title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Keywords | Open Access funding enabled and organized by CAUL and its Member Institutions | PMC10261239 | ||
Introduction | cancers, type II diabetes | CANCERS, CARDIOVASCULAR DISEASE, AIDS, DISEASE, DISEASES, TYPE II DIABETES | The health benefits of exercise for reducing the risk of non-communicable diseases such as cardiovascular disease, type II diabetes and some cancers, are well documented (Centers for Disease Control & Prevention, The number of hours in a day is fixed and finite, distributed between obligatory time (such as time spent w... | PMC10261239 |
Methods | weight loss, ’ | SECONDARY | This study was registered with the Australian New Zealand Clinical Trials Registry (Participants were recruited from the local community and metropolitan universities via electronic media and print advertising. Interested individuals were screened for eligibility by web-based or telephone survey, which included stage o... | PMC10261239 |
Discussion | ’ | How individuals restructure the timing of their behaviors can influence the effectiveness of exercise, and have important health consequences, depending on what activities are displaced (Chastin et al., According to baseline estimates, on average, participants spent approximately two hours per day watching television (... | PMC10261239 | |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 53 kb) | PMC10261239 | ||
Authors’ contribution | PB was responsible for conceptualisation and design of the study, the acquisition, analysis and interpretation of data, and manuscript writing. SG contributed to design of the study, data interpretation and critical revision of the manuscript. NM contributed to the acquisition and analysis of data, and critical revisio... | PMC10261239 | ||
Funding | Open Access funding enabled and organized by CAUL and its Member Institutions. PB was supported by an Australian Government Research Training Programme scholarship. | PMC10261239 | ||
Availability of data and material | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10261239 | ||
Code availability | Not applicable. | PMC10261239 | ||
Declarations | PMC10261239 | |||
Conflicts of interest | Not applicable. | PMC10261239 | ||
Human and animal rights and Informed consent | This study was approved by the Bellberry Human Research Ethics Committee (HREC2016-02–130). All procedures, including the informed consent process, were conducted in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration... | PMC10261239 | ||
Consent for publication | Not applicable. | PMC10261239 | ||
References | PMC10261239 | |||
Subject terms | Activated brown fat (aBAT) is known to affect the evaluation of Open Access funding enabled and organized by Projekt DEAL. | PMC10713612 | ||
Introduction | Hodgkin Lymphoma, young lymphoma | HODGKIN LYMPHOMA | Activated brown adipose tissue (aBAT) on In young lymphoma patients In the second prospective trial of the European Network for Pediatric Hodgkin Lymphoma (EuroNet-PHL-C2; EudraCT: 2012-004053-88; ClinicalTrials.gov Identifier: NCT02797717), The aim of this study was to investigate retrospectively different factors, wh... | PMC10713612 |
Methods | PMC10713612 | |||
Data sources and data acquisition | Every EuroNet-PHL-C2 trial patient received All imaging data (For the current study, 528 consecutive The scans were checked for aBAT by two experienced technologists (both > 20 years of working experience). Beforehand, both underwent an intensive training conducted by a nuclear medicine physician who served as the refe... | PMC10713612 | ||
Ethics declarations | Written informed consent was obtained from all patients and/or their legal guardians before inclusion into the EuroNet-PHL-C2 trial. The trial was performed in accordance with good clinical practice and the Declaration of Helsinki. The Ethics Committee of the Medical Faculty of the University of Leipzig which is regist... | PMC10713612 | ||
Statistics | This is a retrospectively performed observational study. The preventive measures analyzed were not randomized or prescribed, but followed mainly site-specific policies. Therefore, our strategy of analyses was to first look at single factors (gender, age, BMI_sds, outside temperature, predisposition to aBAT) which may h... | PMC10713612 | ||
Results | PMC10713612 | |||
General results | aBAT was detected on 94 of the 528 Overview of performed or not performed measures to prevent aBAT.General policy (*) means that young patients who undergo | PMC10713612 | ||
Univariate analysis of factors with possible influence on aBAT | PMC10713612 | |||
Gender | Table Frequency of aBAT in relation to gender. | PMC10713612 | ||
Age | Patients included in our analysis were between 2 and 18 years old. They were divided into two groups setting a cut-off at 11 years. The intention of this cut-off was to distinguish pre-pubertal from pubertal or post-pubertal patients.The numbers in Table Frequency of aBAT in relation to age. | PMC10713612 | ||
BMI_sds | BMI_sds was only calculable for the patients of 506 of the 528 Influence of BMI_sds on the frequency of aBAT (blue curve). Green circles = no aBAT, red circles = aBAT. Dashed line = basis rate of aBAT. | PMC10713612 | ||
Outside temperature | Figure Influence of the average outdoor temperature on the frequency of aBAT (blue curve). Green circles = no aBAT, red circles = aBAT. Dashed line = basis rate of aBAT. | PMC10713612 | ||
Influence of outside temperature on preventive measures | We first explored whether the outside temperature had an influence on the choice of the preventive measure: Fig. Interrelation between the outside temperature and the execution of preventive measures: (As a next step, we conducted the same analysis for propranolol: Fig. | PMC10713612 | ||
Patient predisposition | We looked at pairs of | PMC10713612 | ||
Model analysis on the effect of preventive measures | REGRESSION | To synthesize our findings, we fitted a logistic regression model (with patient as random effect to account for multiple images per patient) with all factors found to be relevant in the preceding analyses. From the model, we calculate the predicted probability of aBAT as a function of average outside temperature (in °C... | PMC10713612 | |
Discussion | PEDIATRIC CANCER | aBAT on Our results show that aBAT frequency did not differ between male and female patients, which is in line with several previously performed studies (one with 385 scans, the other with 2792 scans in pediatric cancer patients)With regard to age, we observed that pediatric patients under the age of 11 had less aBAT c... | PMC10713612 | |
Conclusion | Warming is a simple, cheap and non-invasive method to reduce the risk of aBAT. However, the effect of warming decreases with increasing outdoor temperatures and might be completely neutralized, e.g. as soon as air conditioning systems are in operation during the tracer uptake phase. The administration of propranolol ap... | PMC10713612 | ||
Acknowledgements | PD, der Technischen Universität, Christoph Rischpler | NEUMANN, FRANK, DER | We acknowledge the efforts made by all nuclear medicine physicians and technologists to provide necessary information and image data: Prof. Dr. Peter Bartenstein, Department of Nuclear Medicine, LMU Munich; Prof. Dr. Frank M. Bengel, Department of Nuclear Medicine, Medizinische Hochschule Hannover; Prof. Dr. Ambros J. ... | PMC10713612 |
Author contributions | L.K. | L.K., C.P., D.H., D.S., and R.K. analyzed the data and wrote the manuscript. C.M.K., D.K., and M.C. provided patient data. C.P. and S.N. analyzed the | PMC10713612 | |
Funding | Open Access funding enabled and organized by Projekt DEAL. | PMC10713612 | ||
Data availability | The data (tables) that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10713612 | ||
Competing interests | The authors declare no competing interests. | PMC10713612 | ||
References | PMC10713612 | |||
Background | The phase III MONALEESA-3 trial included first- (1L) and second-line (2L) patients and demonstrated a significant overall survival (OS) benefit for ribociclib + fulvestrant in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer (ABC) in the final... | PMC10469877 | ||
Methods | CFS | DISEASE | Postmenopausal patients with HR+/HER2− ABC were randomized 2:1 to 1L/2L fulvestrant + ribociclib or placebo. OS in 1L patients (de novo disease or relapse > 12 months from completion of [neo]adjuvant ET) was assessed by Cox proportional hazards model and Kaplan–Meier methods. Progression-free survival 2 (PFS2) and chem... | PMC10469877 |
Results | CFS | At data cutoff (January 12, 2022; median follow-up time, 70.8 months), mOS was 67.6 versus 51.8 months with 1L ribociclib versus placebo (hazard ratio (HR) 0.67; 95% CI 0.50–0.90); 16.5% and 8.6% of ribociclib and placebo patients, respectively, were still receiving treatment. PFS2 (HR 0.64) and CFS (HR 0.62) favored r... | PMC10469877 | |
Conclusions | This analysis of MONALEESA-3 reports the longest mOS thus far (67.6 months) for 1L patients in a phase III ABC trial. These results in a 1L population show that the OS benefit of ribociclib was maintained through extended follow-up, further supporting its use in HR+/HER2− ABC. | PMC10469877 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13058-023-01701-9. | PMC10469877 | ||
Keywords | PMC10469877 | |||
Introduction | The addition of CDK4/6 inhibitors (CDK4/6is) to endocrine therapy (ET) has greatly improved outcomes for patients with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC) [First-line palbociclib in combination with the nonsteroidal aromatase inhibitor (... | PMC10469877 | ||
Methods | PMC10469877 | |||
Study design | Details of the MONALEESA-3 trial have been described previously [ | PMC10469877 | ||
Participants | Tumors, advanced/metastatic disease | ONCOLOGY, DISEASE, LYTIC BONE LESION, TUMORS | Men and postmenopausal women aged ≥ 18 years, with histologically or cytologically confirmed HR+/HER2− ABC (locoregionally recurrent or metastatic and not amenable to curative therapy) were eligible for the study. An Eastern Cooperative Oncology Group performance status of 0 or 1 and measurable disease according to Res... | PMC10469877 |
Endpoints | ADVERSE EVENT, SECONDARY, ADVERSE EVENT | The final prespecified analyses of the primary endpoint of investigator-assessed PFS and the secondary endpoint of OS, as well as the extended follow-up (median, 56.3 months) analysis of MONALEESA-3, have been reported previously [Survival follow-up continued for patients who discontinued study treatment. Adverse event... | PMC10469877 | |
Statistical analysis | CFS | EVENTS | In this exploratory analysis of OS, mOS and OS rates were estimated using the Kaplan–Meier method. The HR for OS was estimated using a Cox proportional hazards model. Patients without events were censored at the date they were last known to be alive. Analyses were performed on the data in the overall trial population, ... | PMC10469877 |
Results | PMC10469877 | |||
Patient disposition | death | DISEASE PROGRESSION | Overall, 726 postmenopausal women were randomly assigned between June 18, 2015, and June 10, 2016: 484 to the ribociclib arm and 242 to the placebo arm. The baseline characteristics of the patients were included in the previously published analyses [In the first-line (de novo or late relapse) subgroup, 237 patients wer... | PMC10469877 |
PFS2 in patients in first-line subgroup | DISEASE PROGRESSION, PROGRESSION | Following study treatment in the first-line setting, 130 of 237 patients (54.9%) in the ribociclib arm and 93 of 128 patients (72.7%) in the placebo arm had disease progression while receiving subsequent therapy. The median PFS2 was 16.1 months longer in the ribociclib arm (50.7 months; 95% CI 42.1–58.9 months) versus ... | PMC10469877 | |
Safety | With this extended follow-up analysis at 70.8 months, no new safety signals were observed. Overall, AEs for the overall trial population were consistent with those previously reported in the prior analyses of MONALESSA-3 [ | PMC10469877 | ||
Discussion | death, CFS, breast cancer | BREAST CANCER | This exploratory analysis of MONALEESA-3, with a median follow-up of 70.8 months, reports the longest mOS benefit to date (67.6 months in the ribociclib + fulvestrant arm) for a first-line population (de novo or late relapse) in a phase III clinical trial setting in ABC. First-line ribociclib + fulvestrant demonstrated... | PMC10469877 |
Conclusions | In MONALEESA-3, with a follow-up of nearly 6 years, ribociclib + fulvestrant demonstrated the longest mOS observed to date for a first-line population in a phase III clinical trial. This is the third phase III study of ribociclib demonstrating a significant OS advantage in first-line treatment of patients with HR+/HER2... | PMC10469877 | ||
Acknowledgements | The study was sponsored by Novartis. We thank the patients who participated in this trial, their families, and their caregivers; members of the data monitoring committee; members of the study steering committee; staff members who helped with the trial at each site; and Shashank Tandon, PhD, of MediTech Media for medica... | PMC10469877 | ||
Author contributions | All authors have reviewed and approved the data, contributed to the development and approval of the manuscript, and acknowledged the decision to submit the manuscript for publication. | PMC10469877 | ||
Funding | This work was supported by Novartis Pharmaceuticals Corporation. The funder of this study, in agreement with the authors and the study steering committee members, designed this study. Representatives of the trial sponsor performed data collection and the subsequent analysis. | PMC10469877 | ||
Availability of data and materials | Novartis made the study protocols available for MONALEESA-3 at the time of primary publications. Individual participant data will not be made available. | PMC10469877 | ||
Declarations | PMC10469877 | |||
Ethics approval and consent to participate | All patients provided written informed consent. This trial was conducted in accordance with the Good Clinical Practice guidelines and Declaration of Helsinki. An independent ethics committee or institutional review board at each site approved the study protocol and any modifications. The study conduct was supervised by... | PMC10469877 | ||
Consent for publication | All named authors have contributed to the manuscript and agreed to its submission. | PMC10469877 | ||
Competing interests | TG, MM | ONCOLOGY, PAF | PN has nothing to disclose. PAF reports personal fees for advisory boards and invited speaker fees from Novartis, Pfizer, Daiichi Sankyo, AstraZeneca, Eisai, Merck Sharp & Dohme, Lilly, Seagen, Roche, and Gilead; institutional funding from BioNTech and Cepheid; research grant from Pfizer; and personal fees for advisory... | PMC10469877 |
References | PMC10469877 | |||
Abstract | Nutrition‐sensitive | EVENTS, UNDERNUTRITION | Bangladesh struggles with undernutrition in women and young children. Nutrition‐sensitive agriculture programmes can help address rural undernutrition. However, questions remain on the costs of multisectoral programmes. This study estimates the economic costs of the Targeting and Re‐aligning Agriculture to Improve Nutr... | PMC9749601 |
Key messages | Nutrition‐sensitive agriculture programmes | UNDERNUTRITION |
Nutrition‐sensitive agriculture programmes can improve rural undernutrition but lack information on costs.We use a standardised approach to estimate the total incremental costs of an integrated nutrition intervention in Bangladesh to improve maternal and child undernutrition.Costs per household compare favourably with... | PMC9749601 |
BACKGROUND | Nutrition‐sensitive, overnutrition, stunting, malnutrition | CHILD MALNUTRITION, OVERNUTRITION, UNDERNUTRITION, UNDERNOURISHED, MALNUTRITION, WASTED | Child and maternal malnutrition is a persistent problem in Bangladesh. The prevalence of stunting in Bangladesh is 31% for children under 5, with 9% severely stunted and 2% severely wasted. Further, children in rural areas of the country are more likely to be stunted than their counterparts in urban areas. In Banglades... | PMC9749601 |
The TRAIN intervention | BCC, APPENDIX | TRAIN was a 3.5‐year project (2016−2020) designed to address evidence gaps on agriculture‐based interventions to improve maternal and child nutrition. BRAC started the programme in 2016 in the Dhaka, Khulna and Rangpur divisions. A total of 5040 households were selected from 144 unions of 36 Subdistricts from 10 distri... | PMC9749601 | |
METHODS | APPENDIX | This study used a novel standardised costing approach that contributes to gaps in the literature on the costs of multisectoral nutrition programmes (Margolies et al., The cost analysis was conducted from the payer and societal perspectives. The analysis included costs incurred by BRAC, frontline workers and programme b... | PMC9749601 | |
Data collection | EVENTS, SECONDARY, MAY | The cost analysis captures the total costs of the TRAIN intervention incremental to the existing microcredit programme. Primary and secondary cost data were collected for the period of October 2016−January 2020, which included 6 months of start‐up and 3 years of full implementation. The SEEMS mixed‐methods approach com... | PMC9749601 | |
Data analysis | SECONDARY | We analysed secondary expenditure and process evaluation data and combined these with primary data on economic costs. First, we analysed process evaluation data on beneficiary time allocation and OOP expenditures for participating households using Stata 16 statistical software. Second, we obtained financial expenditure... | PMC9749601 | |
Personnel costs | APPENDIX | First, all nonshared financial and economic personnel costs were allocated across programme activities. We combined expenditure and time allocation data from BRAC staff and frontline workers (IDIs and FGDs). This information was used to allocate personnel costs to programme activities (Supporting Information: Appendix ... | PMC9749601 | |
Economic costs of frontline workers | Estimates of frontline worker (PK) costs include personnel costs from BRAC expenditures combined with estimates of OOP costs and the valuation of time above the contracted 36‐h week. Economic costs such as OOPs and overtime hours/travel were not reimbursed by BRAC. PK personnel costs, gleaned from both financial expend... | PMC9749601 | ||
Beneficiary opportunity costs | EVENTS, APPENDIX | Beneficiaries participated in programme activities such as household counselling and community events. We estimated the opportunity costs of participation in TRAIN activities from process evaluation data. Opportunity costs were based on information on beneficiaries’ OOP expenses and the average time per year spent on p... | PMC9749601 | |
Start‐up and capital costs | One‐time start‐up costs, capital and equipment costs for durable goods valued over USD$100 and lasting over 1 year were annuitized. These costs were annuitized over the implementation period using a discount rate of 3% and an expected useful life of 10 years. Annuitization ensures an equivalent annual cost is estimated... | PMC9749601 | ||
Unit costs | Total incremental costs were broken down by their financial and economic components. The total incremental cost per beneficiary is defined as the total cost divided by the total number of beneficiaries. We also present cost breakdowns by intervention typology, programme activity, inputs and timing (start‐up and recurre... | PMC9749601 | ||
Sensitivity analyses | A Monte Carlo probabilistic sensitivity analysis was performed using Oracle's Crystal Ball software (Overtime and OOP expenses for frontline workers (PKs): The estimate of overtime includes labour and travel time that was not reimbursed during the salaried work week. PK overtime varied by geographical location and by w... | PMC9749601 | ||
RESULTS | The total incremental cost of the TRAIN programme including economic and financial costs over 3.5 years was USD$795,040.34 (Table Summary of total incremental costs for the TRAIN intervention (USD, 2019)Abbreviation: TRAIN, Targeting and Realigning Agriculture to Improve Nutrition. | PMC9749601 | ||
Cost drivers | Figure Cost drivers for the TRAIN intervention in Bangladesh by activity type (Source: Authors). TRAIN, Targeting and Realigning Agriculture to Improve Nutrition.The main costs disaggregated by input category were dominated by personnel (68%), 48% of which came from hired labour. The remaining 20% of personnel costs re... | PMC9749601 | ||
Costs by treatment arm | Total incremental costs per household per year ranged from a minimum of USD$36.62 (arm 2, only nutrition components) to a maximum of USD$87.50 for arm 4, which included all programme components (nutrition, nutrition‐sensitive agriculture, and gender). Arm 3 included two components—nutrition and nutrition‐sensitive agri... | PMC9749601 | ||
Sensitivity analyses | The tornado diagram shown in Figure Tornado plot from the sensitivity analysis for total incremental costs | PMC9749601 | ||
DISCUSSION | household‐level, two‐thirds | EVENTS, BCC, SENSITIVITY | Integrated agriculture and nutrition interventions can provide effective platforms to reach vulnerable populations (Ruel et al., For intervention unit costs, the average incremental cost per household was USD$63.10 regardless of the treatment arm. Similar to most nutrition‐sensitive programmes, TRAIN provided benefits ... | PMC9749601 |
CONCLUSIONS | This study presents the financial and economic incremental costs of implementing an integrated agriculture‐nutrition intervention through a micro‐credit platform in Bangladesh. Cost‐per beneficiary estimates compare favourably with multisectoral nutrition‐sensitive interventions implemented through different platforms.... | PMC9749601 | ||
AUTHOR CONTRIBUTIONS | Giang Thai led data collection and cost analyses and contributed to the manuscript. Amy Margolies contributed to the cost study methodology, conducted cost analyses and led drafting of the manuscript. Aulo Gelli contributed to the cost study methodology and to conception and design, provided technical advice, drafted a... | PMC9749601 | ||
CONFLICT OF INTEREST | The authors declare no conflict of interest. | PMC9749601 | ||
Supporting information | Supplementary information.Click here for additional data file. | PMC9749601 | ||
ACKNOWLEDGEMENTS | We would like to thank BRAC employees and staff in Bangladesh for their collaboration on this study. This study was supported, in whole or in part, by the Bill & Melinda Gates Foundation (INV‐00808). Additional support was provided by the CGIAR Programme on Agriculture for Nutrition and Health (A4NH).Microcredit is a f... | PMC9749601 | ||
DATA AVAILABILITY STATEMENT | Data available on request from the authors. | PMC9749601 | ||
REFERENCES | PMC9749601 | |||
Subject terms | stroke, Upper-extremity impairment, post-stroke, upper-extremity impairment | ADVERSE EVENTS, STROKE, CORTEX | Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. In this open-label, non-randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with renewed physical rehabilitation to promote functional reorg... | PMC10504081 |
Main | stroke, Ischemic stroke, post-stroke, traumatic | SAID, STROKE, ISCHEMIC STROKE | Ischemic stroke can have devastating consequences to individuals and their families while simultaneously carrying a high social and economic burden. Major advances have been achieved in prevention and treatment of stroke by means of population-health management of risk factors and acute interventions. Innovation and de... | PMC10504081 |
Illustrated overview of dentatothalamocortical pathway depicting a single deep brain stimulation lead implanted in the left dentate nucleus (brown). | stroke, upper-extremity motor impairment, impaired post-stroke, disability, upper-extremity impairment | ADVERSE EVENTS, STROKE, EVENT, CEREBRAL ISCHEMIA, SECONDARY, CORTEX | The crossed dentatothalamic projections (blue in upper-left illustration) terminate across multiple contralateral thalamic (green) nuclei that, in turn, project (orange), to broad regions of cerebral cortex. The dentatothalamocortical pathway represents the ascending component of a robust, reciprocal loop interconnecti... | PMC10504081 |
Results | PMC10504081 | |||
Patient disposition | upper-extremity hemiparesis, post-stroke, ischemic stroke | ISCHEMIC STROKE | Electronic medical record screening was used to identify individuals with a first-time, unilateral, ischemic stroke affecting the middle cerebral artery territory, sparing the diencephalon and basal ganglia, 12–36 months before surgery. Each candidate had to show persistent moderate-to-severe upper-extremity hemiparesi... | PMC10504081 |
Primary outcomes: safety and feasibility | ADVERSE EVENTS, ADVERSE EVENT | The study accumulated 168 participant-months of DBS implant experience and 72 months of DN stimulation experience, with no device failures and no study-related, serious adverse events throughout the trial. A total of 51 adverse events were recorded during the trial, including 21 deemed related to study participation. T... | PMC10504081 | |
Secondary outcomes: motor impairment and function | reductions in impairment, Depression, Anxiety | SECONDARY | Our evaluation of changes in motor impairment and function during the trial focused primarily on differences observed across five key intervals (Fig. To learn if reductions in impairment would be associated with gains in function, given that both are important indicators of recovery, we also evaluated surgical and trea... | PMC10504081 |
Effect of distal motor function preservation at enrollment | A post hoc analysis was performed to characterize the effect of level of preservation of distal motor function at enrollment on treatment-related changes in impairment and function. Preservation was defined as the presence, at screening, of active extension of the wrist and two digits plus active thumb abduction/extens... | PMC10504081 | ||
Effect of time post-stroke on treatment-related gains | post-stroke | As it is generally considered that there is an optimal period for facilitating post-stroke motor recovery, marked by a nonlinear process that begins to plateau by several months after injury | PMC10504081 | |
Discussion | post-stroke, physical disability, reduction of motor impairment, chronic post-stroke hemiparesis, post-stroke motor impairment, disability | SECONDARY, PHYSICAL DISABILITY | Data from this phase I trial of 12 individuals with chronic, moderate-to-severe post-stroke motor impairment support the safety and feasibility of chronic stimulation of the ascending cerebellothalamocortical pathway. Furthermore, it provides an in-human demonstration of significant and clinically meaningful effects of... | PMC10504081 |
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