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2.7. Sample Preparation | The frozen urine samples were thawed at room temperature and subjected to different extraction procedures and analytical methods based on the compound of interest. A brief description of these procedures is provided below.Urinary tartaric acid was measured after slightly modifying and validating a previously published ... | PMC10419126 | ||
2.8. LC-MS/MS Conditions | The LC-MS/MS system comprised liquid chromatography (Shimadzu, MD, USA) with a binary pump (LC-30AD), an autosampler (SIL-30AC), a controller (CBM-20A) and an ABSciex QTRAP 5500 mass spectrometer (SCIEX, Redwood City, CA, USA). The chromatograms were monitored using Analyst 1.7, and the data were analyzed using MultiQu... | PMC10419126 | ||
2.9. Statistical Analysis | Standard least squares models were used to test the fixed effects of treatment (grape and placebo), time (a.m. and p.m.), and time period (baseline, 1 h and 1–6 h period), and their interactions on urine biomarkers F2-isoprostane and grape metabolite concentrations. Biomarker values were not normally distributed; thus,... | PMC10419126 | ||
3. Results | PMC10419126 | |||
3.1. Participant Characteristics | Forty-eight individuals responded to the study advertisement and were screened by telephone. Sixteen of these people did not enroll in the study due to scheduling conflicts, lack of response to invitations for an in-person screening and declining to perform study activities ( | PMC10419126 | ||
3.2. Biomarker Response to Treatment | PMC10419126 | |||
3.2.1. Urine F2-Isoprostane Concentration | F-2 isoprostane levels (ng/mg creatinine) showed main effects of time period (baseline < 1-h < 1–6-h, Expressed as % of baseline, F2-isoprostane levels were higher in the a.m. vs. p.m. (Total post-meal F2-isoprostane excretion (sum of 1 h and 1–6 h) showed a main effect of time (a.m. > p.m., F2-isoprostane levels were ... | PMC10419126 | ||
3.2.2. Urine Grape Metabolite Concentrations | PMC10419126 | |||
Relationship of F2-Isoprostane to Grape Metabolites | REGRESSION | Overall, without respect to treatment or time variables, urine total F2-isoprostane levels were inversely related to urine total tartaric acid (RLinear regression analysis indicated that the impact of each treatment (grape and placebo) and time (a.m. and p.m.) group for the post-mealtime periods on F2-isoprostane level... | PMC10419126 | |
3.3. Dietary Assessment | The usual dietary intake of the participants is shown in Participant adherence to the low-antioxidant diet (the two days preceding each laboratory visit) was confirmed by examining food records, which showed the avoidance of high-antioxidant foods and beverages and selection of the recommended low-antioxidant items. In... | PMC10419126 | ||
4. Discussion | rheumatoid arthritis, metabolic disease | RHEUMATOID ARTHRITIS, REGRESSION, OXIDATIVE STRESS, METABOLIC DISEASE | The findings of this study support the hypothesis that the timing of grape consumption modulates the body’s response to an oxidative stress challenge. Higher F2-isoprostane urine excretion following consumption of a high-fat meal was seen in the morning compared to the evening, and this response was blunted by co-inges... | PMC10419126 |
Supplementary Materials | The following supporting information can be downloaded at Click here for additional data file. | PMC10419126 | ||
Author Contributions | Conceptualization, C.B.; methodology, C.B. and A.A.-H.; data analysis, C.B., A.A.-H., B.G. and S.K.P.; investigation, C.B., A.A.-H., B.G. and S.K.P.; writing—original draft preparation, C.B., A.A.-H. and B.G.; writing—review and editing, C.B., A.A.-H., B.G. and S.K.P.; project administration, C.B. and A.A.-H.; funding ... | PMC10419126 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board, Human Subjects Committee of Idaho State University, protocol IRB-FY2021-264. | PMC10419126 | ||
Informed Consent Statement | Informed consent was obtained from all participants involved in the study. | PMC10419126 | ||
Data Availability Statement | The data presented in this article may be requested from the corresponding author. The protocol is available at ClinicalTrials.gov ( | PMC10419126 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10419126 | ||
References | Cancer | CANCER | Participant flow through study protocol.F-2 Isoprostane excretion (corrected for creatinine) expressed as % of baseline. Levels were higher in the a.m. vs. p.m. and at 1–6 vs. 1 h time periods. * Main effects of time and time period, Total post-meal F2-isoprostane excretion as % of baseline. Time effect: a.m. > p.m., *... | PMC10419126 |
1. Introduction | gastric cancer, cancer, Cancer | GASTRIC CANCER, INFLAMMATORY RESPONSE, INFLAMMATION, CANCER, GASTRIC CANCER, MALIGNANCIES, COMPLICATIONS, CANCER | These authors contributed equally to this work.Objective: The impact of perioperative immunonutrition on patients undergoing radical gastrectomy remains undetermined. This study aimed to assess the influence of enteral immunonutrition support on postoperative immune function and intestinal mucosal barrier function foll... | PMC10647624 |
2. Materials and Methods | PMC10647624 | |||
2.1. Study Participants | MALIGNANCIES, GASTRIC CANCER | This study is a single-center, prospective, randomized investigation aimed at assessing the efficacy of perioperative immunonutrition in patients undergoing radical gastrectomy for gastric cancer. The cohort encompassed patients who underwent radical gastrectomy from June 2022 to June 2023 at the Peking Union Medical C... | PMC10647624 | |
2.2. Methods of Perioperative Nutritional Support for Both Groups | This investigation was a prospective, randomized clinical trial conducted at the Peking Union Medical College Hospital. Patients were randomized to one of two enteral nutrition protocols. Entenal immnuonutrition (PROSURE group: EIN, n = 30) was administered in the first group, a liquid diet providing 1.26 kcal/mL and 6... | PMC10647624 | ||
2.3. Detection of Observation Indicators | Peripheral venous blood samples | SECONDARY, POSTOPERATIVE COMPLICATIONS | The primary endpoint was postoperative complications. The secondary endpoints encompassed parameters such as nutritional status, inflammatory markers, cellular immune function indicators, and intestinal mucosal barrier integrity indicators, notably endotoxin (ET), D-lactic acid, and diamine oxidase. Peripheral venous b... | PMC10647624 |
2.4. Evaluation Indicators | POSTOPERATIVE COMPLICATIONS | Comparisons were undertaken between the groups concerning demographic data, postoperative rehabilitation, postoperative complications (Clavien-Dindo ≥ 2), and indicators of the intestinal mucosal barrier on the 3rd and 7th postoperative days, including D-lactic acid, diamine oxidase, and endotoxin. Peripheral blood inf... | PMC10647624 | |
2.5. Statistical Methods | COMPLICATIONS | The primary endpoint of the study was complications after gastrectomy. The anticipated non-occurrence rate for complications was projected at 80%, and its compared group was 60%. With an 80% statistical power and a one-sided type I error rate of 5%, a sample size of 21 patients was determined using Simon’s two-stage de... | PMC10647624 | |
3. Results | PMC10647624 | |||
3.1. General Information | gastric cancer | GASTRIC CANCER | Sixty-five patients undergoing radical gastrectomy for gastric cancer were included in this study, with 30 in the study group and 35 in the control group. | PMC10647624 |
3.3. Comparison of Postoperative Rehabilitation between the Two Groups | The intervals to the first flatus and first bowel movement for both groups are detailed in | PMC10647624 | ||
3.6. Comparison of Postoperative Nutritional Indicators between the Two Groups | On the 7th postoperative day, as depicted in | PMC10647624 | ||
4. Discussion | cancer, intestinal mucosal injury, tumors | GASTRIC CANCER, PHYSIOLOGICAL STRESS, POSTOPERATIVE COMPLICATIONS, CANCER, CAVITY, TUMORS | Gastric cancer, a predominant digestive system malignancy, frequently emerges with late diagnoses and challenging therapeutic measures in China. Modern therapeutic paradigms underscore a comprehensive treatment anchored in surgical interventions [The intestinal mucosal barrier serves a dual role: it facilitates the tra... | PMC10647624 |
Author Contributions | Conceptualization, M.M. and W.K.; methodology, M.M. and Z.Z. (Zicheng Zheng); software, M.M.; formal analysis, M.M. and Z.Z. (Ziyang Zeng); investigation, Z.Z. (Zicheng Zeng); resources, X.Y. and W.K.; data curation, J.L.; writing—original draft preparation, M.M. and Z.Z. (Zicheng Zheng); writing—review and editing, W.... | PMC10647624 | ||
Institutional Review Board Statement | The present study was approved by the Institutional Review Board of the Peking Union Medical College Hospital. The ethical approval code of this study is no. KS2022530. The date of approval is 9 February 2022. Registration number was ChiCTR2300071079. | PMC10647624 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. Written informed consent has been obtained from the patient(s) to publish this paper. | PMC10647624 | ||
Data Availability Statement | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10647624 | ||
Conflicts of Interest | The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. | PMC10647624 | ||
References | COMPLICATIONS, POSTOPERATIVE COMPLICATIONS | The flowchart of our study.The comparison of general characteristics between the two groups.Abbreviations: SD, standard deviation; BMI, body mass index.Comparison of DAO, D-lactic acid, and endotoxin between the two groups after operation.Comparison of postoperative rehabilitation between the two groups.Comparison of p... | PMC10647624 | |
Background | mental illness, comorbidity, SMI | Clients with severe mental illness (SMI) have overall poor physical health. SMI reduces life expectancy by 5–17 years, primarily due to physical comorbidity linked to cardiometabolic risks that are mainly driven by unhealthy lifestyle behaviours. To improve physical health in clients with SMI, key elements are systemat... | PMC10504705 | |
Methods | metabolic syndrome | METABOLIC SYNDROME | The GILL study encompasses a cluster-randomised controlled trial in approximately 20 mental health care facilities in the Netherlands. The randomisation takes place at the team level, assigning clients to the eHealth intervention or the usual care group. The GILL eHealth intervention consists of two complementary modul... | PMC10504705 |
Discussion | The GILL eHealth intervention is expected to be more effective than usual care in improving physical health and lifestyle behaviours among clients with SMI. It will also provide important information on implementation of GILL eHealth in mental health care. If proven effective, GILL eHealth offers a clinically useful to... | PMC10504705 | ||
Trial registration | Clinical trial registration NCT05533749, registration date: 8 September 2022. | PMC10504705 | ||
Keywords | PMC10504705 | |||
Background | illness, mental illness, SMI | DISEASES | Clients with severe mental illness (SMI) have overall poor physical health. SMI reduces life expectancy by 5–17 years [To improve physical health in clients with SMI, key elements are comprehensive somatic screening and lifestyle promotion [Use of eHealth can significantly contribute to effective implementation of prog... | PMC10504705 |
Methods | PMC10504705 | |||
Study design | A multicentre, cluster-randomised controlled trial (RCT) with an embedded process evaluation on the execution of the GILL eHealth intervention. | PMC10504705 | ||
Setting | RECRUITMENT | Approximately 20 mental healthcare facilities (FACT teams, assisted facilities and long-stay wards of mental hospitals) will participate in this study. The total amount of teams will depend on the recruitment rate. When the enrolment of participants is falls short, additional teams will be added. Teams will be recruite... | PMC10504705 | |
Participants | The study population will consist of adults with SMI, according to the definition of Delespaul [ | PMC10504705 | ||
Randomisation | Randomisation will take place at the team level, to avoid contamination between the intervention and control groups. Before the inclusion of clients, participating teams will be randomly assigned to the GILL eHealth intervention or the control group providing care as usual. This procedure will be performed by a statist... | PMC10504705 | ||
Recruitment | To recruit the eligible clients, teams will compose a list of clients who meet the inclusion and exclusion criteria. Eligible clients will be asked whether they are interested in participating in this study. After giving permission, clients will be approached by the research team and further information about the study... | PMC10504705 | ||
GILL eHealth intervention | The GILL eHealth intervention was developed by two nurse practitioners and a professor of mental health nursing. The content is developed in accordance with the 2015 national guidelines on somatic screening and lifestyle intervention for clients with SMI [ | PMC10504705 | ||
OurGILL | extrapyramidal movement disorders, ’ psychiatric | The OurGILL module focuses on systematic (i.e. in design, frequency, and imbedding in daily care) and comprehensive somatic screening, and promotes the prevention, early recognition, and treatment of physical problems. It aims to assess clients’ psychiatric condition, physical symptoms and complaints, medication use an... | PMC10504705 | |
MyGILL | The MyGILL module is aimed at lifestyle behaviours, including nutrition, physical activity, sleep, relaxation, substance use and addiction, personal hygiene, smoking, sex life, and social support. The result is an overview of the client’s performance in these lifestyle areas. This facilitates drawing up a personalised ... | PMC10504705 | ||
Usual care | The teams assigned to the control group will not receive any training and will provide care as usual. Clients in the usual care group will have unrestricted access to mental and general health care, but are not allowed to participate in a structured lifestyle programme for the duration of the study. National guidelines... | PMC10504705 | ||
Training of care managers | The GILL eHealth intervention will be conducted by trained coordinating nurses, who will perform the role of ‘care manager’ for physical health and lifestyle. Two nurses of each team in the experimental condition will receive a one-day training focused on the theoretical background of physical health care and lifestyle... | PMC10504705 | ||
Main study outcomes | PMC10504705 | |||
Primary outcome | metabolic syndrome, Metabolic Syndrome | METABOLIC SYNDROME, METABOLIC SYNDROME | Primary outcome of this study is metabolic syndrome severity, and is operationalised by the Metabolic Syndrome Severity Score (MSSS) at 12 months as defined by Gurka et al. [ | PMC10504705 |
Secondary outcomes | Secondary clinical outcomes are weight (kg), BMI (kg/m2), diastolic blood pressure, lipid profiles (LDL, total cholesterol), and HbA1c. Participants will also perform a six-minute walk test (6MWT) to assess physical fitness [ | PMC10504705 | ||
Client reports | NRS | Several client reports will be used in this study. The International Physical Activity Questionnaire Short Form (IPAQ-SF) [Perceived satisfaction with physical health, physical activity, and healthy eating will be measured using a numeric rating scale (NRS), with a score ranging from 0 to 10. The self-assessment concer... | PMC10504705 | |
Clinician-rated | Psychosocial functioning will be measured with the Health of the Nation Outcome Scale (HoNOS) [ | PMC10504705 | ||
Demographics | psychiatric | DISEASES | Demographic and clinical data (i.e., age, gender, ethnicity, marital status, educational level, employment status, psychiatric diagnoses, diagnoses of physical diseases, current smoking status) will be obtained at baseline to describe our sample, to control for possible confounders, to determine the MSSS, and to analys... | PMC10504705 |
Process evaluation | This study also includes a qualitative process evaluation at the client and nurse level. Barriers and facilitators for effective use and implementation of GILL eHealth will be investigated. At the client level the goal is to understand participants’ experiences and perceptions with GILL eHealth, their responses to the ... | PMC10504705 | ||
Sample size | metabolic syndrome | METABOLIC SYNDROME | This RCT is powered to detect a mean difference of at least 0.40 in the metabolic syndrome severity Z score across 1 year between the intervention and control group. The mean difference in the metabolic syndrome severity Z score is estimated on the basis of earlier intervention studies [ | PMC10504705 |
Statistical analysis | metabolic syndrome, Mets | METABOLIC SYNDROME | Baseline data will be presented comparing the two treatment groups. Both intention-to-treat and per-protocol analysis will be conducted. To test the hypothesis that the tailored eHealth intervention will result in improved metabolic syndrome severity in SMI clients compared to usual care, linear mixed models will be us... | PMC10504705 |
Analysis process evaluation | To objectify the process evaluation, interviews will be audio recorded, transcribed verbatim for analysis. MAXQDA software will be used for coding and structuring themes, following methodology of thematic analysis [ | PMC10504705 | ||
Discussion | psychotic disorder | Limited eHealth-supported lifestyle interventions are available for clients with SMI, tailored to their specific needs and characteristics. However, given the overall burden of poor physical health on clients with SMI [A strength of this study is its pragmatic design. The study will be conducted in mental health teams ... | PMC10504705 | |
Acknowledgements | Not applicable. | PMC10504705 | ||
Monitoring | To monitor adherence to the intervention protocol, the research team will gain insight in the GILL modules. There are no further mandatory actions for the intervention. An independent monitor of the Amsterdam UMC Clinical Monitoring Center will control adherence to the research protocol and good clinical practice guide... | PMC10504705 | ||
Dissemination policy | Trial results will be reported to by letters to participants. Presentations for the mental healthcare facilities will be organized, and results will be presented at conferences. Furthermore, results will be shared in open access publications. The authors will be members of the research group, and will not involve profe... | PMC10504705 | ||
Authors’ contributions | MH | BvM and MA designed the study protocol. MH participated in the design of the study and drafted the manuscript. BvM, AB, and MA obtained funding for this study. All authors participated in the revisions of successive drafts of the manuscript and approved the final version. | PMC10504705 | |
Funding | This study was supported by a grant from the Netherlands Organisation for Health Research and Development, ZonMw (grant no. 10040022010002). The funder had no role in the design or execution of the study, data collection, analysis and interpretation, decision to publish, or writing of the manuscript. The Amsterdam Univ... | PMC10504705 | ||
Availability of data and materials | This study will use a data-management infrastructure that meets current guidelines and regulations. After the final publication, the protocol, all data, and the statistical code will be available upon request. | PMC10504705 | ||
Declarations | PMC10504705 | |||
Ethics approval and consent to participate | The study protocol has been evaluated and approved by the Ethics Committee of VU University Medical Center (NL81729.029.22, registration no. 2022.0793) and will be conducted in conformity with the principles of the Declaration of Helsinki (version 2008) and the Dutch Medical Research Involving Human Subjects Act (WMO).... | PMC10504705 | ||
Consent for publication | Not applicable. | PMC10504705 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10504705 | ||
References | PMC10504705 | |||
Keywords | Communicated by Francesco Lacquaniti.Weak transcranial direct current stimulation (tDCS) is known to affect corticospinal excitability and enhance motor skill acquisition, whereas its effects on spinal reflexes in actively contracting muscles are yet to be established. Thus, in this study, we examined the acute effects... | PMC10224818 | ||
Introduction | Weak transcranial direct current stimulation (tDCS, 1–4 mA) alters corticospinal excitability (Nitsche and Paulus The impact of tDCS on the function and excitability of spinal cord pathways has not been well established. The Hoffmann-reflex (H-reflex), the electrical analog of the spinal stretch reflex, is a measure of... | PMC10224818 | ||
Methods | PMC10224818 | |||
Participants | neurological impairments | Fourteen young adults (9 females and 5 males, mean age = 26.1 years, range 21–36) with no known neurological impairments completed the protocol, which consisted of four sessions of tDCS (Active or Sham) + repeated soleus H-reflex elicitation. Prior to participation, all participants provided written informed consent to... | PMC10224818 | |
tDCS | Each participant was randomly assigned to the Active or Sham tDCS group prior to the first experimental session without the participant’s knowledge. They remained in the same group for all 4 study sessions (parallel, single-blinded). The tDCS was applied at the “M1 hotspot”, which was determined for each participant in... | PMC10224818 | ||
EMG recording and tibial nerve stimulation | EMG signal was recorded from the soleus and its antagonist tibialis anterior (TA) of the leg stimulated. Pairs of self-adhesive surface Ag–AgCl electrodes (2.2 × 3.5 cm, Nissha Medical Technologies, Buffalo, NY) were placed with their centers ~ 3 cm apart. The pair of soleus electrodes were placed just below the gastro... | PMC10224818 | ||
Data analysis | A custom MATLAB (MathWorks Inc., Natick, MA) program was used to analyze the EMG data offline. To measure the soleus and TA pre-stimulus (i.e., background: BG) EMG, the EMG signal was full-wave rectified and the mean absolute EMG amplitude was calculated for the 50 ms immediately before stimulation. Soleus H-reflex and... | PMC10224818 | ||
Results | PMC10224818 | |||
Stability of experimental (data collection) condition | The soleus MSoleus BG EMG (mean of 26 ± 8 μV), TA BG EMG (≈8 μV, corresponding to a resting level) and soleus M-wave size (mean of 0.45 ± 0.02 mV), the stability of which is essential in assessing changes in H-reflex size across multiple measurement time points, remained stable across measurements. For soleus BG, when ... | PMC10224818 | ||
Effects of tDCS on the soleus H | Across both groups of participants, the H | PMC10224818 | ||
Discussion | Here, we examined the impact of tDCS delivered during an active motor task on the excitability of a spinal reflex pathway. The size of soleus submaximal H-reflex showed some rapid and temporary changes during 30-min of tDCS over the leg M1. During the first minutes of Active and Sham tDCS, H-reflex size increased, and ... | PMC10224818 | ||
Rapid increase in H-reflex size with both Active and Sham tDCS | Unexpectedly, we found with both Active and Sham tDCS, submaximal H-reflexes measured at one minute after tDCS onset (i.e., T1, the measurement started 30 s after the ramp-up was completed for the Active tDCS group and at the end of ramp-down for the Sham tDCS group) were, on average, about 6% larger than the pre-tDCS ... | PMC10224818 | ||
Rapid return of H-reflex excitability to the baseline level | The return (i.e., decrease) of H-reflex size from the initial increase was significant over all participants and appeared to occur sooner among the Active tDCS group participants than the Sham group (Fig. Interestingly, once the H-reflex decreased back to the pre-tDCS level, with Active tDCS, the continuation of positi... | PMC10224818 | ||
Implications | COMPLICATION | The ability of tDCS to induce CNS plasticity, measured with, for example, MEPs, fMRI, EEG, and brain derived neurotrophic factor level (Fritsch et al. In the present study, we observed that the excitability of soleus H-reflex pathway was briefly increased by both Active and Sham tDCS applied during standing, and then, ... | PMC10224818 | |
Methodological considerations and limitations | CORTEX | Several methodological concerns and limitations in this study warrant discussions. One of the main findings of this study is that during the first minutes of Active and Sham tDCS, H-reflex size increased. Since several prior studies, in which soleus reflexes were repeatedly elicited over the course of 30–40 min, found ... | PMC10224818 | |
Acknowledgements | The authors wish to thank Roland Cote, Blair Dellenbach, Markus Melvin, Michelle McLeod, Alan Phipps and Bridgette Pouliot for their support and encouragement during challenging times. The authors also wish to thank Kirstin-Friederike Heise for valuable statistical advice. | PMC10224818 | ||
Author contributions | LMM conceived the study. LMM, JRW and AKT were responsible for the design. LMM performed the experiments and the analysis. LMM, JRW and AKT interpreted the results. LMM drafted the manuscript. LMM, JRW and AKT edited the manuscript. All authors approved the final version submitted and are accountable for all aspects of... | PMC10224818 | ||
Funding | NS114279, Stroke, Neurological Disorders | SPINAL CORD, STROKE, NEUROLOGICAL DISORDERS | This work was supported in part by the National Institute of Neurological Disorders and Stroke [NS114279 to AKT], the National Institute of Biomedical Imaging and Bioengineering [P41-EB018783 to JRW], the Eunice Kennedy Shriver National Institute of Child Health and Human Development [P2C HD086844 to Kautz], the New Yo... | PMC10224818 |
Data availability | Study data is available upon request. | PMC10224818 | ||
Declarations | PMC10224818 | |||
Conflict of interest | The authors declare no competing financial interests. | PMC10224818 | ||
References | PMC10224818 | |||
Background | cancer, sarcomas | CANCER, SARCOMAS | Cell-based immunotherapy shows the therapeutic potential in sarcomas, in addition to angiogenesis-targeted tyrosine kinase inhibitor (TKI) and immune checkpoint inhibitor (ICI). Multi-antigen stimulated cell therapy-I (MASCT-I) technology is a sequential immune cell therapy for cancer, which composes of multiple antig... | PMC10687909 |
Methods | In this phase 1 study, we assessed MASCT-I plus camrelizumab (an ICI against PD-1) and apatinib (a highly selective TKI targeting VEGFR2) in patients with unresectable recurrent or metastatic bone and soft-tissue sarcoma after at least one line of prior systemic therapy. One MASCT-I course consisted of 3 DC subcutaneou... | PMC10687909 | ||
Results | From October 30, 2019, to August 12, 2021, 19 patients were enrolled and randomly assigned to schedule-I group ( | PMC10687909 |
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