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Taking into account its previous assessment on EFSA-GMO-NL-2009-75 and the outcome of the 28-day toxicity study in mice with the GOXv247 protein provided in this mandate, the GMO Panel, based on a weight of evidence approach, concludes that food and feed containing, consisting and produced from genetically modified oilseed rape Ms8 × Rf3 × GT73 and its sub combinations Ms8 × GT73 and Rf3 × GT73, are as safe as its conventional counterpart, according to the scope as defined in the application EFSA-GMO-NL-2009-75.Following the submission of application EFSA-GMO-RX-002 under Regulation (EC) No 1829/2003 from Monsanto Company, the Panel on Genetically Modified Organisms of EFSA (GMO) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide-tolerant genetically modified oilseed rape GT73. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in oilseed rape GT73 considered for renewal of authorisation is identical to the sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA-GMO-RX-002 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on oilseed rape GT73.Following an application from DuPont Nutrition Biosciences ApS submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Bifidobacterium animalis subsp. lactis Bi-07 (Bi-07) and contribution to increasing lactose digestion. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is Bi-07. The Panel considers that Bi-07 is sufficiently characterised. The claimed effect proposed by the applicant is 'improvement of lactose digestion'. The Panel considers that increasing lactose digestion is a beneficial physiological effect for individuals with lactose maldigestion provided that the symptoms of lactose maldigestion are improved. Two human intervention studies which investigated a single dose effect of Bi-07 on lactose digestion using the hydrogen breath test, as well as on gastrointestinal symptoms were submitted. These studies show that consumption of Bi-07 (1012 CFU) increases lactose digestion in individuals with lactose maldigestion and that Bi-07 exhibits lactase activity in vitro. However, these studies provide no evidence that increasing lactose digestion through the consumption of Bi-07 (1012 CFU) improves gastrointestinal symptoms of lactose maldigestion, which is considered a beneficial physiological effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Bifidobacterium animalis subsp. lactis Bi-07 and a beneficial physiological effect (i.e. the improvement of symptoms of lactose maldigestion) in individuals with lactose maldigestion.Olecranon fractures and osteotomies are treated with either tension-band wiring or plate-screw fixation; however, these methods of fixation have high rates of symptomatic hardware, resulting in revision surgery. We describe the novel use of intramedullary noncannulated long screws to gain rigid internal fixation and allow early range of motion. Our procedure differs from traditional intramedullary olecranon fixation as the longer screws, which can commonly be found on many pelvic fixation sets, allow for endosteal purchase at the isthmus of the ulna, which increases the pull-out strength of the screw. https://www.selleckchem.com/products/atglistatin.html This procedure can be done quickly and requires minimal exposure, which minimises anaesthetic exposure, blood loss, and tourniquet time. The construct is not palpable subcutaneously and therefore is less likely to result in symptomatic hardware and revision surgery. Oitment C, Koziarz A, Bozzo A, Intramedullary Cancellous Screw Fixation of Simple Olecranon Fractures. Strategies Trauma Limb Reconstr 2019;14(3)163-167. Oitment C, Koziarz A, Bozzo A, et al. Intramedullary Cancellous Screw Fixation of Simple Olecranon Fractures. Strategies Trauma Limb Reconstr 2019;14(3)163-167. We present details of a surgical technique to create an intramedullary canal to allow intramedullary fracture fixation in patients with osteopetrosis. Clinical cases are used to facilitate the description. Osteopetrosis is a rare, hereditary condition characterised by hard, brittle, "marble bone;" primarily due to osteoclast dysfunction. Patients are prone to fractures and subsequently nonunions, periprosthetic fractures, and metal-ware failure are commonly seen. Due to the increased bone density, deformity, and obliteration of the medullary cavity, fracture fixation is also technically demanding. Creation of a medullary canal allows the use of intramedullary fixation rather than plate and screws for long-bone fractures. A new sharp drill bit should be used for each case as blunt drills are more likely to break.Bone is drilled in a pulsatile fashion, with withdrawal every 2-4 seconds for bone swarf to be removed.Constant cooling of the drill bit with saline to help prevent bone necrosis and drill breakage.Regular exchanging of drill bit sizes to expand the canal. The smaller drills start the canal and are used to direct progress. Sequential expansion during canal creation is preferred.Regular use of orthogonal radiographs to ensure correct canal positioning and prevent perforation. The creation of an intramedullary canal allows intramedullary fracture fixation. In our experience, this technique gives the orthopaedic surgeon a safe and effective method for treating long-bone fractures in patients with osteopetrosis. Fractures and nonunions in patients with osteopetrosis are difficult to manage; and by detailing this technique, a further option is now available for surgeons when deciding upon fixation method. Kent J, Ferguson D. Intramedullary Canal-creation Technique for Patients with Osteopetrosis. Strategies Trauma Limb Reconstr 2019;14(3)155-162. Kent J, Ferguson D. Intramedullary Canal-creation Technique for Patients with Osteopetrosis. Strategies Trauma Limb Reconstr 2019;14(3)155-162.
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