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It will also provide the Combined Group with leading positions in rare diseases and plasma-derived therapies. Shire has strong expertise in rare diseases, an attractive modality diverse midand late-stage pipeline enriched with large-molecule programs, as well as cutting-edge technologies in gene therapy and recombinant proteins, and Takeda has a productive early stage development and research-orientated R&D program. The Acquisition will accelerate this transformation and will provide additional cash flow to continue to invest in its R&D engine and have a broader patient reach. The Takeda Directors expect recurring pre-tax cost synergies for the Combined Group to reach a run-rate of at least $1. Revenue growth potential In addition to the quantified financial benefits highlighted above, the Takeda Directors further expect that the Combined Group will be able to realise additional revenue synergies which have not been quantified at this stage. The foregoing statements of estimated cost savings and synergies relate to future actions and circumstances which, by their nature, involve risks, uncertainties and contingencies. As a result, the cost savings and synergies referred to may not be achieved, may be achieved later or sooner than estimated, or those achieved could be materially different from those estimated. For the purposes of Rule 28 of the Takeover Code and otherwise, the statements of estimated cost savings and synergies contained in this Announcement and the statements of intention, belief or expectation for the Combined Group and Takeda following completion of the Acquisition contained in this Announcement are solely the responsibility of Takeda and the Takeda Directors, and not of the Shire Directors. These statements are not intended as a profit forecast and should not be interpreted as such. Morgan Cazenove and Nomura, in connection with anticipated quantified financial benefits statements, as required by Rule 28. The bridge facility will be unsecured and have a maturity of 364 days from the date of funding. It is currently contemplated that prior to completion of the Acquisition the commitments under the Bridge Facility Agreement will be reduced or refinanced with a combination of long-term debt, hybrid capital and available cash resources. Takeda is committed to a strong balance sheet and intends to maintain its investment grade credit rating following completion of the Acquisition. Morgan Cazenove and Nomura, as financial adviser to Takeda, is satisfied that sufficient cash resources are available to Takeda to enable it to satisfy in full the cash consideration payable to Shire Shareholders under the terms of the Acquisition. Further information on the financing of the Acquisition will be set out in the Scheme Document.
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For research, the quality domains risks to public health from coming to a wrong are research design and processes and procedures, conclusion. These lists of components are most which address planning, design, data elements and likely incomplete, but the level of detail provided data sources, and ethics, privacy, and governance. For evidence, the quality domains are external validity, internal validity, and analysis and reporting. For registries where practice characteristics may infuence outcome, seek to include diverse clinical practices. Where possible, a broad range of patients (few exclusion criteria) is desirable to facilitate subgroup analysis. Defne patient outcomes clearly, especially for complex conditions or outcomes that may not have uniformly established criteria. Consider whether these outcomes will be collected from medical care providers, patients, or other observers. Consider whether or not the sample size requirement can be achieved within the available time and budget constraints. It may be helpful for stakeholders to have input to ensure clinical relevance and feasibility. If linkage of registry data to other sources is planned, consider the additional issues of protection of human subjects. Establish a data and coding dictionary to provide explicit defnitions and to describe coding used. Whenever possible, use standardized data dictionaries, such as the International Classifcation of Diseases, and use coding that is consistent with nationally or internationally approved coding systems to promote comparability of information among studies. Identify the individual(s) responsible for the integrity of the data, computerized and hard copy, and make sure these individuals have the training and experience to perform the assigned tasks. For safety studies, create a process for identifying and reporting serious events that is consistent with regulatory requirements.
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Two reviewers assessed the included studies for sources of systematic bias according to the guidelines in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions and evaluated the studies for the following criteria: sequence generation and allocation concealment (selection bias); masking of participants, study investigators, and outcome assessors (detection bias); incomplete outcome data (attrition bias); selective outcome reporting (reporting bias); and other sources of bias. Masking of investigators and participants was not possible with some of the interventions examined but was noted when mentioned. Two reviewers assessed the methodological rigor of observational studies using a modified 11 version of the Newcastle Ottawa Scale. The Newcastle Ottawa Scale includes domains to assess the quality of study group selection (representativeness, selection, case definitions); comparability of cohorts/cases and controls on the basis of the design or analysis; and ascertainment of exposures or outcomes, adequacy of followup, nonresponse rate, and financial or other conflicts of interest. We used the following criteria, adapted from Li, to determine which systematic reviews were of sufficient quality to be considered for inclusion in this review: comprehensive search for primary studies (searches of more than one bibliographic database), risk-of-bias assessment, appropriate methods of analysis. We abstracted evidence from additional primary studies for interventions, comparisons, and outcomes that were not addressed by existing systematic reviews, and we searched for and summarized evidence from additional primary studies that were published or identified after the date of the last search conducted for the systematic review. Due to appreciable variability in interventions, followup intervals, or assessments of outcomes, we did not combine the results of primary studies in a meta-analysis and instead present a narrative summary. The plan for the analysis of primary studies, including the assessments of heterogeneity, reporting bias, measures of treatment effect, data synthesis, and subgroup analysis, was included in the protocol for this review. Given the slowly progressive nature of glaucoma, the large trials of glaucoma therapy have demonstrated the need to follow hundreds of participants for 5 or more years to detect change. Future Research the available evidence demonstrates definitively that intraocular pressure can be lowered by medications, laser treatments, and surgery. Although it is logical to presume that slowing glaucoma damage would lead to preservation of vision-related quality of life and reduction in visual impairment, this link has not been demonstrated in the research literature. One specific area that would benefit from research is the association between treatment and visual impairment and/or patient-reported outcomes. One important reason such work has not yet been done is that the time from diagnosis to visual impairment in a treated glaucoma patient may be many years to decades. Another general area that requires additional evidence is the relative risks and benefits of medical and surgical treatments for glaucoma. The number of studies that adequately compare two or more treatments over time is too small to draw any significant conclusions about the comparative effectiveness of most currently used therapies. As a general comment on the available literature on glaucoma treatments, the field would benefit from more rigorous study design and more standardized reporting of outcomes. The World Glaucoma Association publication Guidelines on Design and Reporting of Glaucoma 15 Surgical Trials should serve as a basis for all trials of new and existing treatments. Ex-press shunt patients sustained a clinically important decrease Trabeculectomy vs.
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Hand hygiene should be applied immediately after gloves are removed, before and between patient contacts. A mask and eye protection as well as a gown should be worn to protect mucous 3 membranes, skin, and clothing during procedures that are likely to result in splashing of blood, body fluids, secretions, or excretions. Reusable equipment should be cleaned and sterilized before reuse and soiled linen should be transported in a (double) bag. Needles should not be recapped, and all used sharps instruments must be placed in designated punctureresistant containers. Examples of conditions necessitating isolation precautions and a summary of measures to be taken are shown in Tables 7. Wear a clean, nonsterile gown when entering, and remove it before leaving the room. Limit transport of patients to medically necessary purposes, and maintain isolation precautions during transport. Patients with excessive cough and sputum production should receive a single room first. Therefore, susceptible healthcare personnel are restricted from entering the rooms of patients known or suspected to have measles, varicella, disseminated zoster, or smallpox. As for the other infections requiring airborne precautions, patients with suspected or known infection by Mycobacterium tuberculosis should be nursed in a private room where the air flows in the direction from the hall into the room (negative air pressure), with 6 to 12 (optimal) air changes per hour, and appropriate discharge of air outdoors. Cohorting can be done in rare circumstances for patients infected with strains presenting with an identical antimicrobial susceptibility. However, a moulded surgical mask may be as effective in dealing with healthcare associated outbreaks and better complied with because of cost. However, if transport is unavoidable, the patient should wear a surgical mask that covers both mouth and nose. Aerosol generating procedures should be limited or else performed in the room or more ideally in an airborne 11 infection isolation room if feasible. Hospitals are encouraged to review the recommendations and to modify them according to what is feasible and achievable. Monitoring of the compliance with isolation procedures in a continuous improvement program. Effective discharge planning for patients in isolation to be transferred to other healthcare facilities and effective admission planning for patients at risk of carrying infectious agents from other hospitals or nursing homes. Increased compliance of patients with the precautions through supportive efforts to facilitate adherence and through education about the mechanism of transmission and the reason for being placed in isolation.
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Alzheimer Europe estimates this number at 4,731,576 in the current 15 Member States, which corresponds to a prevalence rate of 1. Vascular dementia is the second most common form of dementia and it is generally accepted that it accounts for between 25 and 50% of all cases of dementia. For the purpose of our report, we have therefore concluded that all other forms of dementia account for maximum 25% of all forms of dementia, which would give us a prevalence rate of 31. Fronto-temporal degeneration and Lewy body diseases would be the commonest of these rarer forms of dementia and it is generally accepted that they account each for about 5% of all cases of dementia or 7. We found some 30 diseases or disease groups which are either rare in themselves or which lead to dementia in rare cases. For each disease we provide general outline, describe the symptoms and course, the causes and risk factors, the genetics, the frequency, the diagnostic procedures, as well as information on care and treatment, ongoing research and available services. The expert group discussed possible ways on how to present these diseases and we ultimately opted for a classification system based on the causes of dementia, as this system had the advantage of grouping related diseases. The biggest group of diseases is made up of degenerative diseases, which are characterised by a progressive loss of nerve cells and synapses. For most of these 5 Alzheimer Europe Rare Forms of Dementia Project diseases, the causes of this nerve loss are unknown and our knowledge about possible treatment or prevention remains limited. Metabolic diseases are a group of often treatable diseases which may lead to dementia and which are caused by an under-activity or over-activity of a part of the human metabolism. Traumatic diseases are caused by a trauma and in the disease described in this report by repeated head trauma. Toxic diseases are caused by the consumption of substances, which are harmful to the human body. Cerebro-vascular diseases are diseases of the blood vessels in the brain, which are the second most common cause for dementia. When describing the various diseases, we have attempted to be as complete as possible, yet we also noted that for a lay reader some information may be too technical or that repetitions between various diseases would have become necessary. For these reasons, the expert group decided to include some introductory chapters to the disease definitions. At the same time, she raises some of the ethical points involved in genetic testing. Despite this they have a major impact on health and social services, voluntary organisations, carers families and patients.
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