◽  
Corinne Malpuech-Brugère
Keyword(s):  
Risk Factors ◽  
Type 2 Diabetes ◽  
Vaccenic Acid ◽  
Biological Effects ◽  
Epidemiological Data ◽  
Cvd Risk ◽  
Industrial Sources ◽  
Ruminant Meat ◽  
The Impact

The various positional isomers of oleic acid (18 : 1Δ9c or 9c-18 : 1) may have distinct biological effects. Detrimental effects of consumption of industrial trans-fatty acids (TFA) (elaidic acid; 18 : 1Δ9t) from partially hydrogenated vegetable oils on CVD risk factors are well documented. In addition, epidemiological data suggest that chronic consumption of industrial sources of TFA could alter insulin sensitivity and predispose for type 2 diabetes. However, intervention studies on this issue have remained inconclusive. Moreover, very little information is available on the effect of natural sources of TFA (vaccenic acid; 18 : 1Δ11t) coming from dairy products and ruminant meat on the development of CVD and type 2 diabetes. The review focuses on the impact of the consumption of ruminant TFA in relation to cardiovascular risk factors, inflammation and type 2 diabetes.

scholarly journals Main causes of complicated COVID-19 in patients with diabetes mellitus

2021 ◽  
Vol 17 (4) ◽  
pp. 23-31
Author(s):  
O.A. Halushko ◽  
O.A. Loskutov ◽  
M.A. Trishchynska ◽  
I.A. Kuchynska ◽  
M.V. Boliuk
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Epidemiological Data ◽  
Current Treatment ◽  
World Health ◽  
Chronic Obstructive ◽  
Team Approach ◽  
Patients With Diabetes ◽  
Complicated Course ◽  
The Impact

Background. Since December 2019, the new coronavirus disease 2019 (COVID-19) has been marching confidently and aggressively across the planet. On March 11, 2020, the World Health Organization has declared COVID-19 a pandemic. Among the risk factors for the development and severe course of COVID-19, there are old age, arterial hypertension, diabetes mellitus, chronic obstructive pulmonary disease, cardiovascular and cerebrovascular diseases. However, recently, based on the epidemiological data obtained, diabetes mellitus is no longer considered a risk factor for infection with SARS-CoV-2, but the presence of concomitant diabetes is associated with a more severe course of COVID-19 and deterioration in treatment outcomes. What is the reason for the complicated course of COVID-19 in patients with diabetes mellitus? The need to answer this question led to the conduction of this study. The purpose was to determine the causes of complicated course of COVID-19 in patients with diabetes mellitus. Material and methods. We searched for publications using the search engines PubMed and Google Scholar by keywords: COVID-19, diabetes mellitus, hyperglycemia, carbohydrate metabolism disorders, complications. Results. The review of the scientific literature considers the main causes and pathogenetic mechanisms of COVID-19 complications in patients with diabetes mellitus. Groups of factors that worsen the course of the diseases have been identified, and it has been proven that current treatment of COVID-19 in patients with diabetes mellitus should take into account all available risk factors and include a multidisciplinary team approach involving specialists in emergency medicine, endocrinology, infectious diseases, respiratory support, nutritional science and rehabilitation. Conclusions. The main causes that worsen the course of COVID-19 in patients with diabetes mellitus are: 1) features of diabetes itself and the interaction of diabetes and COVID-19; 2) the impact of certain drugs used in the treatment of both diseases; 3) shortcomings in the organization of treatment and care of patients. The main factor that is crucial in the management of these patients is the normalization of blood glucose levels and carbohydrate balance, which must be achieved by all possible means.

scholarly journals Neurological diseases in Peru: a systematic analysis of the global burden disease study

2020 ◽  
Vol 78 (5) ◽  
pp. 282-289
Author(s):  
Carlos ALVA-DÍAZ ◽  
Andrely HUERTA-ROSARIO ◽  
Kevin PACHECO-BARRIOS ◽  
Roberto A. MOLINA ◽  
Alba NAVARRO-FLORES ◽  
...  
Keyword(s):  
Disease Burden ◽  
Neurological Diseases ◽  
Age Groups ◽  
Epidemiological Data ◽  
Global Burden ◽  
Years Of Life Lost ◽  
Systematic Analysis ◽  
Life Years ◽  
Disease Study ◽  
The Impact

ABSTRACT Background: Disease burden indicators assess the impact of disease on a population. They integrate mortality and disability in a single indicator. This allows setting priorities for health services and focusing resources. Objective: To analyze the burden of neurological diseases in Peru from 1990-2015. Methods: A descriptive study that used the epidemiological data published by the Institute for Health Metrics and Evaluation of Global Burden of Diseases from 1990 to 2015. Disease burden was measured using disability-adjusted life years (DALY) and their corresponding 95% uncertainty intervals (UIs), which results from the addition of the years of life lost (YLL) and years lived with disability (YLD). Results: The burden of neurological diseases in Peru were 9.06 and 10.65%, in 1990 and 2015, respectively. In 2015, the main causes were migraine, cerebrovascular disease (CVD), neonatal encephalopathy (NE), and Alzheimer’s disease and other dementias (ADD). This last group and nervous system cancer (NSC) increased 157 and 183% of DALY compared to 1990, respectively. Young population (25 to 44 years old) and older (>85 years old) were the age groups with the highest DALY. The neurological diseases produced 11.06 and 10.02% of the national YLL (CVD as the leading cause) and YLD (migraine as the main cause), respectively. Conclusion: The burden of disease (BD) increased by 1.6% from 1990 to 2015. The main causes were migraine, CVD, and NE. ADD and NSC doubled the DALY in this period. These diseases represent a significant cause of disability attributable to the increase in the life expectancy of our population among other factors. Priority actions should be taken to prevent and treat these causes.

scholarly journals Tracking changes in reporting of epidemiological data during the COVID-19 pandemic in Southeast Asia: an observational study during the first wave

2020 ◽  
Author(s):  
Arianna Maever L. Amit ◽  
Veincent Christian F. Pepito ◽  
Bernardo Gutierrez ◽  
Thomas Rawson
Keyword(s):  
Southeast Asia ◽  
Data Sharing ◽  
Demographic Data ◽  
Epidemiological Data ◽  
Daily Basis ◽  
Design Data ◽  
Individual Level ◽  
Level Data ◽  
Reporting Systems ◽  
The Impact

SummaryBackgroundWhen a new pathogen emerges, consistent case reporting is critical for public health surveillance. Tracking cases geographically and over time is key for understanding the spread of an infectious disease and how to effectively design interventions to contain and mitigate an epidemic. In this paper we describe the reporting systems on COVID-19 in Southeast Asia during the first wave in 2020, and highlight the impact of specific reporting methods.MethodsWe reviewed key epidemiological variables from various sources including a regionally comprehensive dataset, national trackers, dashboards, and case bulletins for 11 countries during the first wave of the epidemic in Southeast Asia. We recorded timelines of shifts in epidemiological reporting systems. We further described the differences in how epidemiological data are reported across countries and timepoints, and the accessibility of epidemiological data.FindingsOur findings suggest that countries in Southeast Asia generally reported precise and detailed epidemiological data during the first wave of the COVID-19 pandemic. However, changes in reporting were frequent and varied across data and countries. Changes in reporting rarely occurred for demographic data such as age and sex, while reporting shifts for geographic and temporal data were frequent. We also found that most countries provided COVID-19 individual-level data daily using HTML and PDF, necessitating scraping and extraction before data could be used in analyses.InterpretationCountries have different reporting systems and different capacities for maintaining consistent reporting of epidemiological data. As the pandemic progresses, governments may also change their priorities in data sharing. Our study thus highlights the importance of more nuanced analyses of epidemiological data of COVID-19 within and across countries because of the frequent shifts in reporting. Further, most countries provide data on a daily basis but not always in a readily usable format. As governments continue to respond to the impacts of COVID-19 on health and the economy, data sharing also needs to be prioritised given its foundational role in policymaking, and the implementation and evaluation of interventions.FundingThe work was supported through an Engineering and Physical Sciences Research Council (EPSRC) (https://epsrc.ukri.org/) Systems Biology studentship award (EP/G03706X/1) to TR. This project was also supported in part by the Oxford Martin School.The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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