File institutional FIR within six hours of incident of violence against healthcare worker on duty: Union Health Ministry directs hospitals

Amid the massive outrage and nationwide protests over the brutal rape and murder of a Postgraduate doctor in Kolkata R G Kar Medical College and Hospital, the Union Health Ministry has now issued strict directions to the medical institutes and hospitals across the country to file an institutional FIR within six hours of an incident of violence against any healthcare worker on duty.
The Director General of Health Services (DGHS) Dr. Atul Goel shared this Office Memorandum with the directors and medical superintendents of central government hospitals, including AIIMS, and the directors/principals of all medical colleges across the country.
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Nasal spray flu vaccine candidate shows promise when administered alongside high dose annual shot, finds research

A unique influenza vaccine candidate that’s inhaled and based on technology developed by University of Wisconsin–Madison researchers is safe and could bolster protection against seasonal and pandemic influenza for people vulnerable to severe disease when they receive it in addition to the annual flu shot.

Those are the results of a randomized, controlled trial of the vaccine candidate, administered in nasal spray form in conjunction with the annual shot to a group of 65- to 85-year-olds in 2022. The findings were recently reported in the journal Lancet Infectious Diseases. Here are the details:

A different kind of influenza vaccine

The vaccine candidate tested in this study, FluGen’s M2SR, is based on technology developed by UW–Madison researchers Yoshihiro Kawaoka and Gabriele Neumann more than a decade ago. It differs in a few ways from seasonal flu shots, which for decades have provided suboptimal protection against severe disease for vulnerable people:

  • Typical flu vaccines use inactivated influenza virus administered via a shot in muscle tissue, prompting the immune system to create antibodies that can recognize and combat the virus.
  • The candidate vaccine M2SR relies instead on live virus with an essential replication gene deleted from its DNA. The vaccine is administered directly into the upper respiratory system with a nasal spray.
  • The gene deletion means “it can’t continue replicating and make you sick, but it stimulates the immune system just like a natural virus infection,” says Pamuk Bilsel, who led the study as chief scientific officer for FluGen, a spinoff company founded by Kawaoka, Neumann and FluGen CEO Paul Radspinner.

A safety study with promising results

In 2022, FluGen tested the vaccine candidate among more than 300 people in the United States between the ages of 65 and 85, assessing its safety and the immune response it elicited.

  • Some participants received only the annual flu shot formulated for people in this high-risk age group, while others received only the nasal spray candidate vaccine. A third group received both, and a fourth group received the regular shot and a nasal spray placebo.
  • Participants who received the nasal spray vaccine candidate tolerated it well, with a minority reporting minor side effects including runny nose and nasal congestion.
  • Blood and nasal swab samples taken one day and again 2-4 weeks following vaccination showed that participants who received both the nasal spray vaccine and flu shot had significantly more protective antibodies along with other protective immune responses not seen in participants who received the flu shot alone.
  • Those participants “got not just the antibodies that those normal flu shots give you, but also the local immunity, mucosal immunity and T-cell immunity,” says Bilsel. “It’s a multifaceted, broad spectrum response.”

Better protection against annual influenza and possibly pandemics

While the study was focused on assessing the vaccine candidate’s safety, data on the immune responses it elicited suggests that vulnerable seniors would be better protected from influenza if they receive both the flu shot and nasal spray vaccine.

  • A more protective immune response possibly offered by administering both vaccines could apply to both seasonal influenza and potential pandemic strains since current vaccines are the first line of defense should a strain like the currently circulating H5N1 avian influenza become widely transmissible in humans.
  • While the vaccine candidate shows promise, larger studies are planned to confirm that it’s safe and provides protection. Those studies will take a couple years to complete.

“Older adults deserve better alternatives to prevent infection, illness and hospitalization from influenza and finally we believe we have one,” says Radspinner. “We hope existing manufacturers agree and will be working with them to find ways to make this a reality for patients sooner rather than later.”

Reference:

Joseph Eiden, Carlos Fierro, Alexander White, Matthew Davis, Margaret Rhee, Mark Turner, Safety and immunogenicity of the intranasal H3N2 M2-deficient single-replication influenza vaccine alone or coadministered with an inactivated influenza vaccine (Fluzone High-Dose Quadrivalent) in adults aged 65–85 years in the USA: a multicentre, randomised, double-blind, double-dummy, phase 1b trial, The Lancet Infectious Diseases, https://doi.org/10.1016/S1473-3099(24)00351-7.

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Breakthrough combo therapy for type 1 diabetes: SGLT2 inhibitors + GRAs boost control, cut insulin use, study reveals

USA: In a significant development for treating Type 1 diabetes (T1D), researchers have conducted a randomized clinical trial testing a combination therapy involving SGLT2 inhibitors and glucagon receptor antagonists. This innovative approach aims to improve blood sugar management and potentially reduce the risk of complications associated with the disease.

The study, published in Diabetes Care, revealed that sodium-glucose cotransporter 2 (SGLT2) inhibitors plus glucagon receptor antagonists (GRAs) may reduce insulin use, improve glycemic control, and mitigate ketogenesis risk compared with SGLT2 inhibitors alone in patients with type 1 diabetes.

The researchers revealed that glucagon antagonism enhances the therapeutic effects of SGLT2 inhibition in T1D.

SGLT2 inhibitors are commonly used to treat Type 2 diabetes by blocking glucose reabsorption in the kidneys, thereby promoting excretion through urine. On the other hand, glucagon receptor antagonists work by blocking the action of glucagon, a hormone that raises blood sugar levels, thereby reducing the overall blood glucose levels.

Jeremy H. Pettus, University of California, San Diego, La Jolla, CA, and colleagues aimed to examine the effects of insulin-adjunctive therapy with an SGLT2 inhibitor and a GRA on glycemia, insulin use and ketogenesis during insulinopenia in type 1 diabetes.

For this purpose, the researchers conducted a randomized, double-blind, placebo-controlled, crossover trial to assess the effects of adjunctive SGLT2 inhibitor therapy (dapagliflozin 10 mg daily) alone and in combination with the GRA volagidemab (70 mg weekly) in 12 adults with type 1 diabetes.

Continuous glucose monitoring, insulin withdrawal tests (IWT), and insulin dosing for measurement of ketogenesis and glucose during insulinopenia were completed during SGLT2 inhibitor, insulin-only (Baseline), and combination (SGLT2 inhibitor + GRA) therapy periods.

The study led to the following findings:

  • Average glucose and percent time with glucose in range (70–180 mg/dL) improved with combination therapy versus Baseline and SGLT2 inhibitor (131 versus 150 and 138 mg/dL and 86% vs. 70% and 78%, respectively) without increased hypoglycemia.
  • Total daily insulin use decreased with combination therapy versus Baseline and SGLT2 inhibitor (0.41 versus 0.56 and 0.52 units/kg/day).
  • Peak β-hydroxybutyrate levels during IWT were lower with combination therapy than with SGLT2 inhibitor (2.0 versus 2.4 mmol/L) and similar to levels reached during the Baseline testing period (2.1 mmol/L).
  • Participants reported enhanced treatment acceptability and satisfaction with combination therapy.

“These outcomes underscore the critical role of glucagon in T1D metabolism and the potential of blocking glucagon action, which could facilitate the safe use of SGLT2 inhibitors,” the authors wrote.

In conclusion, combination SGLT2 inhibitor + GRA is a promising adjunctive therapy strategy for type 1 diabetes.

Reference:

Schafer C. Boeder, Robert L. Thomas, Melissa J. Le Roux, Erin R. Giovannetti, Justin M. Gregory, Jeremy H. Pettus; Combination SGLT2 Inhibitor and Glucagon Receptor Antagonist Therapy in Type 1 Diabetes: A Randomized Clinical Trial. Diabetes Care 2024; dc240212. https://doi.org/10.2337/dc24-0212

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Chronic noise exposure of more than 85 decibels associated with overall increase of BP, suggests study

Noise exposure is a known occupational hazard in some jobs, particularly for hearing loss, physical and psychological stress, and reduced concentration. A new study presented at the ACC Asia 2024 conference found in adult power loom weavers, chronic noise exposure not only increased their blood pressure overall, but also each year of exposure increased their odds of having high blood pressure by 10%.

“While the mechanism is still not well-explored, it is thought that the stress response by the body to chronic sound exposure causes hormonal imbalances that gradually leads to a permanent elevation of blood pressure,” said Golam Dastageer Prince, MBBS, MPH, medical officer at DGHS Bangladesh and the study’s lead author. “High blood pressure impacts more than a billion people worldwide and just 1 in 5 have it under control, yet it is a major cause of premature death. In addition to treating the high blood pressure through appropriate means, we must find ways to mitigate the exposure to the noise if we want to reduce the cardiovascular risk of these patients.”

Researchers at the Directorate of General Health Services in Bangladesh looked at 289 adult workers in selected weaving factories in the Araihazar sub-district of Narayanganj, Bangladesh, from January to December 2023. Participants took a face-to-face interview to complete a questionnaire covering sociodemographic variables, behavior, dietary habits and family medical history. Blood pressure, height, weight and noise intensity were measured following standard procedures by the researchers.

The study cohort was predominantly male and married and were about 34 years of age on average. According to the researchers, a notable proportion of the cohort was illiterate. Workplace exposure duration averaged nearly 16 years, with noise intensity ranging from 96-111 decibels. In the United States the National Institute for Occupational Safety and Health has established the recommended exposure limits for occupational noise exposures to be 85 decibels on average over an eight-hour workday. Sounds at or below 70 decibels are generally considered safe.

According to Prince, none of the study population was found to be wearing ear protection personal protective equipment.

“Hopefully we can raise awareness of not only noise-induced hearing loss, but the impact of noise on blood pressure and workers’ behaviors and attitudes towards using personal protective equipment,” Prince said. “Pushing for structural improvements to industries may also help us improve the health safety of these workers.”

The study population had a 31.5% rate of high blood pressure with an additional 53.3% being prehypertensive. The study also found a positive correlation between blood pressure and noise exposure duration. Each year of exposure was found to increase high blood pressure odds by 10%, even after adjusting for age, body mass index and smoking status.

“As the study focused on workers exposed to more than 85 decibels noise for long periods of time, any profession causing workers to experience similar exposure might experience similar blood pressure impacts,” Prince said. “We definitely need more exploratory studies to reveal more information about the potential mechanisms and long-term health outcomes.”

Recent studies have shown that living near noise pollution, including highways, trains and air traffic, can have an impact on cardiovascular health. However, the current study may not apply to noise experienced during daily life. Noise pollution experienced near home typically ebbs and flows, while the industrial exposures in the study are typically continuous in pattern due to the machinery and remain at a constant sound level, according to Prince.

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Study Challenges Notions on Pregnancy Weight Gain in Women with Obesity

USA: In a thought-provoking twist to conventional wisdom, a recent population-based cohort study has challenged long-held beliefs regarding pregnancy weight gain in women with obesity. Published in the prestigious journal The Lancet, the study delves into the safety implications of low weight gain or even weight loss during pregnancy for women across different obesity classes.

The study supports calls to lower or remove the lower limit of current US Institute of Medicine (IOM) recommendations for pregnant women with obesity and suggests warranting separate guidelines for class 3 obesity.

“Gaining less weight than is recommended was associated with better outcomes among those with prepregnancy BMIs >40 kg/m2,” the researchers reported.

There are concerns that current gestational weight gain recommendations for obese women are too high and that guidelines should differ based on the severity of obesity. In the study, Kari Johansson, Karolinska Institutet, Stockholm, Sweden, and colleagues investigated the safety of gestational weight gain below current recommendations or weight loss in pregnancies with obesity. They evaluated whether there is a need for separate guidelines for different obesity classes.

In the population-based cohort study, the researchers used electronic medical records from the Stockholm–Gotland Perinatal Cohort study to identify pregnancies with obesity (early pregnancy BMI before 14 weeks’ gestation ≥30 kg/m2) among singleton pregnancies with deliveries between 2008 and 2015. The pregnancy records were linked with Swedish national healthcare register data up to 2019. Gestational weight gain was calculated as the last measured weight before or at delivery minus early pregnancy weight (at <14 weeks gestation), standardized for gestational age into z-scores.

Poisson regression assessed the association of gestational weight gain z-score with a composite outcome of infant death, stillbirth, small for gestational age and large for gestational age at birth, unplanned cesarean delivery, preterm birth, pre-eclampsia, gestational diabetes, and excess postpartum weight retention, and new-onset longer-term maternal cardiometabolic disease following pregnancy, weighted to account for event severity.

Rate ratios (RRs) were calculated for composite adverse outcomes along the weight gain z-score continuum, compared with a reference of the current lower limit for gestational weight gain recommended by the US IOM (5 kg at term).

The study revealed the following findings:

· The cohort comprised 15 760 pregnancies with obesity, followed up for a median of 7·9 years.

· 74·0% of pregnancies had class 1 obesity, 20·1% had class 2 obesity, and 5·9% had class 3 obesity. Among these pregnancies, 13·9%, 24·9%, and 33·2%, respectively, had weight gain during pregnancy below the lower limit of the IOM recommendation (5 kg).

· In pregnancies with class 1 or 2 obesity, gestational weight gain values below the lower limit of the IOM recommendation or weight loss did not increase the risk of the adverse composite outcome (e.g., at weight gain z-score –2·4, corresponding to 0 kg at 40 weeks: adjusted RR 0·97 in obesity class 1 and 0·96 in obesity class 2).

· In pregnancies with class 3 obesity, weight gain values below the IOM limit or weight loss were associated with reduced risk of the adverse composite outcome (e.g., adjusted RR 0·81 at weight gain z-score –2·4, or 0 kg).

These results challenge guidelines on weight gain in pregnancy. Particularly for women with class 3 obesity, the findings support minimizing pregnancy weight gain — as long as nutritional balance is maintained.

“Careful counseling on healthy pregnancy nutrition at prenatal visits, considering referral for enhanced supports for those with obesity, and addressing barriers to access healthful food might help optimize outcomes for pregnancies affected by obesity,” the researchers concluded.

Reference:

Johansson K, Bodnar LM, Stephansson O, Abrams B, Hutcheon JA. Safety of low weight gain or weight loss in pregnancies with class 1, 2, and 3 obesity: a population-based cohort study. Lancet. 2024 Apr 13;403(10435):1472-1481. doi: 10.1016/S0140-6736(24)00255-1. Epub 2024 Mar 28. PMID: 38555927; PMCID: PMC11097195.

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Higher Resting Heart Rate Linked to Increased Mortality in Non-Dialysis-Dependent CKD Patients: Study Reveals

Japan: A study published in Scientific Reports found that an elevated heart rate is linked to a heightened mortality risk and cardiovascular events in patients with non-dialysis-dependent CKD. 

An increased heart rate is acknowledged as an independent risk factor for all-cause mortality and cardiovascular events in the general population. However, the link between elevated heart rate and adverse clinical outcomes in patients with non-dialysis-dependent chronic kidney disease (CKD) has not been thoroughly explored.

In this study, 1,353 participants from the Fukushima CKD Cohort Study, conducted by Hirotaka Saito and colleagues from the Department of Nephrology and Hypertension at Fukushima Medical University, were analyzed to examine the relationship between resting heart rate and clinical adverse outcomes using Cox proportional hazards analysis.

The key findings of the study are as follows:

  • A higher resting heart rate in patients with non-dialysis-dependent CKD was associated with an increased risk of all-cause mortality.
  • Participants with a resting heart rate of 80-89/min had a 1.74 times higher risk of mortality compared to those with a heart rate below 70/min.
  • Those with a heart rate of 90/min or higher had a 2.61 times higher risk of mortality compared to the reference group.
  • The group with a heart rate of 80-89/min also showed a significantly higher risk of cardiovascular events.
  • However, the increased risk of cardiovascular events was not statistically significant in the group with a heart rate of 90/min or higher.

In summary, the findings of this study indicated that a higher resting heart rate is linked to all-cause mortality and cardiovascular events in patients with non-dialysis-dependent CKD. Future interventional studies are needed to determine whether lowering heart rate in CKD patients could improve clinical outcomes. It is important to recognize that, although various studies have observed associations between elevated heart rate and adverse clinical outcomes, the relationship between heart rate and mortality is complex. Age, comorbidities, and overall cardiovascular health significantly influence an individual’s risk profile. Therefore, heart rate management should be personalized, with treatment decisions based on a comprehensive patient’s overall health evaluation.

Reference

Saito, H., Tanaka, K., Ejiri, H. et al. Elevated resting heart rate is associated with mortality in patients with chronic kidney disease. Sci Rep 14, 17372 (2024). https://doi.org/10.1038/s41598-024-67970-2

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Presurgical Dysregulation of plasma proteins may predict persistent pelvic pain after surgery for endometriosis among adolescents: Study

Researchers in a recent study have demonstrated that specific plasma proteins can actually forecast the persistence of pelvic pain after laparoscopic surgery in young adults and adolescents with endometriosis. The finding reflects how this is related to personalized treatment approaches and potential biological pathways involved in endometriosis-associated pain. This discovery was from a prospective analysis using a multiplex aptamer-based proteomics biomarker discovery platform that was published in the American Journal of Obstetrics and Gynecology by Naoko Sasamoto and colleagues.

The objective of this study was to identify, in plasma proteins, potential markers for the persistence of pelvic pain after laparoscopic surgery in young patients with endometriosis using a state-of-the-art proteomics platform.

Prospective cohort study of 142 women with laparoscopically confirmed endometriosis enrolled in the prospective cohort study Women’s Health Study: From Adolescence to Adulthood between 2012 and through the end of 2018 with prospectively collected and banked biological specimens and patient data using harmonized tools. They measured 1,305 plasma protein levels of banked pre surgical blood from women scheduled for laparoscopic ablation or excision of endometriosis. Worsening or persistent postsurgical pelvic pain was defined by new or stable pain severity, frequency, or life interference of dysmenorrhea or acyclic pelvic pain at one year post surgery.

In this research, individuals of 20 years and above with a new diagnosis in proteinuria in 2009 were recruited. Patients who had previous cranial nerve palsy, incomplete data, diagnosed with a new CNP, or who died within a year after examination were excluded. The subjects in this research were divided into six groups based on urine dipstick test results. In the study, Cox proportional hazard regression analysis was applied to identify the association between proteinuria and ocular motor CNP.

  • The median age at blood draw was 17 years (IQR, 15-19), and 90% were White.

  • All had superficial peritoneal lesions treated by excision or ablation. One year post surgery, 54% of participants experienced worsening or persistent pelvic pain, while 46% reported improvement.

  • Researchers identified 83 proteins associated with worsening or persistent pain (nominal P<.05).

  • Higher presurgical plasma levels of CD63 antigen (OR, 2.98; 95% CI, 1.44-6.19) and CD47 (OR, 2.68; 95% CI, 1.28-5.61) were linked to persistent pain.

  • Lower levels of Sonic Hedgehog protein (OR, 0.55; 95% CI, 0.36-0.84) were observed in those with persistent pain.

  • Pathways related to cell migration were up-regulated, while angiogenesis pathways were down-regulated in participants with worsening pain.

  • An increase in Sonic Hedgehog protein levels from pre surgery to postsurgery was associated with a 4-fold increase in the risk of persistent pain (OR [quartile 4 vs 1], 3.86; 95% CI, 1.04-14.33).

The research findings indicate that plasma proteins can be investigated as biomarkers predicting surgical outcomes in patients with endometriosis. It would actually stratify risk and individualised treatments, hence pain management and improved quality of life to the young women suffering from the condition.

An aptamer-based proteomics platform identified plasma proteins and pathways related to persistent pelvic pain following surgical management of endometriosis. Such biomarkers may offer an assist in risk stratification and particularised treatment strategies for adolescents and young adults with endometriosis.

Reference:

Sasamoto, N., Ngo, L., Vitonis, A. F., Dillon, S. T., Prasad, P., Laufer, M. R., As-Sanie, S., Schrepf, A., Missmer, S. A., Libermann, T. A., & Terry, K. L. (2024). Plasma proteins and persistent postsurgical pelvic pain among adolescents and young adults with endometriosis. American Journal of Obstetrics and Gynecology, 231(2), 240.e1-240.e11. https://doi.org/10.1016/j.ajog.2024.03.005

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Gestational carriers face higher health risks during pregnancy compared to IVF and natural conceptions, new study shows

Gestational carriers, also known as surrogates, experience an elevated risk of severe maternal morbidity and adverse pregnancy outcomes compared to women who conceive naturally or through in vitro fertilisation (IVF), according to new research presented today at the ESHRE 40th Annual Meeting in Amsterdam .

The population-based study analysed 937,938 singleton births in Ontario, Canada between 2012 and 2021, comparing outcomes among unassisted conceptions, IVF conceptions and gestational carriers.

The findings uncovered marked variations in outcomes across the different conception methods. Gestational carriers faced a severe maternal morbidity rate of 7.1%, notably higher than the rates observed in unassisted conceptions (2.4%) and IVF conceptions (4.6%).

Specifically, gestational carriers experienced elevated rates of postpartum haemorrhages and hypertensive disorders, both serious complications during pregnancy. Among gestational carriers, rates of postpartum haemorrhages were 13.9%, compared to 5.7% in unassisted conceptions and 10.5% in IVF conceptions. Similarly, hypertensive disorders, the most common medical problem encountered during pregnancy, affected gestational carriers at a rate of 13.9%, compared to 6.6% in unassisted conceptions and 11.6% in IVF conceptions.

Marina Ivanova, study author from Queen’s University in Kingston, Canada, comments, “There are several potential mechanisms that might explain the increased risk of severe maternal morbidity among gestational carriers. These include differences in baseline health or sociodemographic characteristics of those who choose to become gestational carriers, potential differences in prenatal care and monitoring, the physiological and psychological impact associated with carrying a pregnancy for another person, as well as the effects of the treatments used during the IVF process.”

“While some literature proposes that gestational carriers are carefully chosen based on favourable characteristics for a healthy pregnancy, our cohort did not consistently reflect this idea”, furthers Dr Maria Velez, study supervisor and senior author. “Gestational carriers were also less likely to be in the highest income bracket, and we know that lower socioeconomic status is associated with higher serious maternal morbidity rates. However, sociodemographic characteristics were accounted for in the analysis, and the results were similar, which suggest potential different mechanisms.”

A gestational carrier is defined as a woman who bears a genetically unrelated child for another person or couple . Typically, IVF is used to fertilise the intended parent’s egg, and the resulting embryo is placed in the gestational carrier’s uterus.

Since the introduction of this method, the use of gestational carriers has been on the rise due to a number of factors, including increasing levels of infertility, a growing number of male same-sex couples seeking to have children, greater social acceptance of different family forms, advancements in medical technology and an increase in fertility clinics worldwide.

Despite the elevated risk of severe maternal morbidity and adverse pregnancy outcomes, the study did not find any significant difference in health outcomes for babies up to 28 days old between gestational carriers, unassisted conceptions, and IVF conceptions. Serious health problems were present in 6.5%, 6%, and 9.1% of neonates, respectively.

Marina Ivanova explains, “Even with the increased risk of severe maternal morbidity among gestational carriers, we were surprised to find no significant increase in severe neonatal morbidity compared to unassisted conceptions. While gestational carriers experience more complications, these do not necessarily lead to worse outcomes for the newborns, which is a positive finding.

In contrast, among women from the general population, severe maternal morbidity is associated with a higher risk of severe neonatal morbidity. This difference therefore warrants further investigation.”

Professor Dr Karen Sermon, Chair of ESHRE, explains, “These results highlight the impact of socioeconomic status on our reproductive health, and the need to surround candidate gestational carriers with the best standard of care. It is reassuring-and also intriguing-that children born to gestational carriers do not seem to be impacted by the higher pregnancy risks.”

Reference:

Gestational carriers face higher health risks during pregnancy compared to IVF and natural conceptions, new study shows, European Society of Human Reproduction and Embryology, Meeting: ESHRE 40th Annual Meeting.

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Mpox outbreak in Africa was neglected—it could now turn into the next global pandemic

The mpox outbreak in Africa is yet another example of how infectious diseases perceived to be “someone else’s problem,” and affecting mainly poor, developing countries, may suddenly pose unexpected global threats.

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