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Alan Kivitz,1 Alicia M Ellis,2 Vishvesh Shende,3 Jérémy Lambert,4 Daljit Tatla2 1Altoona Center for Clinical Research, Duncansville, PA, USA; 2UCB Pharma, Raleigh, NC, USA; 3UCB Pharma, Slough, UK; 4UCB Pharma, Colombes, FranceCorrespondence: Daljit Tatla, UCB Pharma, 4000 Paramount Parkway, Morrisville, NC, USA, Tel +1 919 767-2518, Email daljit.tatla@ucb.comPurpose: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, key drivers of chronic inflammation. Bimekizumab must be injected subcutaneously and so patients require self-injection options that meet their preferences. This study evaluated safe and effective self-injection of bimekizumab by patients with psoriatic arthritis using the 1 mL safety syringe (SSy) or the 1 mL auto-injector (AI).Patients and Methods: The DV0004 devices study (NCT04109976) was a sub-study of BE VITAL, a multicenter, open-label extension of BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581) in patients with active psoriatic arthritis. After receiving training, patients subcutaneously self-injected bimekizumab 160 mg at Baseline and Week 4. The primary and secondary endpoints were the proportion of patients self-injecting bimekizumab safely and effectively at Week 4 and Baseline, respectively. Patient self-injection experience was evaluated using the pain visual analog scale (VAS) and the Self-Injection Assessment Questionnaire (SIAQ).Results: Overall, 214 patients were randomized 1:1 at Baseline. All evaluable patients safely and effectively self-injected bimekizumab at Week 4 (SSy: n=105; AI: n=104) and Baseline (SSy: n=106; AI: n=106). Mean pain VAS scores were generally low at Week 4 (SSy: 11.0; AI: 11.4) and Baseline (SSy: 9.5; AI: 14.9). High mean pre- and post-injection SIAQ scores (≥ 6.7) were observed for both devices indicating a positive overall patient experience with self-injection. Self-injection was well tolerated with no reports of treatment-emergent adverse device effects (TEADEs), serious TEADEs or discontinuations due to TEADEs. Four non-device-related injection site reactions during the sub-study were reported in the parent study; all were mild, did not lead to discontinuation and resolved without treatment. All devices maintained their structural and functional integrity post-use.Conclusion: All patients self-injected subcutaneous bimekizumab safely and effectively using either device at Baseline and Week 4. Overall, patients reported a positive self-injection experience.Keywords: bimekizumab, clinical trial, patient experience, psoriatic arthritis, self-injection devices

Many interesting spaces-including all positroid strata and wild character varieties- are moduli of constructible sheaves on a surface with microsupport in a Legendrian link. We show that the existence of cluster structures on these spaces may be deduced in a uniform, systematic fashion by constructing and taking the sheaf quantizations of a set of exact Lagrangian fillings in correspondence with isotopy representatives whose front projections have crossings with alternating orientations. It follows in turn that results in cluster algebra may be used to construct and distinguish exact Lagrangian fillings of Legendrian links in the standard contact three space.

We conjecture an expression for the dimensions of the Khovanov-Rozansky HOMFLY homology groups of the link of a plane curve singularity in terms of the weight polynomials of Hilbert schemes of points scheme-theoretically supported on the singularity. The conjecture specializes to our previous conjecture (2012) relating the HOMFLY polynomial to the Euler numbers of the same spaces upon setting t=-1. By generalizing results of Piontkowski on the structure of compactified Jacobians to the case of Hilbert schemes of points, we give an explicit prediction of the HOMFLY homology of a (k,n) torus knot as a certain sum over diagrams. The Hilbert scheme series corresponding to the summand of the HOMFLY homology with minimal “a” grading can be recovered from the perverse filtration on the cohomology of the compactified Jacobian. In the case of (k,n) torus knots, this space furnishes the unique finite-dimensional simple representation of the rational spherical Cherednik algebra with central character k/n. Up to a conjectural identification of the perverse filtration with a previously introduced filtration, the work of Haiman and Gordon and Stafford gives formulas for the Hilbert scheme series when k=mn+1.

Chrysomya megacephala (Diptera: Calliphoridae) also known as oriental latrine fly is blow fly species widely distributed in many parts of the world. This y has forensic importance as it infests on carrion soon after death and helps not only to estimate the post-mortem interval (PMI) but also to detect poisoning in a putrefying body. The present study was carried out on morphological identification of Chrysomya megacephala using key Lutz, 2018 and Cytochrome C Oxidase (COI). The special attention was focused on the tertiary morphological characteristics of flies collected from Nagpur region. The new COI subunit I (588 bp) gene sequence of Chrysomya megacephala have been added to GenBank (Accession No.- MN082633). [ABSTRACT FROM AUTHOR]

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy seen in uremic patients. The study was undertaken to estimate the frequency of CTS in uremic patients and to identify the most sensitive electrodiagnostic test. Study was conducted on 80 subjects of age 30-60 years. End‑stage kidney disease patients were recruited for the clinical evaluation, motor nerve conduction studies (NCS), sensory NCS, F wave study and median‑versus‑ulnar comparison studies (palm‑to‑wrist mixed comparison study, digit 4 sensory latencies study and lumbrical‑interossei comparison study). Among three different diagnostic modalities, frequency of CTS was found to be 17.5% with clinical evaluation, 15% with routine NCS studies and 25% with median‑versus‑ulnar comparison studies. Among the median‑versus‑ulnar comparison studies, lumbrical‑interossei comparison study was found to be most sensitive (90%). The comparative tests for CTS are more sensitive compared to routine NCS and clinical examination. Among the comparative tests, lumbrical‑interossei comparison study is the most sensitive. Early diagnosis of CTS may help patients of uremia to seek proper treatment at an appropriate time. [ABSTRACT FROM AUTHOR]

Geographical information system (GIS)-based noise simulation software (N-GNOIS) has been developed to simulate the noise scenario due to point and mobile sources considering the impact of geographical features and meteorological parameters. These have been addressed in the software through attenuation modules of atmosphere, vegetation and barrier. N-GNOIS is a user friendly, platform-independent and open geospatial consortia (OGC) compliant software. It has been developed using open source technology (QGIS) and open source language (Python). N-GNOIS has unique features like cumulative impact of point and mobile sources, building structure and honking due to traffic. Honking is the most common phenomenon in developing countries and is frequently observed on any type of roads. N-GNOIS also helps in designing physical barrier and vegetation cover to check the propagation of noise and acts as a decision making tool for planning and management of noise component in environmental impact assessment (EIA) studies. [ABSTRACT FROM AUTHOR]

Introduction: Psoriatic arthritis (PsA) is a chronic inflammatory disease requiring long-term treatment. Bimekizumab, a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A, has demonstrated tolerability and sustained clinical efficacy for up to 1 year for patients with PsA. Here, we report the longer-‍term safety and efficacy of bimekizumab up to 2 years., Methods: BE OPTIMAL (biologic disease-modifying antirheumatic drug [bDMARD]-naïve) and BE COMPLETE (prior inadequate response/intolerance to tumor necrosis factor inhibitors [TNFi-IR]) assessed subcutaneous bimekizumab 160 mg every 4 weeks in patients with PsA. BE OPTIMAL included a reference arm (adalimumab 40 mg every 2 weeks); patients switched to bimekizumab at week 52 with no washout between treatments. BE OPTIMAL week 52 and BE COMPLETE week 16 completers were eligible for the BE VITAL open-label extension. Efficacy outcomes are reported to week 104/100 (BE OPTIMAL/BE COMPLETE)., Results: A total of 710/852 (83.3%) bDMARD-naïve and 322/400 (80.5%) TNFi-IR patients completed week 104/100. Up to 104 weeks, patients treated with bimekizumab in BE OPTIMAL and BE COMPLETE had treatment-emergent adverse event incidence rates (exposure-adjusted incidence rate/100 patient-years) of 179.9 (95% CI 166.9, 193.7) and 100.3 (89.2, ‍112.4), respectively. The proportion of patients achieving efficacy outcomes (≥ 50% improvement from baseline in American College of Rheumatology [ACR] response criteria, 100% improvement from baseline in Psorisis Area and Severity Index [PASI], minimal disease activity [MDA]) was sustained in all patients from week 52 to week 104/100., Conclusions: Bimekizumab was well tolerated for up to 2 years of treatment and no new safety signals were observed. Sustained clinical efficacy was observed up to 2 years in bDMARD-naïve and TNFi-IR patients with active PsA. Patients switching from adalimumab to bimekizumab demonstrated further improvement in skin and nail symptoms, and sustained efficacy in joint symptoms., Trial Registration: BE OPTIMAL (NCT03895203), BE COMPLETE (NCT03896581), BE VITAL (NCT04009499)., (© 2024. The Author(s).)

Purpose: Radiotherapy (RT) relies on devices like thermoplastic masks (TMs), that are made up of specialized thermoplastic polymers, and used as an immobilization tool. The study aims to assess the practice of usage and reuse of TMs among radiation therapy technologists (RTTs) in India and explore their awareness of environmental impact during disposal., Materials and Methods: A cross-sectional survey was conducted among RTTs working in different healthcare settings. A structured questionnaire designed by a team of RTTs and radiation oncologists was used to collect responses. Questionnaire encompassed data pertaining to demographics, existing patient load, daily utilisation and reuse practice of TMs, preferred method of disposal and awareness of RTTs regarding environmental consequences associated with TM disposal., Results: A total of 430 RTTs participated in the study, with a median age of 31 years and a median professional experience of 8 years. Among the participants, 213 (49.6 %) reported daily TM utilization in more than 50 patients. TM reuse was reported by 350 (81.1 %) RTTs, with 257 (60 %) reusing TMs in both curative and palliative treatments. Reuse of TMs was observed more commonly in RTTs working in government facilities (81.2 %).Regarding disposal preferences, 381 (88.6%) participants preferred discarding used TMs in biomedical waste and 64.8% of these ultimately ended up as discarded scrap. Awareness regarding adverse environmental impact associated with TM disposal was reported by 320 (74.4%) participant RTTs., Conclusion: The study highlights the prevalent practice of reuse of TMs, especially in curative treatments, government-run facilities and busy treatment settings. Additionally, it emphasises the imperative for enhanced bio-medical waste management practices to facilitate more effective handling and disposal of used TMs., Competing Interests: 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., (© 2024 Published by Elsevier B.V. on behalf of European Society for Radiotherapy & Oncology.)

Clinicians, researchers in health services, and other experts have been investigating how to improve healthcare using advanced computer and telecommunication technology for more than 30 years. Adequate medical facilities are still lacking in many places of the world. In these kinds of situations, technology can be quite helpful in expanding healthcare access to rural locations and offering better care at a lower cost. The delivery of healthcare is changing dramatically because of telemedicine and telehealth, particularly in terms of improving access to care. This paper aims to provide an update on the history, background, applications, benefits, barriers, and challenges of these recent technologies. This review article also covers the healthcare conditions of rural as well as urban communities. Furthermore, the implications of technologies used and improvement in the health status of an individual are also discussed. During the COVID-19 epidemic, telehealth quickly gained popularity, bringing to light a number of issues. Effective primary medical networks are crucial, as the COVID-19 pandemic highlighted the need for improving public health responses during crises and revealed the existing fragmentation in healthcare delivery systems., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Shende et al.)

Objectives: To assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to tumour necrosis factor inhibitors., Methods: Patients completing the 16-week phase III double-blind, placebo-controlled BE COMPLETE (NCT03896581) study entered the open-label extension, BE VITAL (NCT04009499). All patients in BE VITAL received 160 mg bimekizumab every 4 weeks. Safety and efficacy are reported to week 52., Results: A total of 347/400 (86.8%) patients completed week 52. To week 52, the exposure-adjusted incidence rate/100 patient-years for ≥1 treatment-emergent adverse event (TEAE) was 126.0, and was 7.0 for serious TEAEs. The most frequent TEAEs were SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis and urinary tract infection. All fungal infections were mild or moderate in severity and localised; two patients discontinued the study due to oral candidiasis. No cases of active tuberculosis, uveitis or inflammatory bowel disease were reported. One sudden death occurred. Sustained efficacy was observed with bimekizumab from week 16 to ‍52 across clinical and patient-reported outcomes. At week 52, 51.7% bimekizumab-randomised and 40.6% placebo/bimekizumab patients (receiving bimekizumab from week 16 to 52) had ≥50% improvement in the American College of Rheumatology criteria. Complete skin clearance (Psoriasis Area and Severity Index 100) was achieved by 65.9% bimekizumab and 60.2% placebo/bimekizumab patients at week 52. Minimal disease activity was achieved by 47.2% bimekizumab and 33.1% placebo/bimekizumab patients at week 52., Conclusions: Bimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52., Competing Interests: Competing interests: LCC: Grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma; consultant for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Domain, Eli Lilly, Galapagos, Gilead, Janssen, Moonlake Pharma, Novartis, Pfizer and UCB Pharma; speaking fees from AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, medac, Novartis, Pfizer and UCB Pharma. Associate Editor of RMD Open. RL: Consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, Pfizer, Novartis, and UCB Pharma; owner of Rheumatology Consultancy BV, an AMS company under Dutch law. On the Editorial Board of RMD Open. IBM: Consulting fees and honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Cabaletta, Causeway Therapeutics, Celgene, Eli Lilly, Evelo, Janssen, Moonlake Pharma, Novartis and UCB Pharma; research support from BMS, Boehringer Ingelheim, Celgene, Janssen, Novartis and UCB Pharma. On the Editorial Board of RMD Open. PJM: Research grants from AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma; consultancy fees from AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Moonlake Pharma, Novartis, Pfizer, Sun Pharma and UCB Pharma; speakers’ bureau for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. CTR: Research for AbbVie; consultant for AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma. YT: Speaking fees and/or honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho; received grants from Chugai, Eisai, Mitsubishi-Tanabe and Taisho. On the Editorial Board of RMD Open. AA: Honoraria and/or research grants from AbbVie, Amgen, BMS, Boehringer Ingelheim, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharmaceutical Co. and UCB Pharma. FB: Consultant and/or speaker and/or investigator for AbbVie, Affibody, Amgen, BMS, Boehringer Ingelheim, Celgene, Chugai, Eli Lilly, Genzyme, GSK, Janssen, MoonLake Pharma, MSD, Novartis, Pfizer, Roche, Sandoz and Sanofi. DDG: Consultant and/or received grant support from AbbVie, Amgen, BMS, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB Pharma. LG: Grants from AbbVie, Biogen, Eli Lilly, Novartis, Sandoz and UCB Pharma; personal fees from AbbVie, Amgen, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Sandoz and UCB Pharma. AMO: Research grants to Johns Hopkins University from AbbVie, Amgen, and Janssen; consulting fees from BMS, Janssen, Sanofi and UCB Pharma. ABG: Received research/educational grants from AnaptypsBio, BMS, Highlights Therapeutics, Janssen, Moonlake Immunotherapeutics AG, Novartis and UCB Pharma, (all paid to Mount Sinai School of Medicine); Received honoraria as an advisory board member and consultant for Amgen, AnaptypsBio, Avotres Therapeutics, BMS, Boehringer Ingelheim, Dice Therapeutics, Eli Lilly, Highlights Therapeutics, Janssen, Novartis, Sanofi, UCB and Xbiotech. RBW: Consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi and UCB Pharma; research grants to his institution from AbbVie, Almirall, Janssen, LEO Pharma, Novartis and UCB Pharma; honoraria from Astellas, DICE Therapeutics, GSK and Union Therapeutics. BI: Shareholder of AbbVie, GSK and UCB Pharma; employee of UCB Pharma. RB and JC: Employees and shareholders of UCB Pharma. VS: Employee of UCB Pharma. JFM: Consultant and/or investigator for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Pfizer, Novartis, Regeneron, Sanofi, Sun Pharma and UCB Pharma., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Health insurance literacy gauges how knowledgeable people are regarding the comparison of health insurance plans to find out the optimal health plan that suits their needs and preferences. Enrolling in a comprehensive plan and proactively addressing health and financial aspects can fortify the stability of families. The plan needs to be used effectively by adapting to evolving circumstances and prioritizing the well-being and prosperity of the household. Having public health insurance can significantly impact an individual's utilization of healthcare services. Having health insurance encourages individuals to promptly seek medical attention without hesitating or avoiding treatment due to financial worries. This results in higher utilization of healthcare services, encompassing routine check-ups, preventive care, and timely intervention for illnesses and injuries. Public health insurance can also improve access to specialized care and expensive treatments that may otherwise be unaffordable for individuals without insurance. By having health insurance, individuals and families can experience a decrease in the economic strain associated with healthcare expenses, thereby enhancing the accessibility and affordability of healthcare services., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Shende et al.)

Background: Guillain-Barré syndrome (GBS) is a condition characterized by acute and progressive weakness that impacts the limbs, facial muscles, and bulbar muscles due to acute polyneuro-radiculopathy. Typically, an infection that results in immune-mediated nerve dysfunction is what starts the disease. Patients often encounter paresthesia or discomfort before progressing to muscle weakness, initially in the lower extremities (which may include some proximal components) and subsequently in the upper extremities. The features of polyneuropathy identified during electrophysiology tests, bolstered by evidence of acquired demyelination in the nerve conduction study (NCS), support the clinical diagnosis of GBS. In peripheral neuropathies, NCS often reveals abnormalities in nerve conduction parameters. A specific pattern observed in the sensory nerve conduction study (SNCS), referred to as "sural sparing," signifies that the sural nerve, located near the calf muscles, remains relatively unaffected compared to other sensory nerves. Very few studies have been conducted to investigate improvements in sensory nerve conduction (SNC) parameters before and after intravenous immunoglobulin (IVIG), offering limited clinical correlation for the recovery and prognosis of the disease. The study aimed to observe the NCS parameters of the sensory nerves in both the upper and lower limbs, before and after the infusion of IVIG., Methodology: This study was an observational investigation conducted in the neurophysiology laboratory of the Physiology Department at a rural medical college in central India. Fifty clinically diagnosed cases of GBS aged between 18 and 60 years were referred from the Department of Medicine to the Physiology Department for conducting the NCS. Basic sociodemographic information, along with clinical history, was collected. Subsequently, the RMS EMG EP Mark-II machine was employed to examine the sensory nerve action potentials (SNAPs), such as amplitude (in mV) and conduction velocity (in ms), of the sensory nerves in both the upper and lower limbs before and after IVIG infusion. The IVIG infusion occurs within one week of clinically diagnosing GBS. Following an initial NCS, a second NCS follow-up study was conducted one week after the IVIG infusion to analyze the changing trend in sensory nerves., Results: Upon analysis, no significant correlation was observed between the pre- and post-IVIG SNAPs of the median and ulnar nerves. However, the sural nerve conduction velocity's p-value of 0.033 demonstrated statistical significance, suggesting that the sural nerve is comparatively spared, confirming sural sparing. However, the SNAP of the sensory nerves in GBS patients showed a significant improvement overall, and only NCS quantified the percentage of improvement., Conclusion: According to the study, the NCS of sensory nerves showed a positive change in the parameters examined before and after the infusion of IVIG. This underscores the timely intervention of GBS with IVIG, and conducting the sensory conduction study diligently will enhance knowledge about the recovery period. Additionally, it supports the treating physician in making informed interventions based on the results post-IVIG infusion. This enhancement in the sensory nerves can only be quantified through NCS., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, A et al.)

A comprehensive entomological survey was undertaken in Alipurduar District, West Bengal, from 2018 to 2020 and in 2022. This study was prompted by reported malaria cases and conducted across nine villages, seven Sub-Centres, and three Primary Health Centres (PHCs). Mosquitoes were hand-collected with aspirators and flashlights from human dwellings and cattle sheds during the daytime. Both morphological and molecular techniques were used for species identification. Additionally, mosquitoes were tested for Plasmodium parasites and human blood presence. Mosquito species such as An. barbirostris s.l. , An. hyrcanus s.l. , An. splendidus , and An. vagus were morphologically identified. For species like An. annularis s.l. , An. minimus s.s. , An. culicifacies s.l. , and An. maculatus s.s ., a combination of morphological and molecular techniques was essential. The mitochondrial cytochrome c oxidase gene subunit 1 (CO1) was sequenced for An. annularis s.l. , An. maculatus s.s. , An. culicifacies s.l. , An. vagus , and some damaged samples, revealing the presence of An. pseudowillmori and An. fluviatilis . The major Anopheles species were An. annularis s.l ., An. culicifacies s.l. , and An. maculatus s.s ., especially in Kumargram and Turturi PHCs. Plasmodium positivity was notably high in An. annularis s.l. and An. maculatus s.s. with significant human blood meal positivity across most species. Morphological, molecular, and phylogenetic analyses are crucial, especially for archived samples, to accurately identify the mosquito fauna of a region. Notably, this study confirms the first occurrence of An. pseudowillmori and An. sawadwongporni in West Bengal and implicates An. maculatus s.s ., An. culicifacies s.l. , and An. annularis s.l. as significant vectors in the Alipurduar region.

Objectives: Bimekizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. BKZ treatment has demonstrated superior efficacy versus placebo (PBO) at Week 16 in biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with active psoriatic arthritis (PsA). Here, we report long-term efficacy and safety to Week 52., Methods: BE OPTIMAL comprised a 16-week, double-blind, PBO-controlled period, then 36 weeks treatment-blind. Patients were randomised 3:2:1 to subcutaneous BKZ 160 mg every 4 weeks, PBO with switch to BKZ at Week 16, or reference arm (adalimumab (ADA) 40 mg every 2 weeks). Efficacy outcomes included the American College of Rheumatology (ACR) response criteria 20/50/70, Psoriasis Area and Severity Index (PASI) 75/90/100 in patients with baseline psoriasis affecting ≥3% body surface area and minimal disease activity (MDA); non-responder imputation., Results: ACR20/50/70, PASI75/90/100 and MDA responses were sustained with BKZ to Week 52, consistent with results observed at Week 16. Patients who switched to BKZ at Week 16 demonstrated improvements in efficacy with similar results to BKZ-randomised patients by Week 52.To Week 52, 555/702 (79.1%) patients had ≥1 treatment-emergent adverse event (TEAE) during BKZ treatment; 113/140 (80.7%) on ADA. On BKZ, 46 (6.6%) patients had serious TEAEs. 54 (7.7%) Candida infections occurred during BKZ treatment and 1 (0.7%) during ADA; all cases were localised and non-serious. One death occurred in a BKZ-treated patient, unrelated to treatment., Conclusions: The efficacy of BKZ in bDMARD-naïve patients with PsA was sustained from Week 16 to Week 52. BKZ was well tolerated with no new safety signals observed., Trial Registration Number: NCT03895203., Competing Interests: Competing interests: CTR: research for AbbVie; consultant for Amgen, AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma. LCC: has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma; worked as a paid consultant for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Domain, Eli Lilly, Galapagos, Gilead, Janssen, Moonlake, Novartis, Pfizer and UCB Pharma; and has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB Pharma. IBM: consulting fees and honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Cabaletta, Causeway Therapeutics, Celgene, Eli Lilly, Evelo, Janssen, Moonlake, Novartis and UCB Pharma; research support from BMS, Boehringer Ingelheim, Celgene, Janssen, Novartis and UCB Pharma; Associate Editor at Annals of the Rheumatic Diseases. PJM: research grants from AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma; consultancy fees from AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Moonlake Pharma, Novartis, Pfizer, Sun Pharma and UCB Pharma; speakers’ bureau from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. JFM: consultant and/or investigator for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma and UCB Pharma. YT: speaking fees and/or honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho; received grants from Chugai, Eisai, Mitsubishi-Tanabe and Taisho; Editorial Board Member at Annals of the Rheumatic Diseases. AA: honoraria and/or research grants from AbbVie, Amgen, BMS, Boehringer Ingelheim, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharmaceutical and UCB Pharma. LG: research grants from Sandoz and UCB Pharma; consulting fees from AbbVie, Amgen, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Sandoz and UCB Pharma; Editorial Board Member at Annals of the Rheumatic Diseases. ABG: received honoraria as an advisory board member and consultant for Amgen, AnaptypsBio, Avotres Therapeutics, BMS, Boehringer Ingelheim, Dice Therapeutics, Eli Lilly, Janssen, Novartis, Sanofi, UCB Pharma and Xbiotech; has received research/educational grants from AnaptypsBio, BMS, Moonlake Immunotherapeutics, Novartis and UCB Pharma (all paid to Mount Sinai School of Medicine). RBW: consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi and UCB Pharma; research grants to his institution from AbbVie, Almirall, Janssen, LEO Pharma, Novartis and UCB Pharma; honoraria from Astellas, DiCE, GSK and Union. BI: employee of UCB Pharma and shareholder of AbbVie, GSK and UCB Pharma. RB, VS, JC are all employees and shareholders of UCB Pharma. RL: consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma. Research grants from AbbVie, Novartis, Pfizer and UCB Pharma. Owner of Rheumatology Consultancy BV, an AMS company under Dutch law; Editorial Board Member at Annals of the Rheumatic Diseases., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

This study uses novel evolutionary algorithms and computational techniques to analyze wind potential on flat, complex coastal, and offshore sites utilizing mast as well as remote sensing data. The wind data were recorded using remote sensing technique and conventional technique. The optimum Weibull parameters are estimated using nine methods. The genetic algorithm, particle swarm optimization, and TLBO algorithms are compared and evaluated. The goodness of fit test, such as root mean square error test (RMSE), mean absolute percentage error (MAPE), coefficient of determination (R 2 ), and chi-square test (X 2 ), is used to evaluate the accuracy of the selected methods. Parameter estimates are used to compute wind densities. The TLBO and PSO algorithms outperformed genetic algorithms in terms of efficiency. This research compares remote sensing measurements to cup anemometer measurements., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

The accurate selection of the wind speed distributions is crucial for a better utilisation of wind energy. The Weibull distribution is most commonly used distribution and hence its parameters need to be optimized. In this study five numerical methods, namely, maximum likelihood method (MLM), graphical method (GM), empirical method of Justus (EMJ), modified maximum likelihood method (MMLM) and wind atlas analysis and application program (WAsP) and three metaheuristic optimization algorithms, namely, social spider optimization (SSO), particle swarm optimization (PSO) and genetic algorithm (GA) are applied for estimating Weibull distribution parameters at three different locations (onshore-Kayathar, nearshore-Jafrabad and offshore-Gulf of Khambhat (GOK) in India and also comparison of numerical and optimization methods are employed to tune the optimal parameters. The accuracy of the methods was evaluated using three different statistical analysis techniques. As per the results, GOK has the maximum wind power density of 450.2 W/m 2 compared to Jafrabad and Kayathar. It was observed that among the five methods used for Weibull parameters estimation, WAsP method presented a better curve fit with the histogram of the wind speed. The results shows that SSO and PSO presents a comparably better performance than GA in the term of accuracy on the basis of closeness to converged solution., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F. We assessed the efficacy and safety of bimekizumab in patients with active psoriatic arthritis who were naive to biologic disease-modifying antirheumatic drugs (DMARDs)., Methods: BE OPTIMAL was a 52-week, phase 3, multicentre, randomised, double-blind, placebo-controlled, active reference (adalimumab) trial done at 135 sites (hospitals, clinics, doctors' offices, and research centres) in 14 countries. Eligible patients were 18 years or older with a documented diagnosis of adult-onset psoriatic arthritis that met the Classification Criteria for Psoriatic Arthritis for at least 6 months before screening. Participants were randomly assigned with an interactive-voice and web-response system on the basis of a predetermined randomisation schedule (3:2:1, stratified by region and bone erosion number at baseline) to bimekizumab 160 mg every 4 weeks, placebo every 2 weeks, or the reference group (adalimumab 40 mg every 2 weeks), all administered subcutaneously. At week 16, patients randomly assigned to placebo switched to bimekizumab 160 mg every 4 weeks. The primary endpoint was the proportion of patients reaching 50% or greater improvement in American College of Rheumatology criteria (ACR50) at week 16 (non-responder imputation). Efficacy analyses included all patients who were randomly assigned (intention-to-treat population); the safety analysis set comprised patients who received one or more doses of treatment. Data are presented to week 24 (preplanned analysis). This trial is registered at ClinicalTrials.gov, NCT03895203., Findings: Between April 3, 2019, and Oct 25, 2021, 1163 patients were screened and 852 were randomly assigned to bimekizumab (n=431), placebo (n=281), and reference (adalimumab; n=140) groups. At week 16, significantly more patients receiving bimekizumab (189 [44%] of 431) reached ACR50 response versus placebo (28 [10%] of 281; odds ratio 7·1 [95% CI 4·6-10·9], p<0·0001; adalimumab 64 [46%] of 140). All secondary hierarchical endpoints were met. Treatment-emergent adverse events up to week 16 were reported in 258 [60%] of 431 patients receiving bimekizumab, 139 [49%] of 281 patients receiving placebo, and 83 [59%] of 140 patients receiving adalimumab. No deaths occurred., Interpretation: Bimekizumab treatment had superior improvements in joint, skin, and radiographic efficacy outcomes at week 16 compared with placebo in patients with psoriatic arthritis who were naive to biologic DMARDs. The safety profile of bimekizumab, including the occurrence of fungal infections, was consistent with previous phase 3 studies in patients with plaque psoriasis, and with IL-17A inhibitors., Funding: UCB Pharma., Competing Interests: Declaration of interests IBM reports consulting fees and honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Cabaletta, Causeway Therapeutics, Celgene, Evelo, Janssen, Novartis, Lilly, Moonlake, and UCB Pharma; and research support from BMS, Boehringer Ingelheim, Celgene, Janssen, Novartis, and UCB Pharma. AA reports honoraria or research grants from AbbVie, Amgen, BMS, Boehringer Ingelheim, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharmaceutical, and UCB Pharma. LCC reports grants or research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma; paid consultant work for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Domain, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer, and UCB Pharma; and paid speaker work for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer, and UCB Pharma. RL reports consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly, Novartis, Pfizer, and UCB Pharma; research grants from AbbVie, Novartis, Pfizer, and UCB Pharma; and is an owner of Rheumatology Consultancy, an AMS company under Dutch law. JFM reports consultant or investigator work for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB Pharma. CTR reports research for AbbVie, Amgen, and UCB Pharma; and consultancy for Amgen, AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma. YT reports speaking fees or honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, GSK, Mitsubishi-Tanabe, and Pfizer; and research grants from AbbVie, Asahi-Kasei, Boehringer Ingelheim, Chugai, Daiichi-Sankyo, Eisai, and Takeda. LG reports non-financial support from UCB Pharma, during the conduct of the study; grants from Amgen, Galapagos, Lilly, Pfizer, Sandoz, and UCB Pharma; personal fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, and UCB Pharma; and non-financial support from AbbVie, Janssen, Novartis, Pfizer, and UCB Pharma, outside the submitted work. ABG reports honoraria as an advisory board member, non-promotional speaker, or consultant for Amgen, AnaptysBio, Avotres Therapeutics, BMS, Boehringer Ingelheim, Dermavant, Eli Lilly, Janssen, Novartis, Pfizer, Sanofi, Sun Pharma, UCB Pharma, and Xbiotech (stock options); and research or educational grants from AnaptysBio, BMS, Janssen, Novartis, Ortho Dermatologics, Sun Pharma, and UCB Pharma (all funds go to the Icahn School of Medicine at Mount Sinai). RBW reports consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma; research grants to his institution from AbbVie, Almirall, Janssen, LEO Pharma, Novartis, and UCB Pharma; and honoraria from Astellas, DiCE, GSK, and Union. BI is an employee and stockholder of UCB Pharma and a stockholder of GSK and AbbVie. DA, RB, VS, and JC are all employees and stockholders of UCB Pharma. PJM reports research grants from AbbVie, Amgen, BMS, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun Pharma, and UCB Pharma; consultancy fees from AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Inmagene, Janssen, Moonlake Pharma, Novartis, Pfizer, Sun Pharma, and UCB Pharma; and speakers' bureau fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, and UCB Pharma., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Zinc is an essential micronutrient for numerous catalytic, structural and regulatory functions in human body. However, its direct fortification in the food matrix poses the challenges of decreased bio-accessibility by forming insoluble sediments. Complexing zinc with polysaccharides has been reported as a possible intervention to address this issue by keeping the zinc in soluble form. Present investigation was undertaken to transform paneer whey containing complexed zinc into a sensorially acceptable beverage by varying its pH from 3.5 to 5.5, common salt concentration from 0.5 to 1.5% and spices concentration at 0.2 and 0.4%. Changes in complexed zinc concentration, apparent viscosity, instrumental color parameters and sensory attributes were determined. Complexed zinc concentration increased (p < 0.05) with increasing pH, decreasing salt and increasing spices concentration. Whey beverage having 4.5 pH, 1.0% salt and 0.4% spices concentration was most preferred by the sensory panelists. In-vitro digestion of optimized whey beverage revealed that bio-accessibility of zinc was significantly higher (p < 0.05) in complex form than free from., Supplementary Information: The online version contains supplementary material available at 10.1007/s13197-022-05497-y., Competing Interests: Conflict of interestThe authors have no conflict of interest to disclose with regard to the present work., (© Association of Food Scientists & Technologists (India) 2022, Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.)

One approach for reducing the level of environmental contamination threats around the world is to use renewable energy-harvesting equipment. Wind is a potential environmental resource that has become a desirable aspect of urban use due to advances in wind turbine design technology. Other variants have been developed based on the classic vertical-axis Savonius rotor model, which, according to experimental test findings and computational calculations, show higher operational characteristics performance. Generated power and shaft torque operational results are obtained by providing specific rotor blade shapes in these models, one of the most common designs, among small-scale rotor which uses a drag-based vertical axis whereas Savonius turbines having large-scale rotors not developed yet. This kind of rotor has the advantages of being simple to design, affordable, performing well at low speeds, and turns to flow direction independently. However, it was discovered that the Savonius rotor suffers through high quantity of negative torques created by the returning blade after a number of examinations into its performance. Many studies on various rotor types have been conducted to resolve the Savonius turbine's performance constraints. The research showed and analyzed the difficulties and modification in design parameters of rotor, as well as their major impact on rotor performance., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Wind energy is the second largest source of renewable energy, across the world. For designing and construction of wind farms, most critical information is consistent wind resource assessment forecasts and appropriate models of wind speed distribution for a particular site. The purpose of this study is to provide the wind characteristics and wind potential evaluation of offshore locations, in Gujarat in India, using the wind Weibull density function. The Weibull shape k and scale c parameters are computed using six distinct numerical approaches at two different heights, to determine wind power density. The LiDAR sensor was used to capture the time series wind data. The goodness of fit test, which includes the RMSE, R 2 , MAPE, and χ 2 is considered to evaluate the performance of the selected methods. Wind power densities are calculated from the acquired results with the help of estimated parameter values, all the methods used in this study were found to be appropriate for Weibull distribution parameters estimation. The MLM has been determined to offer the most accurate evaluation of wind potential. The WPD computed from observed wind data was compared to the obtained power densities of the specified region. The evaluated data is a considered as preliminary characteristic of wind potential that aids in the wind energy conversion and determining the actual wind potential of a specific site., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

In compliance with the European Medicine Agency guidance to detect any potential safety concerns associated with influenza vaccination, an enhanced safety surveillance study was conducted in England during the 2017/18 influenza season. The primary objective was to estimate the incidence rates of adverse events occurring within seven days of vaccination with Fluarix Tetra. In nine General Practices, seasonal influenza vaccine was administered to patients according to local guidelines. Events following immunization were collected using customized cards (enhanced component) combined with electronic health records [EHRs] (EHR component) to estimate incidence rates of adverse events experienced post vaccination. The study ran from 01-Sep-2017 to 30-Nov-2017. A total of 23,939 subjects were vaccinated of whom 16,433 received Fluarix Tetra. The cumulative incidence rates of adverse events of interest for Fluarix Tetra were 7.25% [95% CI, 5.95-8.73] for events reported by card alone, and 9.21% [95% CI, 7.37-11.34] when combined with EHR data. The type and frequency of events reported were consistent with the Fluarix Tetra Summary of Product Characteristics. The study supports and confirms the safety profile of Fluarix Tetra. ClinicalTrials.gov number: NCT03278067.

Introduction: Seasonal influenza causes numerous deaths worldwide each year. Annual vaccination for disease prevention is crucial. Seasonal vaccines are updated each year to closely match circulating strains., Objective: To comply with European Medicines Agency (EMA) guidance, an enhanced safety study was conducted to rapidly collect and assess adverse events (AEs) within 7 days following vaccination with GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in 2018/2019., Methods: A customised AE reporting card (AERC) and standardised electronic data reporting application were used in Belgium, Germany and Spain in adult and paediatric subjects in this study., Results: In 2018, 1060 subjects vaccinated with one dose of GSK's IIV4 were enrolled (all subjects in Belgium and Germany were adults, and 75% and 25% of subjects in Spain were children and adults, respectively). In Spain, 139 eligible children later received a second dose. Overall 1035 subjects completed the study. After dose 1 and dose 2, 98.3% and 100% of subjects, respectively, returned the completed AERC. Over the study period, 43.0% (456/1060 post dose 1) and 23.7% (33/139 post dose 2) of subjects reported at least one AE within 7 days after immunisation. The most frequently reported categories of AEs were General and Administration Site (e.g. injection site pain, swelling, erythema) and Respiratory Disorders (e.g. rhinorrhoea, cough, nasal congestion). There were no deaths and no serious AEs deemed related to GSK's IIV4., Conclusion: In compliance with EMA guidance, this study design allowed for near real-time assessment of AEs. No safety signals were detected at any point during the study period. The study supports and confirms the acceptable safety profile of GSK's IIV4. CLINICALTRIALS., Gov Identifier: NCT03688620.

Introduction: Influenza is an important cause of morbidity and mortality in Europe. Prevention by annual vaccination is most effective but with yearly vaccine reformulation to match circulating virus strains, vaccine safety must be continuously monitored. The European Medicines Agency published guidance on safety monitoring of influenza vaccines., Methods: An enhanced safety surveillance study of GSK's inactivated quadrivalent influenza vaccine (IIV4) was conducted in Belgium, Germany, and Spain in influenza season 2018/19. The objective was to collect adverse event (AE) reports from subjects within 7 days of vaccination. A customized AE reporting card (AERC) with predefined AEs of interest was used to rapidly detect and evaluate potential new safety concerns. Interim results are presented here., Results: Between week 40 and 52, 1060 vaccinated subjects were enrolled (31.0% Belgium, 26.2% Germany, and 42.7% Spain) covering all ages for which IIV4 is indicated (32.0% aged 6 months-17 years, 33.8% 18-65 years, and 34.2% over 65 years). Pediatric subjects  less than 9 years old (n = 139) received two doses. Following dose 1 and dose 2, 98.2% and 100%, respectively, returned the completed AERC recording any AEs. Following dose 1 and dose 2, 454 and 34 subjects, respectively, reported at least one AE (most frequently expected general and injection site symptoms and respiratory symptoms)., Conclusion: All reported AEs were expected as per summary product characteristics (smPC). No safety signals that impact public health or alter the benefit-risk profile of GSK's IIV4 were identified. Subjects from all vaccinated age groups were enrolled and the use of AERCs allowed rapid monitoring and analysis of reported AEs., Trial Registration: ClinicalTrials.gov identifier, NCT03688620., Funding: GlaxoSmithKline Biologicals SA.

Introduction: The European Medicines Agency requires Marketing Authorisation Holders providing seasonal influenza vaccines in Europe to conduct enhanced safety surveillance accounting for the different age groups based on the vaccine indication, in order to detect any potential increase of local and systemic adverse reactions early in an influenza season. To comply with this requirement, a multicountry European passive enhanced safety surveillance study has been set up to capture and assess adverse events occurring within 7 days following seasonal influenza vaccination. Here we share our surveillance protocol for the 2018/2019 influenza season., Methods: Nine healthcare professionals (HCPs) in Belgium, Germany and Spain have been recruited for this study. Cumulatively, approximately 1000 vaccinees will be provided with customised adverse event recording cards to report adverse events experienced within 7 days following vaccination with GSK's split-virion inactivated quadrivalent influenza vaccine. The cards are to be returned to the HCPs and the events encoded using an electronic case report form. Adverse event reporting rates will be analysed weekly and cumulatively, throughout the study period. Event rates will be described by country, age group and by influenza morbidity/mortality risk status of vaccinees (based on HCP assessment)., Ethics and Dissemination: Ethics committee approval was obtained for all participating sites prior to enrolment of the study participants. At the end of the study, each participating site will receive their data, and the outputs from the research will be made available to regulatory authorities. We intend to seek publication in peer-reviewed journals. GSK has posted a summary of the study protocol before the start of the study and results will be posted within 12 months of statistical analysis completion, in line with the National Institutes of Health recommendations., Trial Registration Number: NCT03688620., Competing Interests: Competing interests: VS declares he is employed by VPN Consultancy Limited working on behalf of the GSK group of companies. KS declares she is employed by Syneos Health working on behalf of the GSK group of companies. FL declares he is employed by 4Clinics Belgium working on behalf of the GSK group of companies. AS reports he was employed by the GSK group of companies at the time of the study and reports he holds shares in the GSK group of companies. EZ-v-D declares she is employed by the GSK group of companies. AY, GDS and SD declare they are employed by the GSK group of companies and hold shares in the GSK group of companies., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

The utility of a chiral Ru-prolinamide catalytic system has been demonstrated in one-pot synthesis of optically active β-triazolylethanol and β-hydroxy sulfone derivatives. The said methodology proceeds through asymmetric transfer hydrogenation of in situ formed ketones of the corresponding chiral products. Various chiral prolinamide ligands were screened, and ligand L6 with isopropyl groups substituted at the ortho position has shown excellent activity at 60 °C in aqueous medium producing up to 95% yield and 99.9% enantioselectivity., Competing Interests: The authors declare no competing financial interest.

Introduction: The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced safety surveillance (ESS) of seasonal influenza vaccines including a near real-time evaluation of collected data. The objective was to identify whether the use of passive surveillance or active surveillance provides different results of reported adverse events of interest (AEIs) by specified age strata and AEI type. We report the weekly incidence rates of AEIs within 7 days following seasonal influenza vaccination using passive and active surveillance., Methods: AEIs were collected within 7 days of vaccination from ten general practices predominantly administering inactivated quadrivalent influenza vaccine (IIV4, Fluarix Tetra, GSK). Vaccinees completed an adverse drug reaction (ADR) card. ADR card and medically attended AEIs data were recorded in practice electronic health records. We report the outcome of the first 5 weeks of safety surveillance (September 12, 2016-October 16, 2016); in an exploratory analysis, rates of AEI for IIV4 are compared to those passively reported through a sentinel network., Results: Practices vaccinated 13.1% (12,864/98,091) of their registered population; 5.6% (95% CI 5.20-6.00) of them reported AEIs, none serious. The most frequent were respiratory 2.60% (95% CI 2.33-2.88), musculoskeletal 1.82% (95% CI 1.59-2.05) and neurological 1.05% (95% CI 0.88-1.23). AEIs were more frequently reported for adults than for children; 5.91% (95% CI 5.49-6.34) compared to 1.49% (95% CI 0.69-2.29); 47.18% of the adults reported AEI using the ADR card, none were returned for subjects < 18 years old. The frequency of AEIs reporting was higher, 6.88% (95% CI 6.35-7.42) vs. 3.30% (95% CI 2.68-3.96, 100/3028, p < 0.000), through ESS than passive surveillance., Conclusion: The ESS did not reveal any safety signal and we demonstrated the feasibility of conducting ESS following EMA recommendations. The use of a customised ADR card led to a doubling of AEIs reports over passive surveillance in adults., Funding: GlaxoSmithKline Biologicals SA, Wavre, Belgium.

Background: Tooth is the hardest and chemically (except mineral contents) the most stable structure in the body, which makes teeth as the first-rate material for genetic and forensic investigations. Sex determination of skeletal remains forms an important part of archaeological and medicolegal examinations. Hence, the aim of the present study was to analyse the morphometric and dimensional variation between male and female in north Indian population using maxillary arch parameters., Materials and Methods: Fifty male and fifty female patients of age group 18-35 years were randomly selected after taking detail history. All maxillary impressions were made with alginate and poured in type III dental stone. These casts were measured for maxillary inter-canine width, maxillary first inter-premolar width, anteroposterior palatal width and palatal depth using a digital vernier caliper and findings were correlated with sexual dimorphism., Results: The maxillary inter-canine width, maxillary first inter-premolar width, and palatal depth showed a significant difference with P < 0.05 between the means of two populations. Anteroposterior palatal width showed the comparatively less significant difference between two populations., Conclusion: Among north Indian population, maxillary inter-canine width, maxillary first inter-premolar width, and palatal depth can be used for sex assessment. The anteroposterior palatal width parameter is comparatively less significant in sex determination., Competing Interests: There are no conflicts of interest.