IntroductionEven using well-established technology assessment processes, the basis of the decisio... more IntroductionEven using well-established technology assessment processes, the basis of the decisions on drug price and reimbursement are sometimes perceived as poorly informed and sometimes may be seen as disconnected from value. The literature remains inconclusive about how Health Technology Assessment Bodies (HTAb) should report the determinants of their decisions. This study evaluates the relationship between oncology and hematology drug list prices and structured value parameters at the time of reimbursement decision in Spain.MethodsThe study includes all new onco-hematological products (22), with a first indication authorized between January 2017 and December 2019 in Spain and pricing decisions published up until October 2022. For each product, 56 contextual and non-contextual indicators reflecting the structured multiple criteria decision analysis (MCDA) – Evidence-based Decision-Making (EVIDEM) framework were measured. The relationship between prices and the MCDA-EVIDEM framew...
Background: Home mechanical ventilation is usually initiated in hospital. However, costeffectiven... more Background: Home mechanical ventilation is usually initiated in hospital. However, costeffectiveness of inpatient set up has never been compared to outpatient adaptation in a randomized design. A Prospective, multicenter, non-inferiority trial was conducted comparing the effectiveness of adaptation to noninvasive mechanical ventilation (NIMV) performed in the ambulatory or hospital setting in patients with chronic respiratory failure secondary to restrictive thoracic disease, obesity-hypoventilation syndrome or neuromuscular disease. Methods: The study included 53 candidates for NIMV, randomized to ambulatory adaptation (AA) (n Z 27) or hospital adaptation (HA) (n Z 26). The patients' characteristics were recorded before establishing ventilation and at 1 and 6 months after. The main outcome variable was PaCO 2 decrease at 6 months following initiation of NIMV. The direct costs of the two interventions were compared. Results: Before starting NIMV, PaCO 2 was 50.4 AE 6.8 mmHg in the AA group and 50.3 AE 5.7 mmHg in the HA group. At 6 months of NIMV use, a significant improvement in PaCO 2
Background ARDS can produce a loss of lung function with persistent sequelae. This study aimed to... more Background ARDS can produce a loss of lung function with persistent sequelae. This study aimed to evaluate healthrelated quality of life (HRQL) in survivors of ARDS compared with a healthy reference population and to determine the middle/long-term radiographic abnormalities and functional status, as well as their relation to observed HRQL, in these patients. Methods This was a prospective study carried out in three ICUs. HRQL in patients was determined with the Nottingham Health Profile immediately after ARDS diagnosis and 6 months after diagnosis. Patients underwent complete respiratory function testing, chest CT scan study, and the 6-min walk test. Results Follow-up was conducted in 38 patients with ARDS. Survivors of ARDS presented a poorer overall HRQL vs the general population, mainly because of lower scores in the dimensions related to mobility, energy, and social isolation. Limitations in daily life activities were documented in 40%. Respiratory function was altered in 67%, with a restrictive respiratory pattern in 58%. Radiologic study disclosed alterations in 76% (mainly reticular pattern). Patients were able to cover only 366 m (318-411 m) in the 6-min walk test and had a minimum pulse oximetry of 93% (90%-94%). A significant correlation was documented between the overall quality of life at first and at 6 months (r = 0.68, P < .01). Conclusions Survivors of ARDS after 6 months had a poorer HRQL than the healthy population and showed mild radiographic and functional involvement. Early HRQL study in these patients enabled early detection of those who would present more long-term HRQL morbidity.
medRxiv (Cold Spring Harbor Laboratory), Aug 4, 2020
doi: medRxiv preprint NOTE: This preprint reports new research that has not been certified by pee... more doi: medRxiv preprint NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
Background: Premature birth is considered one of the main problems in modern Obstetrics. It cause... more Background: Premature birth is considered one of the main problems in modern Obstetrics. It causes more than 50 % of neonatal mortality; it is responsible for a large proportion of infant morbidity and incurs very high economic costs. Cervical length, which can be accurately measured by ultrasound, has an inverse relationship with the risk of preterm birth. As a result, having an effective intervention for asymptomatic patients with short cervix could reduce the prematurity. Although recently published data demonstrates the effectiveness of vaginal progesterone and cervical pessary, these treatments have never been compared to one another. Methods/Design: The PESAPRO study is a noncommercial, multicenter, open-label, randomized clinical trial (RCT) in pregnant women with a short cervix as identified by transvaginal ultrasonography at 19 to 22 weeks of gestation. Patients are randomized (1:1) to either daily vaginal progesterone or cervical pessary until the 37th week of gestation or delivery; whichever comes first. During the trial, women visit every 4 weeks for routine questions and tests. The primary outcome is the proportion of spontaneous preterm deliveries before 34 weeks of gestation. A sample size of 254 pregnant women will be included at 29 participating hospitals in order to demonstrate noninferiority of placing a pessary versus vaginal progesterone. The first patient was randomized in August 2012, and recruitment of study subjects will continue until the end of December 2015. Discussion: This trial assesses the comparative efficacy and safety between two accepted treatments, cervical pessary versus vaginal progesterone, and it will provide evidence in order to establish clinical recommendations.
Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees o... more Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees of safety and efficacy are not always granted in clinical practice compared to adult authorised indications. A retrospective observational study was done to estimate the prevalence of psychotropic use in pediatric subjects of Catalonia (Spain). Anonymised data on dispensation of psychotropics to pediatric patients, demography and other related data were obtained by the local healthcare management for the period 2008–2017. Estimation of off-label use was done through description of drug dispensations with no authorised use related to age range. The prevalence of psychotropics was 40.8–64.2 per 1,000 pediatric inhabitants. Hydroxyzine-only represented two-thirds of dispensations, and when removed, the prevalence dropped to 26.4–32.2 per 1,000 pediatric inhabitants. Adolescents and boys were more likely to receive a psychotropic. Psychostimulants had the highest exposure rate, mainly due to ...
BACKGROUND. Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVI... more BACKGROUND. Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19. Evidence from controlled clinical trials is inconclusive. METHODS. We conducted a randomized, open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high-flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (noninvasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7 (death) at 14 days. Primary analysis was performed in the intention-to-treat population. RESULTS. Between April 4, 2020, and February 5, 2021, 350 patients were randomly assigned to either CP (n = 179) or SOC (n = 171). At 14 days, proportion of patients in categories 5, 6, or 7 was 11.7% in the CP group versus 16.4% in the control group (P = 0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in the CP group versus 17.0% in the control group (P = 0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95% CI 0.19-1.14, log-rank P = 0.087). CONCLUSION. CP showed a significant benefit in preventing progression to noninvasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO, or death at 28 days. The effect on the predefined primary endpoint at 14 days and the effect on overall survival were not statistically significant. TRIAL REGISTRATION. Clinicaltrials.gov, NCT04345523.
Sustained virological response (SVR) to direct‐acting antivirals ameliorates portal hypertension,... more Sustained virological response (SVR) to direct‐acting antivirals ameliorates portal hypertension, improves hepatic function and may reverse the procoagulant state observed in patients with cirrhosis. However, an unexpected incidence of portal vein thrombosis (PVT) immediately after antiviral therapy has recently been reported. Therefore, we analysed the long‐term impact of SVR on the development of non‐tumoural PVT.
Delta ligands regulate Notch signaling in normal intestinal stem cells, while Jagged1 activates N... more Delta ligands regulate Notch signaling in normal intestinal stem cells, while Jagged1 activates Notch in intestinal adenomas carrying active β-catenin. We used the Apc Min/+ mouse model, tumor spheroid cultures, and patient-derived orthoxenografts to address this divergent ligand-dependent Notch function and its implication in disease. We found that intestinalspecific Jag1 deletion or antibody targeting Jag1 prevents tumor initiation in mice. Addiction to Jag1 is concomitant with the absence of Manic Fringe (MFNG) in adenoma cells, and its ectopic expression reverts Jag1 dependence. In 239 human colorectal cancer patient samples, MFNG imposes a negative correlation between Jag1 and Notch, being high Jag1 in the absence of MFNG predictive of poor prognosis. Jag1 antibody treatment reduces patient-derived tumor orthoxenograft growth without affecting normal intestinal mucosa. Our data provide an explanation to Jag1 dependence in cancer, and reveal that Jag1-Notch1 interference provides therapeutic benefit in a subset of colorectal cancer and FAP syndrome patients.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Randomized clinical trials are the gold standard when experimental designs are feasible. Randomiz... more Randomized clinical trials are the gold standard when experimental designs are feasible. Randomization allows the handling of allocation bias for known and unknown confounders. Specific tools such as blocking, stratification, and dynamic allocation provide additional guarantees to simple randomization. When an experimental design is not feasible, the propensity score (PS) has been shown to produce greater benefit than traditional methods (i.e., restriction, stratification, matching and adjusting). There appears to be a hierarchy in terms of the effectiveness of balancing for PS techniques: matching or weighting above stratification above covariate adjustment (which is discouraged due to its drawbacks). Instrumental variable analysis and its variants might provide added value because they aim to balance for unknown confounders as well, thus mimicking randomization, but at present, are considered more useful for sensitivity rather than primary analyses.
Junior: study concept and design, acquisition of data, analysis and interpretation of data, stati... more Junior: study concept and design, acquisition of data, analysis and interpretation of data, statistical analysis, drafting of the manuscript. Fanny Turon: study concept and design, acquisition of data, drafting of the manuscript. Anna Baiges: acquisition of data and drafting of the manuscript. Eira Cerda: acquisition of data. Ángeles Garcia-Criado: drafting of the manuscript.
Antimicrobial Agents and Chemotherapy, Nov 1, 2006
We assessed the in vitro toxicity of tenofovir (TFV) and compared it with those of zidovudine (AZ... more We assessed the in vitro toxicity of tenofovir (TFV) and compared it with those of zidovudine (AZT), didanosine (ddI), ritonavir (RTV), and lopinavir (LPV) alone and in combination in human renal proximal tubule epithelial cells (RPTECs). The cells were treated with various concentrations and combinations of the tested antiretrovirals for up to 22 days, and cytotoxicity was determined. In addition, we assessed the levels of mitochondrial DNA (mtDNA) and cytochrome oxidase II (COII) mRNA in RPTECs treated with reverse transcriptase inhibitors. TFV alone was not associated with significant cytotoxicity. ddI showed pronounced cytotoxicity that was greater than those of AZT (P ؍ 0.002) and TFV (P ؍ 0.0001). The combination of 10 M RTV and 40 M LPV significantly reduced RPTEC viability (P < 0.0001), and TFV tended to partially reduce this effect. TFV alone affected neither mtDNA nor COII mRNA levels, whereas ddI caused a profound depletion of mtDNA and a parallel reduction in COII mRNA expression. The effects of ddI, but not those of AZT, on mtDNA and COII mRNA were further enhanced in the presence of TFV, a finding consistent with the inhibition of ddI clearance by TFV. The addition of TFV to ddI or AZT appeared to slightly increase the COII mRNA/mtDNA ratio relative to that in cells treated with ddI or AZT alone. Together, these in vitro results indicate that combination with other antiretrovirals does not significantly increase the toxic potential of TFV in RPTECs.
Effects of docosahexanoic acid supplementation on inflammatory and subcutaneous adipose tissue ge... more Effects of docosahexanoic acid supplementation on inflammatory and subcutaneous adipose tissue gene expression in HIV-infected patients on combination antiretroviral therapy (cART). A sub-study of a randomized, double-blind, placebo-controlled study
IntroductionEven using well-established technology assessment processes, the basis of the decisio... more IntroductionEven using well-established technology assessment processes, the basis of the decisions on drug price and reimbursement are sometimes perceived as poorly informed and sometimes may be seen as disconnected from value. The literature remains inconclusive about how Health Technology Assessment Bodies (HTAb) should report the determinants of their decisions. This study evaluates the relationship between oncology and hematology drug list prices and structured value parameters at the time of reimbursement decision in Spain.MethodsThe study includes all new onco-hematological products (22), with a first indication authorized between January 2017 and December 2019 in Spain and pricing decisions published up until October 2022. For each product, 56 contextual and non-contextual indicators reflecting the structured multiple criteria decision analysis (MCDA) – Evidence-based Decision-Making (EVIDEM) framework were measured. The relationship between prices and the MCDA-EVIDEM framew...
Background: Home mechanical ventilation is usually initiated in hospital. However, costeffectiven... more Background: Home mechanical ventilation is usually initiated in hospital. However, costeffectiveness of inpatient set up has never been compared to outpatient adaptation in a randomized design. A Prospective, multicenter, non-inferiority trial was conducted comparing the effectiveness of adaptation to noninvasive mechanical ventilation (NIMV) performed in the ambulatory or hospital setting in patients with chronic respiratory failure secondary to restrictive thoracic disease, obesity-hypoventilation syndrome or neuromuscular disease. Methods: The study included 53 candidates for NIMV, randomized to ambulatory adaptation (AA) (n Z 27) or hospital adaptation (HA) (n Z 26). The patients' characteristics were recorded before establishing ventilation and at 1 and 6 months after. The main outcome variable was PaCO 2 decrease at 6 months following initiation of NIMV. The direct costs of the two interventions were compared. Results: Before starting NIMV, PaCO 2 was 50.4 AE 6.8 mmHg in the AA group and 50.3 AE 5.7 mmHg in the HA group. At 6 months of NIMV use, a significant improvement in PaCO 2
Background ARDS can produce a loss of lung function with persistent sequelae. This study aimed to... more Background ARDS can produce a loss of lung function with persistent sequelae. This study aimed to evaluate healthrelated quality of life (HRQL) in survivors of ARDS compared with a healthy reference population and to determine the middle/long-term radiographic abnormalities and functional status, as well as their relation to observed HRQL, in these patients. Methods This was a prospective study carried out in three ICUs. HRQL in patients was determined with the Nottingham Health Profile immediately after ARDS diagnosis and 6 months after diagnosis. Patients underwent complete respiratory function testing, chest CT scan study, and the 6-min walk test. Results Follow-up was conducted in 38 patients with ARDS. Survivors of ARDS presented a poorer overall HRQL vs the general population, mainly because of lower scores in the dimensions related to mobility, energy, and social isolation. Limitations in daily life activities were documented in 40%. Respiratory function was altered in 67%, with a restrictive respiratory pattern in 58%. Radiologic study disclosed alterations in 76% (mainly reticular pattern). Patients were able to cover only 366 m (318-411 m) in the 6-min walk test and had a minimum pulse oximetry of 93% (90%-94%). A significant correlation was documented between the overall quality of life at first and at 6 months (r = 0.68, P < .01). Conclusions Survivors of ARDS after 6 months had a poorer HRQL than the healthy population and showed mild radiographic and functional involvement. Early HRQL study in these patients enabled early detection of those who would present more long-term HRQL morbidity.
medRxiv (Cold Spring Harbor Laboratory), Aug 4, 2020
doi: medRxiv preprint NOTE: This preprint reports new research that has not been certified by pee... more doi: medRxiv preprint NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
Background: Premature birth is considered one of the main problems in modern Obstetrics. It cause... more Background: Premature birth is considered one of the main problems in modern Obstetrics. It causes more than 50 % of neonatal mortality; it is responsible for a large proportion of infant morbidity and incurs very high economic costs. Cervical length, which can be accurately measured by ultrasound, has an inverse relationship with the risk of preterm birth. As a result, having an effective intervention for asymptomatic patients with short cervix could reduce the prematurity. Although recently published data demonstrates the effectiveness of vaginal progesterone and cervical pessary, these treatments have never been compared to one another. Methods/Design: The PESAPRO study is a noncommercial, multicenter, open-label, randomized clinical trial (RCT) in pregnant women with a short cervix as identified by transvaginal ultrasonography at 19 to 22 weeks of gestation. Patients are randomized (1:1) to either daily vaginal progesterone or cervical pessary until the 37th week of gestation or delivery; whichever comes first. During the trial, women visit every 4 weeks for routine questions and tests. The primary outcome is the proportion of spontaneous preterm deliveries before 34 weeks of gestation. A sample size of 254 pregnant women will be included at 29 participating hospitals in order to demonstrate noninferiority of placing a pessary versus vaginal progesterone. The first patient was randomized in August 2012, and recruitment of study subjects will continue until the end of December 2015. Discussion: This trial assesses the comparative efficacy and safety between two accepted treatments, cervical pessary versus vaginal progesterone, and it will provide evidence in order to establish clinical recommendations.
Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees o... more Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees of safety and efficacy are not always granted in clinical practice compared to adult authorised indications. A retrospective observational study was done to estimate the prevalence of psychotropic use in pediatric subjects of Catalonia (Spain). Anonymised data on dispensation of psychotropics to pediatric patients, demography and other related data were obtained by the local healthcare management for the period 2008–2017. Estimation of off-label use was done through description of drug dispensations with no authorised use related to age range. The prevalence of psychotropics was 40.8–64.2 per 1,000 pediatric inhabitants. Hydroxyzine-only represented two-thirds of dispensations, and when removed, the prevalence dropped to 26.4–32.2 per 1,000 pediatric inhabitants. Adolescents and boys were more likely to receive a psychotropic. Psychostimulants had the highest exposure rate, mainly due to ...
BACKGROUND. Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVI... more BACKGROUND. Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19. Evidence from controlled clinical trials is inconclusive. METHODS. We conducted a randomized, open-label, controlled clinical trial at 27 hospitals in Spain. Patients had to be admitted for COVID-19 pneumonia within 7 days from symptom onset and not on mechanical ventilation or high-flow oxygen devices. Patients were randomized 1:1 to treatment with CP in addition to standard of care (SOC) or to the control arm receiving only SOC. The primary endpoint was the proportion of patients in categories 5 (noninvasive ventilation or high-flow oxygen), 6 (invasive mechanical ventilation or extracorporeal membrane oxygenation [ECMO]), or 7 (death) at 14 days. Primary analysis was performed in the intention-to-treat population. RESULTS. Between April 4, 2020, and February 5, 2021, 350 patients were randomly assigned to either CP (n = 179) or SOC (n = 171). At 14 days, proportion of patients in categories 5, 6, or 7 was 11.7% in the CP group versus 16.4% in the control group (P = 0.205). The difference was greater at 28 days, with 8.4% of patients in categories 5-7 in the CP group versus 17.0% in the control group (P = 0.021). The difference in overall survival did not reach statistical significance (HR 0.46, 95% CI 0.19-1.14, log-rank P = 0.087). CONCLUSION. CP showed a significant benefit in preventing progression to noninvasive ventilation or high-flow oxygen, invasive mechanical ventilation or ECMO, or death at 28 days. The effect on the predefined primary endpoint at 14 days and the effect on overall survival were not statistically significant. TRIAL REGISTRATION. Clinicaltrials.gov, NCT04345523.
Sustained virological response (SVR) to direct‐acting antivirals ameliorates portal hypertension,... more Sustained virological response (SVR) to direct‐acting antivirals ameliorates portal hypertension, improves hepatic function and may reverse the procoagulant state observed in patients with cirrhosis. However, an unexpected incidence of portal vein thrombosis (PVT) immediately after antiviral therapy has recently been reported. Therefore, we analysed the long‐term impact of SVR on the development of non‐tumoural PVT.
Delta ligands regulate Notch signaling in normal intestinal stem cells, while Jagged1 activates N... more Delta ligands regulate Notch signaling in normal intestinal stem cells, while Jagged1 activates Notch in intestinal adenomas carrying active β-catenin. We used the Apc Min/+ mouse model, tumor spheroid cultures, and patient-derived orthoxenografts to address this divergent ligand-dependent Notch function and its implication in disease. We found that intestinalspecific Jag1 deletion or antibody targeting Jag1 prevents tumor initiation in mice. Addiction to Jag1 is concomitant with the absence of Manic Fringe (MFNG) in adenoma cells, and its ectopic expression reverts Jag1 dependence. In 239 human colorectal cancer patient samples, MFNG imposes a negative correlation between Jag1 and Notch, being high Jag1 in the absence of MFNG predictive of poor prognosis. Jag1 antibody treatment reduces patient-derived tumor orthoxenograft growth without affecting normal intestinal mucosa. Our data provide an explanation to Jag1 dependence in cancer, and reveal that Jag1-Notch1 interference provides therapeutic benefit in a subset of colorectal cancer and FAP syndrome patients.
This article is an open access article distributed under the terms and conditions of the Creative... more This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY
Randomized clinical trials are the gold standard when experimental designs are feasible. Randomiz... more Randomized clinical trials are the gold standard when experimental designs are feasible. Randomization allows the handling of allocation bias for known and unknown confounders. Specific tools such as blocking, stratification, and dynamic allocation provide additional guarantees to simple randomization. When an experimental design is not feasible, the propensity score (PS) has been shown to produce greater benefit than traditional methods (i.e., restriction, stratification, matching and adjusting). There appears to be a hierarchy in terms of the effectiveness of balancing for PS techniques: matching or weighting above stratification above covariate adjustment (which is discouraged due to its drawbacks). Instrumental variable analysis and its variants might provide added value because they aim to balance for unknown confounders as well, thus mimicking randomization, but at present, are considered more useful for sensitivity rather than primary analyses.
Junior: study concept and design, acquisition of data, analysis and interpretation of data, stati... more Junior: study concept and design, acquisition of data, analysis and interpretation of data, statistical analysis, drafting of the manuscript. Fanny Turon: study concept and design, acquisition of data, drafting of the manuscript. Anna Baiges: acquisition of data and drafting of the manuscript. Eira Cerda: acquisition of data. Ángeles Garcia-Criado: drafting of the manuscript.
Antimicrobial Agents and Chemotherapy, Nov 1, 2006
We assessed the in vitro toxicity of tenofovir (TFV) and compared it with those of zidovudine (AZ... more We assessed the in vitro toxicity of tenofovir (TFV) and compared it with those of zidovudine (AZT), didanosine (ddI), ritonavir (RTV), and lopinavir (LPV) alone and in combination in human renal proximal tubule epithelial cells (RPTECs). The cells were treated with various concentrations and combinations of the tested antiretrovirals for up to 22 days, and cytotoxicity was determined. In addition, we assessed the levels of mitochondrial DNA (mtDNA) and cytochrome oxidase II (COII) mRNA in RPTECs treated with reverse transcriptase inhibitors. TFV alone was not associated with significant cytotoxicity. ddI showed pronounced cytotoxicity that was greater than those of AZT (P ؍ 0.002) and TFV (P ؍ 0.0001). The combination of 10 M RTV and 40 M LPV significantly reduced RPTEC viability (P < 0.0001), and TFV tended to partially reduce this effect. TFV alone affected neither mtDNA nor COII mRNA levels, whereas ddI caused a profound depletion of mtDNA and a parallel reduction in COII mRNA expression. The effects of ddI, but not those of AZT, on mtDNA and COII mRNA were further enhanced in the presence of TFV, a finding consistent with the inhibition of ddI clearance by TFV. The addition of TFV to ddI or AZT appeared to slightly increase the COII mRNA/mtDNA ratio relative to that in cells treated with ddI or AZT alone. Together, these in vitro results indicate that combination with other antiretrovirals does not significantly increase the toxic potential of TFV in RPTECs.
Effects of docosahexanoic acid supplementation on inflammatory and subcutaneous adipose tissue ge... more Effects of docosahexanoic acid supplementation on inflammatory and subcutaneous adipose tissue gene expression in HIV-infected patients on combination antiretroviral therapy (cART). A sub-study of a randomized, double-blind, placebo-controlled study
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