C Libersa

University of Lille Nord de France, Lille, Nord-Pas-de-Calais, France

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Publications (114)362.13 Total impact

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    ABSTRACT: We examined the association of physical activity (PA), cardiovascular fitness (CVF) and fatness with total homocysteine (tHcy) concentrations in European adolescents. The present study comprised 713 European adolescents aged 14.8±1.2 y (females 55.3%) from the multicenter HELENA cross-sectional study. PA was assessed through accelerometry, CVF by the 20-m shuttle run test, and body fat by skinfold thicknesses with the Slaughter equation. Plasma folate, cobalamin, and tHcy concentrations were measured. To examine the association of tHcy with PA, CVF, and fatness after controlling for a set of confounders including age, maturity, folate, cobalamin, creatinine, smoking, supplement use, and methylenetetrahydrofolate reductase 677 genotype (CC 47%, CT 43%, TT 10%), bivariate correlations followed by multiple regression models were performed. In the bivariate correlation analysis, tHcy concentrations were slightly negatively correlated (p<0.0 5) with CVF in females (measured both by stages: r=-0.118 and by VO2max: r=-0.10 2) and positively with body mass index (r=0.10 0). However, daily time spent with moderate and vigorous PA showed a weak positive association with tHcy in females (p<0.0 5). tHcy concentrations showed a tendency to decrease with increasing CVF and increase with increasing BMI in female European adolescents. However, tHcy concentrations were positively associated with moderate and vigorous PA in female European adolescents. © 2015, Center for Academic Publications Japan. All rights reserved.
    No preview · Article · Jan 2015 · Journal of Nutritional Science and Vitaminology
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    ABSTRACT: Objective: To measure the carotid intima-media-thickness (cIMT) and to assess its determinant factors in healthy adolescents. Methods: 319 adolescents aged 12.5-17.5 years (135 boys, 184 girls) were enrolled in this cross-sectional study. cIMT and carotid diameter were measured by high-resolution B-mode ultrasound. Anthropometric parameters, blood pressure, physical activity (PA), aerobic fitness and dietary intakes were assessed. Socioeconomic status was determined with the family affluence scale (FAS 4). Serum biological markers (lipids, glucose, high-sensitivity C-reactive protein, soluble adhesion molecules) were measured in a subsample of 96 adolescents. Results: Multiple regression analysis showed that cIMT was positively associated with truncal fat (p = 0.021) and negatively with FAS 4 (p = 0.002) independently of age and blood pressure. There were no significant associations between cIMT and PA, fitness and dietary intakes. In the subsample soluble intercellular adhesion molecule 1 was positively correlated with cIMT (p = 0.017), independently of truncal fat, age and blood pressure. Conclusions: Low socioeconomic conditions and increased truncal fat are associated with greater carotid intima-media-thickness in adolescents.
    No preview · Article · Mar 2013 · Atherosclerosis
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    ABSTRACT: To identify motivational factors linked to child health status that affected the likelihood of parents' allowing their child to participate in pediatric research. Parents were invited to return their completed questionnaires anonymously to assess motivational factors and factors that might improve participation in pediatric research. Of 573 eligible parents, 261 returned the completed questionnaires. Of these, 126 were parents of healthy children (group 1), whereas 135 were parents of sick children who were divided into two groups according to the severity of their pathology, i.e., 99 ambulatory children (group 2) and 36 nonambulatory children (group 3). The main factor motivating participation in a pediatric clinical research study was "direct benefits for their child" (87.7%, 100%, and 100% for groups 1, 2, and 3, respectively). The other factors differed significantly between the three groups, depending on the child's health status (all p < 0.05). Factors that might have a positive impact on parental consent to the participation of their child in a pediatric clinical research study differed significantly (χ2 test, all p ≤ 0.04), depending on the child's health status. The main factor was "a better understanding of the study and its regulation" for the healthy children and ambulatory sick children groups (31.2% and 82.1%, respectively), whereas this was the third factor for the nonambulatory sick children group (50%). Innovative strategies should be developed based on a child's health status to improve information provision when seeking a child's participation in pediatric research. Parents would like to spend more time in discussions with investigators.
    Full-text · Article · Feb 2013 · BMC Medical Ethics
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    ABSTRACT: BACKGROUND #ENTITYSTARTX00026; Recent studies reported a role for more than 70 genes or loci in the susceptibility to Crohn's disease (CD). However, the impact of these associations in clinical practice remains to be defined. The aim of the study was to analyse the relationship between genotypes and phenotypes for the main 53 CD-associated polymorphisms. A cohort of 798 CD patients with a median follow up of 7 years was recruited by tertiary adult and paediatric gastroenterological centres. A detailed phenotypic description of the disease was recorded, including clinical presentation, response to treatments and complications. The participants were genotyped for 53 CD-associated variants previously reported in the literature and correlations with clinical sub-phenotypes were searched for. A replication cohort consisting of 722 CD patients was used to further explore the putative associations. The NOD2 rare variants were associated with an earlier age at diagnosis (p = 0.0001) and an ileal involvement (OR = 2.25[1.49-3.41] and 2.77 [1.71-4.50] for rs2066844 and rs2066847, respectively). Colonic lesions were positively associated with the risk alleles of IL23R rs11209026 (OR = 2.25 [1.13-4.51]) and 6q21 rs7746082 (OR = 1.60 [1.10-2.34] and negatively associated with the risk alleles of IRGM rs13361189 (OR = 0.29 [0.11-0.74]) and DEFB1 rs11362 (OR = 0.50 [0.30-0.80]). The ATG16L1 and IRGM variants were associated with a non-inflammatory behaviour (OR = 1.75 [1.22-2.53] and OR = 1.50 [1.04-2.16] respectively). However, these associations lost significance after multiple testing corrections. The protective effect of the IRGM risk allele on colonic lesions was the only association replicated in the second cohort (p = 0.03). It is not recommended to genotype the studied polymorphisms in routine practice.
    Full-text · Article · Dec 2012 · PLoS ONE
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    ABSTRACT: Treatment of urinary schistosomiasis by chemotherapy remains challenging due to rapid re-infection and possibly to limited susceptibility to praziquantel treatment. Therefore, therapeutic vaccines represent an attractive alternative control strategy. The objectives of this study were to assess the safety and tolerability profile of the recombinant 28 kDa glutathione S-transferase of Schistosoma haematobium (rSh28GST) in healthy volunteers, and to determine its immunogenicity. Volunteers randomly received 100 µg rSh28GST together with aluminium hydroxide (Alum) as adjuvant (n = 8), or Alum alone as a comparator (n = 8), twice with a 28-day interval between doses. A third dose of rSh28GST or Alum alone was administered to this group at day 150. In view of the results obtained, another group of healthy volunteers (n = 8) received two doses of 300 µg of rSh28GST, again with a 28-day interval. A six-month follow-up was performed with both clinical and biological evaluations. Immunogenicity of the vaccine candidate was evaluated in terms of specific antibody production, the capacity of sera to inhibit enzymatic activity of the antigen, and in vitro cytokine production. Among the 24 healthy male participants no serious adverse events were reported in the days or weeks after administration. Four subjects under rSh28GST reported mild reactions at the injection site while a clinically insignificant increase in bilirubin was observed in 8/24 subjects. No hematological nor biochemical evidence of toxicity was detected. Immunological analysis showed that rSh28GST was immunogenic. The induced Th2-type response was characterized by antibodies capable of inhibiting the enzymatic activity of rSh28GST. rSh28GST in Alum did not induce any significant toxicity in healthy adults and generated a Th2-type immune response. Together with previous preclinical results, the data of safety, tolerability and quality of the specific immune response provide evidence that clinical trials with rSh28GST could be continued in humans as a potential vaccine candidate against urinary schistosomiasis.
    Full-text · Article · Jul 2012 · PLoS Neglected Tropical Diseases
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    ABSTRACT: In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries. Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised. The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.
    Full-text · Article · Mar 2012 · Trials
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    ABSTRACT: Road Traffic Accidents (RTA) are most probably the leading cause of post traumatic stress disorder (PTSD) in developed countries. The autonomic nervous system (ANS) disturbances, due to psychological trauma, are part of the pathophysiology of PTSD. The aim of the present study was to determine whether early heart rate variability (HRV) measurement, a biomarker of the ANS function, could act as a predictor of PTSD development after a RTA. We prospectively investigated 35 survivors of RTA with both physical injury and psychological trauma. HRV data were obtained from 24-h Holter ECG monitoring, which was performed on the second day after the accident. Time domain analysis was applied to the inter-beat (RR) interval time series to calculate the various parameters of HRV. PTSD status was assessed 2 and 6 months after RTA. There was a global diminution of HRV measurements in the PTSD group at both 2 and 6 months. The variability index was the best predictor of PTSD with the area under the receiveroperating curve for discriminating PTSD at 6 months at 0.92 (95% CI: 0.785; 1.046). A cut-off at 2.19% yielded a sensitivity of 85.7% and a specificity of 81.8% for PTSD. Positive and negative predictive values were respectively 75% and 90%. However, initial heart rate (HR) data were relevant at 2 months but not at 6 months. RTA survivors exhibiting lower parasympathetic modulation of HR, indexed by temporal analysis of HRV, are more susceptible to developing PTSD as a short and long-term outcome.
    Full-text · Article · Mar 2012 · Journal of Psychiatric Research

  • No preview · Article · Mar 2012 · Journal des Maladies Vasculaires
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    ABSTRACT: In the present subanalysis of a cross-sectional study showing the favorable effect of prior transient ischemia, leisure-time physical activity, and lipid-lowering drug therapy on stroke severity, we aimed to evaluate whether previous physical activity was dose dependently associated to minor stroke (NIHSS 0-3) and to identify possible underlying factors. Among 362 consecutive patients, less severe stroke was related to weekly exercise duration prior to stroke (no exercise: 36.1%; <2 hours: 49.3%; 2-5 hours: 58.8%; >5 hours: 64.0%; P = 0.003). Only weak and moderate exercise practices were protective (weak: 50.0%; moderate: 79.3%; heavy: 22.2%; P < 0.0001). Such a beneficial effect was observed independently of age and was associated with a trend to a lower frequency of arterial hypertension, alcohol abuse, and a better metabolic profile. Besides other therapeutic approaches, physical activity may be a simple way to decrease cerebral ischemia severity.
    Full-text · Article · Jan 2012 · Stroke Research and Treatment
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    ABSTRACT: Suicide attempts (SA) constitute a serious clinical problem. People who attempt suicide are at high risk of further repetition. However, no interventions have been shown to be effective in reducing repetition in this group of patients. Multicentre randomized controlled trial. We examine the effectiveness of "ALGOS algorithm": an intervention based in a decisional tree of contact type which aims at reducing the incidence of repeated suicide attempt during 6 months. This algorithm of case management comprises the two strategies of intervention that showed a significant reduction in the number of SA repeaters: systematic telephone contact (ineffective in first-attempters) and "Crisis card" (effective only in first-attempters). Participants who are lost from contact and those refusing healthcare, can then benefit from "short letters" or "postcards". ALGOS algorithm is easily reproducible and inexpensive intervention that will supply the guidelines for assessment and management of a population sometimes in difficulties with healthcare compliance. Furthermore, it will target some of these subgroups of patients by providing specific interventions for optimizing the benefits of case management strategy.
    Full-text · Article · Jan 2011 · BMC Psychiatry
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    ABSTRACT: Cited By (since 1996):2, Export Date: 18 October 2014
    No preview · Article · Jan 2011
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    ABSTRACT: Cited By (since 1996):2, Export Date: 18 October 2014
    No preview · Article · Jan 2011
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    ABSTRACT: 'Compassionate use' programmes allow medicinal products that are not authorised, but are in the development process, to be made available to patients with a severe disease who have no other satisfactory treatment available to them. We sought to understand how such programmes are regulated in ten European Union countries. The European Clinical Research Infrastructures Network (ECRIN) conducted a comprehensive survey on clinical research regulatory requirements, including questions on regulations of 'compassionate use' programmes. Ten European countries, covering approximately 70% of the EU population, were included in the survey (Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and the UK). European Regulation 726/2004/EC is clear on the intentions of 'compassionate use' programmes and aimed to harmonise them in the European Union. The survey reveals that different countries have adopted different requirements and that 'compassionate use' is not interpreted in the same way across Europe. Four of the ten countries surveyed have no formal regulatory system for the programmes. We discuss the need for 'compassionate use' programmes and their regulation where protection of patients is paramount. 'Compassionate use' is a misleading term and should be replaced with 'expanded access'. There is a need for expanded access programmes in order to serve the interests of seriously ill patients who have no other treatment options. To protect these patients, European legislation needs to be more explicit and informative with regard to the regulatory requirements, restrictions, and responsibilities in expanded access programmes.
    Full-text · Article · Nov 2010 · Trials
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    ABSTRACT: Increased carotid intima-media thickness (cIMT) in adults may be caused by a childhood exposure to cardiovascular risk factors. We systematically reviewed observational studies to determine whether obesity, insulin-dependent diabetes mellitus (IDDM), dyslipidemia (DL), hypertension (HT), and chronic renal failure (CRF) are associated with increased cIMT in children and adolescent patients compared with control subjects. We performed a PubMed literature search from January 1986 to February 2010. Two reviewers separately verified the inclusion criteria of relevant studies for the objective of the review. The data extracted in the patient and control groups were sample size, age, gender, cIMT measurement methods, cIMT values, and statistical analysis results. From 348 citations, 65 cross-sectional studies (2 cited twice) with case-control design met the inclusion criteria: 26 in obesity, 14 in IDDM, 11 in DL, 8 in HT, and 8 in CRF. cIMT measurement protocols varied according to the studies, with measurements being performed on the common carotid artery in 65/67 cases and on the far wall in 57/67 cases. From the 67 studies cited, 22/26 reported a significantly increased cIMT in obese children and adolescents compared with the control group, 8/14 in IDDM patients, 10/11 in DL patients, 7/8 in HT patients, and 8/8 in CRF patients. Conclusion: Despite the heterogeneity of ultrasound measurement methods, cIMT was significantly increased in 55 out of the 67 cited studies, confirming early vascular damages in pediatric populations with an increased future risk for vascular diseases.
    No preview · Article · Oct 2010 · European Journal of Pediatrics
  • C. Lamotte · C. Iliescu · C. Libersa · F. Gottrand

    No preview · Article · Sep 2010 · Journal des Maladies Vasculaires
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    Full-text · Article · Jan 2010
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    ABSTRACT: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.
    Full-text · Article · Oct 2009 · Trials
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    ABSTRACT: Anti-Saccharomyces cerevisiae antibodies (ASCAs) are present in 50-60% of patients with Crohn's disease (CD) and in 20-25% of their healthy relatives (HRs). The yeast, Candida albicans, has been shown to generate ASCAs, but the presence of C. albicans in the digestive tract of CD patients and their HRs has never been investigated. Therefore, we studied C. albicans carriage in familial CD and its correlation with ASCAs. Study groups consisted of 41 CD families composed of 129 patients and 113 HRs, and 14 control families composed of 76 individuals. Mouth swabs and stool specimens were collected for isolation, identification, and quantification of yeasts. Serum samples were collected for detection of ASCAs and anti-C. albicans mannan antibodies (ACMAs). C. albicans was isolated significantly more frequently from stool samples from CD patients (44%) and their HRs (38%) than from controls (22%) (P<0.05). The prevalence of ACMAs was similar between CD patients, their HRs, and controls (22, 19, and 21%, respectively, P=0.845), whereas the prevalence of ASCAs was significantly increased in CD families (72 and 34% in CD and HRs, respectively, in contrast to 4% in controls, P<0.0001). AMCA levels correlated with C. albicans colonization in all populations. ASCA levels correlated with C. albicans colonization in HRs but not in CD patients. CD patients and their first-degree HRs are more frequently and more heavily colonized by C. albicans than are controls. ASCAs correlate with C. albicans colonization in HRs but not in CD. In HRs, ASCAs could result from an altered immune response to C. albicans. In CD, a subsequent alteration in sensing C. albicans colonization could occur with disease onset.
    Full-text · Article · Jun 2009 · The American Journal of Gastroenterology
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    ABSTRACT: Some host-related factors may predict the risk of metastasis after surgery of colorectal cancer (CRC). The endothelial adhesion molecule E-selectin is implicated in the metastatic spread of CRC. We postulated that some polymorphisms within the E-selectin gene, especially the S128R polymorphism, may increase the risk of metastases by facilitating adhesion of tumour cells to the endothelium. We collected blood samples for DNA extraction from 264 patients treated for stage II or III CRC and from 310 healthy controls in order to assess three polymorphisms within the E-selectin gene (S128R, G98T and L554F) and one within the P-selectin gene (V640L). Genotypes were analysed by the allelic discrimination TaqMan real-time PCR assay. The S128R polymorphism was detected in 59 patients (22.3%) and was strictly correlated with the G98T polymorphism. In multivariate analysis, the S128R polymorphism was associated with shorter event-free survival (EFS) and overall survival (OS) in the whole population (EFS: P=.003, HR 1.82, 95% CI 1.23-2.70; OS: P<10(-4), HR 4.31, 95% CI 2.46-10.99), in patients with stage II CRC(EFS: P=.04, HR 1.92, 95% CI 1.02-3.60; OS: P=.02, HR 4.44, 95% CI 1.16-17.03), and in patients with stage III CRC (EFS: P=.04, HR 1.68, 95% CI 1.01-2.80; OS: P=.001, HR 4.04, 95% CI 1.73-9.46). L554F and V640L polymorphisms had no prognostic value. The S128R polymorphism is a constitutional factor associated with a higher risk of relapse and death in patients treated for CRC. This polymorphism detection may permit better selection of patients suitable for adjuvant therapy, especially among those with stage II disease.
    No preview · Article · Apr 2009 · European journal of cancer (Oxford, England: 1990)
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    ABSTRACT: Research involving humans is regulated by regulatory authorities through their specific requirements and controls. The Healthy Life Style in Europe by Nutrition in Adolescence Cross-Sectional Study (HELENA-CSS) is a multicenter biomedical research study of adolescents in several representative European cities, which requires satisfying medico-regulatory requirements including Independent Ethics Committee (IEC) approval and agreement by the national or local regulatory authorities. To achieve a high level of quality assurance relating to ethical issues, we followed the good clinical practices (GCP) described at the International Conference on Harmonisation (ICH), which we adapted to the national and local situations of each of the 11 participating cities in 10 European countries. The main objective of the HELENA-CSS is to evaluate reliable and comparable data of nutritional habits and lifestyle in a representative sample of European adolescents. The aim of this paper is to present the methods relating to the ethical and regulatory issues of this study and to describe the current state of the medico-regulatory requirements involved in conducting this kind of study in each country. Following the GCP-ICH guidelines, a protocol describing the HELENA-CSS was written and approved by all partners. In the pilot study, a case report form adapted to the study objectives and its manual of operation was constructed and used by all partners. All information letters to adolescents and their parents and consent forms were first written in English, then translated into the local language, and adapted to each local situation. All documents were then checked centrally for any deviation and corrected if required. An operation manual relating to ethical issues and other medico-regulatory requirements was also developed. This paper presents the current status of the medico-regulatory requirements from each HELENA-CSS participant country.Results:Before the beginning of the study, most centers had satisfied the medico-regulatory requirements of IEC approval and agreement with other national or local regulatory authorities/organizations. For a few centers, some problems were detected and corrective actions were taken to improve missing information to reach a high level of quality assurance of ethical issues. The GCP-ICH guidelines about nontherapeutic biomedical research are interpreted and applied differently across Europe. This study shows that high-quality nontherapeutic biomedical research can address the ethical issues included in the GCP-ICH regulations and can be harmonized among the HELENA European partners.
    Full-text · Article · Dec 2008 · International journal of obesity (2005)

Publication Stats

3k Citations
362.13 Total Impact Points

Institutions

  • 1990-2013
    • University of Lille Nord de France
      Lille, Nord-Pas-de-Calais, France
  • 2008-2012
    • Unité Inserm U1077
      Caen, Lower Normandy, France
  • 1991-2012
    • Centre Hospitalier Régional Universitaire de Lille
      • Division of Neurology
      Lille, Nord-Pas-de-Calais, France
  • 1995-2006
    • Université du Droit et de la Santé Lille 2
      • Faculty of Medicine
      Lille, Nord-Pas-de-Calais, France
  • 2005
    • Centre D'Investigations Préventives Et Cliniques
      Lutetia Parisorum, Île-de-France, France
  • 2001
    • French Institute of Health and Medical Research
      Lutetia Parisorum, Île-de-France, France