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CONFLICT OF INTEREST STATEMENT | The authors declare no actual or potential conflicts of interest that could influence this study. | PMC10519819 | ||
Ethics Statement | This study was approved (2023023H) by the Sports Science Experimental Ethics Committee of Beijing Sport University. Informed consent forms were provided and signed by all participants before participating in this study. | PMC10519819 | ||
Supporting information |
Tables S1–S8.
Click here for additional data file. | PMC10519819 | ||
ACKNOWLEDGEMENTS | We thank Xin Wang, Dong‐Mei Yu, Na Zhang, Shuo‐Yan Wang, and all the researchers who provided assistance and advice during our experiments. | PMC10519819 | ||
DATA AVAILABILITY STATEMENT | Data available on request from the authors. | PMC10519819 | ||
REFERENCES | PMC10519819 | |||
Subject terms | anaphylaxis, tumours, cancer, allergic toxicity, toxicity, urticaria | OVARIAN CANCER, ANAPHYLAXIS, TUMOURS, CANCER, URTICARIA | All antibodies approved for cancer therapy are monoclonal IgGs but the biology of IgE, supported by comparative preclinical data, offers the potential for enhanced effector cell potency. Here we report a Phase I dose escalation trial (NCT02546921) with the primary objective of exploring the safety and tolerability of M... | PMC10368744 |
Introduction | cancer | CANCER | All monoclonal antibodies in clinical use for the treatment of cancer belong to the IgG class, the most prevalent immunoglobulin in human blood | PMC10368744 |
Results | PMC10368744 | |||
Dose escalation | SOLID TUMOUR | Patients with any solid tumour expressing FRα using our immunohistochemical assay (Fig. | PMC10368744 | |
Safety | toxicities, pruritus, rash, urticaria | ADVERSE EVENTS, ADVERSE EVENT, EVENTS, URTICARIA | MOv18 IgE was generally well tolerated with the great majority of adverse events being low grade (≤2, NCI Common Terminology Criteria for Adverse Events version 4.0). The most common events were localised cutaneous toxicities including urticaria, pruritus and rash (Fig. | PMC10368744 |
Pharmacodynamics | SKIN | Skin prick testing was routinely performed before each intravenous dose. In general, the reaction to MOv18 IgE in this test was indistinguishable from the negative diluent control, although a wheal reaction of up to 3 mm was also considered negative (Fig. Free FRα protein was detected at one or more time points (baseli... | PMC10368744 | |
Anti-drug antibody responses | Samples for the ADA assay were collected from 26 patients. ADA detection was definitively confirmed, at 1 or 2 time points, in only 3 patients (Supplementary Fig. | PMC10368744 | ||
Pharmacokinetics | Serum MOv18 IgE clearance profiles in each individual patient are shown in Fig. | PMC10368744 | ||
Anti-tumour activity | Twenty of 24 patients, who had at least one on-treatment CT scan, were evaluable for efficacy (Fig. | PMC10368744 | ||
Discussion | Urticaria, anaphylaxis, toxicity, cancer, rash, urticaria, pruritus | HYPERSENSITIVITY REACTIONS, OVARIAN CANCER, ANAPHYLAXIS, URTICARIA, ADVERSE EVENTS, CANCER, URTICARIA, SECONDARY | In this clinical trial of an IgE antibody for the treatment of cancer, a manageable safety profile, distinct from that of IgG drugs, was observed and preliminary evidence of efficacy demonstrated. Both anti-tumour activity and adverse events occurred at doses very much lower than typically observed for IgG antibodies. ... | PMC10368744 |
Methods | PMC10368744 | |||
Study design | toxicity, ovarian cancer, tumour, Cancer | DISEASE PROGRESSION, TUMOUR, OVARIAN CANCER, CANCER | This was an open-label, dose-escalating Phase I study of MOv18 IgE conducted at 4 sites in the United Kingdom. The study was undertaken under the sponsorship and management of the Cancer Research UK Centre for Drug Development, conducted in accordance with International Council for Harmonisation Good Clinical Practice ... | PMC10368744 |
Patients | tumour | RECRUITMENT, TUMOUR, SOLID TUMOUR | Recruitment and treatment took place between 23 February 2016 and 20 April 2021. Eligible patients had advanced or metastatic solid tumours not suitable for alternative standard treatment and were over 16 years of age. Immunohistochemical evidence of tumour FRα membrane expression was required (based on a criterion of ... | PMC10368744 |
Drug administration | Stock, Cancer | ADVERSE REACTIONS, DISEASE, CANCER | Drug was supplied (Cancer Research UK) and manufactured as single-use aseptic 1 mL fill in 2 mL glass vials containing a solution of MOv18 IgE at a concentration of 1 mg/mL at pH6.5 with 0.1 M sodium citrate, 30 g/L L-arginine, 50 g/L sucrose and 0.02% polysorbate 20 in water for injection. Stock was stored at 5 ± 3 °C... | PMC10368744 |
Dose escalation | The planned escalation in successive flat dosing cohorts was 70 μg, 250 μg, 500 μg, 700 μg, 1.5 mg, 3 mg, 6 mg and 12 mg total protein. An accelerated dose escalation scheme, starting with single-patient cohorts, was planned up to cohort 5 (1.5 mg) | PMC10368744 | ||
Cutaneous testing and basophil activation test | SKIN, POSITIVE | Skin prick testing (SPT) with a solution of MOv18 IgE antibody was undertaken in patients prior to each intravenous administration. Positive histamine and negative saline controls were included, and the presence of a wheal reaction in response to the positive control was required for a test to be considered valid (Fig.... | PMC10368744 | |
Other pharmacodynamic assays | allergic toxicity, anaphylaxis, anti-FRα | ADVERSE EVENTS, ANAPHYLAXIS, INFUSION REACTION | No features of anaphylaxis or other manifestation of allergic toxicity were observed in preclinical animal models, but in addition to the risk mitigation steps described above, serial measurements of serum tryptase were included in this trial. Tryptase is released by degranulation of activated effector cells, and eleva... | PMC10368744 |
Pharmacokinetic sampling and assays | Pharmacokinetic blood samples were drawn immediately pre-dose and at 0.5, 2, 4, 6, and 24 h, then 7 days, following the first dose, and 28 and 70 days after the final dose. Serum was separated from blood and stored at −70°C prior to analysis for MOv18 IgE concentrations by indirect ELISA, using a fully validated assay.... | PMC10368744 | ||
Reporting summary | Further information on research design is available in the | PMC10368744 | ||
Supplementary information |
Supplementary InformationPeer Review FileReporting Summary | PMC10368744 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-39679-9. | PMC10368744 | ||
Acknowledgements | Thomas’ NHS, Cancer | CANCER | The trial was funded and sponsored by Cancer Research UK, who collaborated with the academic authors in designing the trial, collated the clinical data, and reviewed the manuscript. The authors acknowledge additional financial support from the UK Department of Health and Cancer Research UK via Experimental Cancer Medic... | PMC10368744 |
Author contributions | allergy | ALLERGY | S.K., H.G., M.F., S.Can., D.J. and J.S. developed MOv18 IgE. J.S. (chief clinical investigator), S.K. (chief scientific investigator), C.C., C.B., P.J. and S.M. wrote the trial protocol. S.Car. and C.Sel. manufactured MOv18 IgE. J.S., S.K., H.B. and J.C. wrote a first draft of the manuscript, and all authors reviewed a... | PMC10368744 |
Peer review | PMC10368744 | |||
Data availability | The summary study data are available within this Article, | PMC10368744 | ||
Competing interests | J.S. and S.K. are co-founders of Epsilogen Ltd. H.B. is presently employed, and J.C. formerly employed, through a fund from Epsilogen Ltd. S.K., H.B., H.G., D.J, G.P. and J.S. hold patents on anti-tumour IgE antibodies. The remaining authors declare no competing interests. | PMC10368744 | ||
References | PMC10368744 | |||
Background | infection | INFECTION | The COVID-19 pandemic is characterized by rapid increases in infection burden owing to the emergence of new variants with higher transmissibility and immune escape. To date, monitoring the COVID-19 pandemic has mainly relied on passive surveillance, yielding biased epidemiological measures owing to the disproportionate... | PMC10437130 |
Objective | This study compared 4 different approaches of active SARS-CoV-2 surveillance focusing on feasibility and epidemiological outcomes. | PMC10437130 | ||
Methods | RECRUITMENT | A 2-factor factorial randomized controlled trial was conducted in 2020 in a German district with 700,000 inhabitants. The epidemiological outcome comprised SARS-CoV-2 prevalence and its precision. The 4 study arms combined 2 factors: individuals versus households and direct testing versus testing conditioned on symptom... | PMC10437130 | |
Results | infections | RECRUITMENT, SARS-COV-2 INFECTION, INFECTIONS | Recruitment was conducted between November 18 and December 11, 2020. The response rates in the 4 arms varied between 34.31% (2340/6821) and 41.17% (2043/4962). The prescreening classified 16.61% (1207/7266) of the patients as COVID-19 symptomatic. Altogether, 4232 persons without prescreening and 7623 participating in ... | PMC10437130 |
Conclusions | This study showed that postal mailing of gargle sample kits and returning home-based self-collected liquid gargle samples followed by high-sensitivity RT-LAMP analysis is a feasible way to conduct active SARS-CoV-2 population surveillance without burdening routine diagnostic testing. Efforts to improve participation ra... | PMC10437130 | ||
Trial Registration | Deutsches Register Klinischer Studien (DRKS) DRKS00023271; https://tinyurl.com/3xenz68a | PMC10437130 | ||
International Registered Report Identifier (IRRID) | RR2-10.1186/s13063-021-05619-5 | PMC10437130 | ||
Introduction | PMC10437130 | |||
Background | VIRUS, ASYMPTOMATIC SARS-COV-2, CONTAGIOUS DISEASE, INFLUENZA | Epidemiological surveillance of populations using serological or nucleic acid–based diagnostics is a well-known public health preparedness tool and is, for example, implemented in the global influenza surveillance network. Here, a system of World Health Organization collaborating centers acts mainly reactively to seaso... | PMC10437130 | |
Objectives | active SARS-CoV-2 infection | The objective of this study was to compare 4 different approaches to population-level surveillance of active SARS-CoV-2 infection and to report the epidemiological outcomes and feasibility. The cost-effectiveness was reported separately [ | PMC10437130 | |
Methods | This study followed the principles of CONSORT (Consolidated Standards of Reporting Trials; extension for multiarm parallel-group randomized trials) statement ( | PMC10437130 | ||
Ethics Approval | The trial was approved by the ethics committee at the University of Heidelberg on November 2, 2020 (amendment November 9, 2020; file number S790/2020). | PMC10437130 | ||
Participation and Informed Consent | DELETION | The study applied the Declaration of Helsinki ethical standards and adhered to the legal requirements for research on humans in Germany as stated in the guidelines for good clinical practice and the Medical Devices Act (Medizinproduktegesetz) issued by the Ministry of Health of Germany and implemented by the Federal In... | PMC10437130 | |
Trial Registration | The trial was registered (November 30, 2020) on the German Clinical Trials Register (registration number DRKS00023271), and the study protocol has been published accordingly [ | PMC10437130 | ||
Study Design | The study was designed as a 2-factor factorial, multiarm parallel randomized controlled trial. The 4 study arms represented all combinations of two factors: i) testing unconditional (A) versus testing under the condition of upstream COVID-19 symptom prescreening (B), and ii) testing individuals (1) versus households (2... | PMC10437130 | ||
Study Setting | The trial was conducted during the second SARS-CoV-2 wave in fall 2020 in Germany in Heidelberg and the Rhine-Neckar district, which is the location of Heidelberg University and the catchment area of the closely cooperating district health authority. The public health authority of the Rhine-Neckar district, also respon... | PMC10437130 | ||
Outcomes | SECONDARY | We considered effectiveness, feasibility, and costs to comprehensively inform policy makers as trade-offs are to be expected when the evidence is reviewed by an evidence-to-decision framework, for example, Grading of Recommendations, Assessment, Development, and Evaluations [The secondary outcomes were the participatio... | PMC10437130 | |
Sample Size | infection | INFECTION | As high-quality test capacity is a limiting resource in active surveillance, we designed the study so that each arm would end up with the same number of laboratory tests, competing for feasibility, effectiveness, and cost-effectiveness. However, a composite end point was not possible, and a priori assumptions regarding... | PMC10437130 |
Randomization | infections | HOLIDAYS, RECRUITMENT, INFECTIONS | A stratified general population representative sample with 2 strata (Rhine-Neckar district plus Heidelberg city) and 2 different sampling approaches (Heidelberg—simple random sample and Rhine-Neckar—2 stage cluster sampling) were used to draw 3 weekly batches to avoid negative impacts on the response rate owing to unce... | PMC10437130 |
Recruitment and Study Materials | -11, RECRUITMENT | Study recruitment started on November 18, 2020, and ended on December 11, 2020, and one-time reminders were sent until December 16, 2020. The general implementation (including testing activities and hotlines) lasted until December 23, 2020.The study website displayed information in 5 languages (German, Turkish, English... | PMC10437130 | |
Logistics | The study arms A1 and A2 immediately received gargle sample collection kits, whereas the study arms B1 and B2 had to complete the prescreening questionnaire first. The differences in logistics in are discussed in detail as follows:Study arm A1: Randomly selected individuals (hereinafter referred to as initially contact... | PMC10437130 | ||
Laboratory and Blinding | To enable scale-up of testing while maintaining sensitivity, an RT-LAMP was used for analyzing the liquid gargle samples. Weakly (<3 replicates positive) and clearly positive gargle samples (all replicates positive) were subsequently analyzed using RT-PCR as a confirmation test [Laboratory staff who conducted the RT-LA... | PMC10437130 | ||
Data Processing | Data cleaning was performed using SAS software (version 9.4 TS1M4; SAS Institute Inc). Statistical analyses were performed using R (version 4.1.1; R Foundation for Statistical Computing) and Stata (version 15.1; StataCorp). | PMC10437130 | ||
Statistical Methods | PMC10437130 | |||
Prescreening Questionnaire | SARS-CoV-2 infection | SARS-COV-2 INFECTION | We developed a symptom screening algorithm using machine learning. The underlying data sets were from various settings with and without SARS-CoV-2 infected patients, including samples from a general population screen and persons tested for SARS-CoV-2 infection because of symptoms or high-risk exposure ( | PMC10437130 |
Descriptive Statistics | Differences in demographics, frequency of COVID-19 symptoms, and epidemiological variables between the trial arms were assessed using the chi-square test and ANOVA (no adjustment for multiple testing). The significance level α was set at 5%. | PMC10437130 | ||
Prevalence Estimation | The total number of SARS-CoV-2 cases was calculated using the Horvitz-Thomson estimator to account for unequal selection probabilities in the 2-stage sampling [ | PMC10437130 | ||
Sensitivity Analysis | The trial was implemented in parallel to the existing passive surveillance system; hence, persons could have been captured by both systems. Some hotline callers refused to participate because they had already tested positive in the passive surveillance. Therefore, we conducted a sensitivity analysis and recalculated th... | PMC10437130 | ||
Results | PMC10437130 | |||
Recruitment | Altogether, 30,629 addresses were provided by 51 municipalities’ registration offices. After excluding duplicates, 27,908 (99.23%) addresses out of the planned sample size of 28,125 were randomly allocated to the arms (Study flowchart. A1: individuals without mandatory prescreening; A2: households without mandatory pre... | PMC10437130 | ||
Outcomes | SARS-COV-2 INFECTION, ASYMPTOMATIC SARS-COV-2 | Although the prescreening was not compulsory in A1 and A2, approximately 92.71% (1894/2043) of the participants in A1 and 81.3% (730/898) of the initially contacted individuals in A2 completed the optional questionnaire. The random forest algorithm classified approximately 16.61% (1207/7266) of the initially contacted ... | PMC10437130 | |
Prevalence Estimates | The weighted prevalence estimates (initial cases only) differed considerably between combined arms A with 0.36% (95% CI 0.14%-0.59%) and B with 0.05% (95% CI 0.00%-0.10%). However, we did not detect a significant difference between the single arms (household members in A2 and B2 included). In A1, the prevalence was 0.3... | PMC10437130 | ||
Discussion | PMC10437130 | |||
Principal Findings | INFECTION TOE | To the best of our knowledge, this is the only study to date that has simultaneously tested different approaches to active SARS-CoV-2 surveillance for the general public based on daily renewed random and population representative samples in a seamless chronology. In this paper, we focused on the feasibility and epidemi... | PMC10437130 | |
Study Participation | throat | MAY | The overall participation rate of 36.57% (10,207/27,908) was lower than the envisaged 50%. First, the complexity of the information material necessary for a 4-arm trial might have been difficult to understand, thereby hindering a timely and appropriate participation [Complementary qualitative data from approximately 80... | PMC10437130 |
Acceptability of Self-Sampling | infections | INFECTIONS | In our study, mail-in gargle self-sampling proved to be feasible. The method was perceived as pleasant, allowed for high test accuracy in asymptomatic patients, and reduced the risk of spreading infections. Liquid gargle sampling was valued as more convenient than nasopharyngeal swabs, and although self-sampling was cu... | PMC10437130 |
Cost-Effectiveness | From an epidemiological perspective, we identified A2 as the most cost-effective strategy, closely followed by A1, based on evidence from a parallel economic evaluation [ | PMC10437130 | ||
Limitations | infection | INFECTION, SARS-COV-2 INFECTION | This study had several limitations. First, the actual execution of the trial was limited to 3 weeks; time constraints limited adequate testing of the prescreening tool and impeded pilot studies. Second, random samples from most municipalities yielded a representative pool of potential participants; however, Heidelberg ... | PMC10437130 |
Active Versus Passive Surveillance | In Germany, the RKI’s COVID-19 figures stem from passive surveillance, aiming to capture all positive test results (tested symptomatic persons and positively tested contact persons) to monitor the pandemic’s progress. However, data are transmitted through multiple tiers from physicians and laboratories to the RKI via l... | PMC10437130 | ||
Conclusions | TB, low infection, HTN, infection, TJA | INFECTION, HTN | The pandemic developed in a highly dynamic manner in most countries, with scarcely comparable trends. The succession of gradually increasing bouts of infection has been interrupted by periods of low infection activity. There is no reason to believe that future pandemics with similar hazard potential will evolve in a le... | PMC10437130 |
Abbreviations | Consolidated Standards of Reporting TrialsRobert Koch Institutereverse transcription loop-mediated isothermal amplificationreal-time reverse transcription–polymerase chain reaction | PMC10437130 | ||
Data Availability | Anonymized data and a data dictionary will be made available in a public repository. Consent forms, invitation letters, and information material for the study are made available upon official request to the Network University Medicine for COVID-19 research in Germany. The study protocol has been published. | PMC10437130 | ||
Background | postoperative pulmonary complications | PULMONARY COMPLICATIONS | Neurosurgical patients represent a high-risk population for postoperative pulmonary complications (PPCs). A lower intraoperative driving pressure (DP) is related to a reduction in postoperative pulmonary complications. We hypothesized that driving pressure-guided ventilation during supratentorial craniotomy might lead ... | PMC10201743 |
Methods | This was a randomized trial conducted between June 2020 and July 2021 at Beijing Tiantan Hospital. Fifty-three patients undergoing supratentorial craniotomy were randomly divided into the titration group or control group at a ratio of 1 to 1. The control group received 5 cmH | PMC10201743 | ||
Results | Fifty-one patients were included in the analysis. The median (IQR [range]) DP in the titration group versus the control group was 10 (9–12 [7–13]) cmH | PMC10201743 | ||
Conclusions | Driving pressure-guided ventilation during supratentorial craniotomy did not contribute to postoperative homogeneous aeration, but it may lead to improved respiratory compliance and lower lung ultrasonography scores. | PMC10201743 | ||
Clinical trial registration | ClinicalTrials.gov NCT04421976. | PMC10201743 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12871-023-02144-7. | PMC10201743 | ||
Keywords | PMC10201743 | |||
Introduction | pulmonary infection | POSTOPERATIVE ATELECTASIS, PULMONARY INFECTION | In neurosurgery, due to the long-term use of general anesthesia and postoperative bed rest, the risk of postoperative atelectasis and pulmonary infection is increased [Optimization of the ventilation strategy can minimize iatrogenic injury in previously healthy lungs, reducing the incidence of PPCs [Electrical impedanc... | PMC10201743 |
Materials and methods | PMC10201743 | |||
Study design | This was a single-center, randomized, parallel group, patient and outcome assessor-blinded trial exploring a ventilation strategy targeting DP during supratentorial craniotomy conducted between June 21, 2020, and July 1, 2021, at Beijing Tiantan Hospital, Capital Medical University. The study adhered to the Consolidate... | PMC10201743 | ||
Study population | respiratory disease, dysphagia, pneumonia, Coma, cranial nerve damage, acute lung injury | RESPIRATORY DISEASE, DYSPHAGIA, PNEUMONIA, COMA, HEART DISEASE, ACUTE RESPIRATORY DISTRESS SYNDROME, CHRONIC LUNG DISEASE | Participants were recruited if they met the following criteria: Glasgow Coma Scale score of more than 8 points, age between 18 and 70 years, American Society of Anesthesiologists (ASA) level ≥ II, mechanical ventilation duration ≥ 2 h, and elective supratentorial craniotomy. Patients were excluded if they met at least ... | PMC10201743 |
Randomization and blinding | Randomization was conducted using computer-generated random numbers sealed in opaque envelopes. Patients were randomly allocated into two groups by the corresponding envelope. Knowing the group task, the anesthesiologist was responsible for the intervention, and the other researchers, blinded to the random allocation, ... | PMC10201743 | ||
Anesthesia | Smokers had quit smoking more than four weeks before surgery. For intravenous induction, sufentanil (0.2–0.3 µg ⋅ kg | PMC10201743 | ||
Ventilation protocol | Volume-controlled mechanical ventilation was provided (Datex Ohmeda S/5 Advance, General Electric Healthcare, Helsinki, Finland). All patients were preoxygenated with a 0.8 FiO | PMC10201743 | ||
Measurements | Pulmonary complications | PULMONARY COMPLICATIONS | The dynamic changes in aeration distribution can be visualized and evaluated by EIT [LUS can be used as a fast and easily available bedside test to evaluate lung areation. A-lines are a single line or multiple lines parallel to the pleural line and occur in normal lungs [To evaluate gas exchange, arterial blood gas was... | PMC10201743 |
Outcomes | SECONDARY | The primary outcome was the GI value immediately after extubation. The secondary outcomes were LUSs, respiratory system compliance, PaO | PMC10201743 | |
Sample size calculation | The sample size was estimated for a previous study. A difference of 0.1 in GI between groups according to a previous study was detected [ | PMC10201743 | ||
Statistical analysis | INTRAOPERATIVE BLEEDING | Categorical variables are reported as the number (proportion) of patients, normally distributed data are presented as the mean and standard deviation (SD), and nonnormally distributed data are presented as the median (IQR [range]). The Kolmogorov–Smirnov test was used to assess the normality of the distribution. For ba... | PMC10201743 | |
Results | postoperative pulmonary complications | Of 57 patients assessed for eligibility, 4 patients did not meet the inclusion criteria, so 53 patients were randomized into two groups and received the intended interventions. One patient was excluded because he returned to the intensive care unit (ICU) with a tracheal tube after the operation in the titration group, ... | PMC10201743 | |
Discussion | ADVERSE EFFECTS, COLLAPSED LUNG, RECRUITMENT | The main findings of this study included the following: (1) compared with a fixed 5 cmHDP is a significant mediator of PPCs. A DP of greater than 16 cmHThe GI directly represents global inhomogeneity in tidal ventilation [In this study, the LUSs were higher in the control group than in the titration group immediately a... | PMC10201743 | |
Conclusions | Driving pressure-guided ventilation during supratentorial craniotomy did not contribute to postoperative homogeneous aeration, but it may lead to improved respiratory compliance and lower lung ultrasonography scores. | PMC10201743 | ||
Acknowledgements | We thank all the patients and the institutions for supporting this study. | PMC10201743 | ||
Authors’ contribution | RH: provided the conception, supervised the study implementation, and critical revision and reviewed the manuscript. FL: contributed to the study design, anesthesia implementation, data collection, and wrote the draft. WZ: provided the conception, performed the study, and analyzed the data. ZZ: participated in the stud... | PMC10201743 | ||
Funding | ZYLX201708 | This study was supported by funding from Clinical Medicine Development of Special Funding Support (ZYLX201708; DFL20180502) and the Beijing Municipal Science & Technology Commission (Z19110700660000). | PMC10201743 | |
Data Availability | The datasets used and analysed during the current study available from the corresponding author on reasonable request. | PMC10201743 |
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