A Multi-centre Randomised Controlled Non-inferiority Trial to Compare the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies Versus First-line ACTs + Placebo for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Asia

A partially blinded randomised controlled non-inferiority trial comparing the efficacy, tolerability and safety of Triple ACTs artemether-lumefantrine + amodiaquine (AL+AQ) and artesunate- mefloquine+piperaquine (AS-MQ+PPQ) with the ACTs artemether-lumefantrine + placebo (AL+PBO) and artesunate- mefloquine + placebo (AS-MQ+PBO) (with single-low dose primaquine in some sites) for the treatment of uncomplicated Plasmodium falciparum malaria to assess and compare their efficacy, safety, tolerability.

Start Date30 Jun 2021

Sponsor / Collaborator

University of Oxford

NCT04847661 / CompletedPhase 2/3IIT

Efficacy of Mefloquine as Prophylaxis Against COVID-19: A Placebo-control, Randomized Clinical Trial

The aim of this study is to evaluate the efficacy and safety of Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed. This study is an open-label, randomized, placebo controlled trial.
A total of 1500 household contacts of COVID-19 confirmed cases who will attend triaging clinic of 5 Egyptian university centers (Helwan university hospital, Ain Shams university hospital, Assiut University Hospital, Fayoum university hospital and Tanta university hospital). The household contacts of COVID-19 confirmed subjects with a decision for home-isolation will be recruited to participate into this study. The recruited subjects from each center will be randomly assigned (locally in that center) into 2 groups (750 volunteer in each group). The 1st group will receive Mefloquine (1100-1650 mg according to body weight), orally, while the other group will receive the same number of placebo tablets (control group). Previous infection will be excluded for all recruited subjects by testing for the presence of anti-bodies against COVID-19 to exclude previous infection. Subjects who are tested negative will be allocated into one of the 2 study groups after randomization, and treatment will be started immediately (either mefloquine or placebo). In addition, a nasopharyngeal swap will be taken from each recruited subject and tested by PCR for COVID-19 to exclude current infection. After having the PCR results, positive cases will be analyzed separately to test for the disease severity.
Neurological and cardiac assessment will be done for all volunteers before recruitment to exclude the presence of any contraindication for Mefloquine intake. Both groups will be followed up clinically to detect any symptom or sign of COVID-19 infection for 2 weeks (during the period of home isolation). Nasopharyngeal swap with PCR for COVID-19 will be done for all included subjects at the end of the follow-up period (14 days), or at the appearance of symptoms or signs suggesting COVID-19 infection.
Primary end points of the study are either:
End of follow up period (2 weeks)
Confirmed diagnosis of COVID-19 infection during the study time Initial severity assessment of COVID-19 infection will be done in all infected subjects in both groups to compare severity, in addition to following up of the fate of the infected subjects.

Start Date28 Mar 2021

Sponsor / Collaborator

Helwan University

[+4]

NCT04347031 / CompletedPhase 2/3IIT

An Open Randomized Study of the Effectiveness of the Drug Mefloquine, Tablets 250 mg, Produced by FSUE SPC "Farmzashita" of the Federal Medical Biological Agency, FMBA of Russia (Russia) for the Treatment of Patients With COVID19

Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.

Start Date08 Apr 2020

Sponsor / Collaborator-

100 Clinical Results associated with Mefloquine Hydrochloride

100 Translational Medicine associated with Mefloquine Hydrochloride

100 Patents (Medical) associated with Mefloquine Hydrochloride

3,044

Literatures (Medical) associated with Mefloquine Hydrochloride

01 Jan 2025·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

Chiral separation and spectroscopic characterization of mefloquine analogues

Article

Author: Dobšíková, K. ; Dobšíková, K ; Setnička, V ; Kohout, M ; Setnička, V. ; Kohout, M.

Mefloquine, a widely used antimalarial agent, has spurred ongoing research into the development of derivatives with enhanced efficacy and reduced side effects. In this investigation, we synthesized two compounds containing N-allyl or N-tert-butylacetamid groups. A chiral liquid chromatography with polysaccharide chiral stationary phase was utilized to separate the enantiomers of both derivatives. We employed spectroscopic chiroptical and non-polarizable methods such as electronic and vibrational circular dichroism, infrared absorption and ultraviolet spectroscopies. Combined with density functional theory calculations, the stable conformers were found in solution and their spectra were subsequently simulated. We elucidated the three-dimensional structure of the enantiomerically pure compounds and assigned the absolute configuration of all prepared derivatives using both experimental and simulated spectra.

06 Nov 2024·Antimicrobial Agents and Chemotherapy

Analogs of the anti-malaria drug mefloquine have broad-spectrum antifungal activity and are efficacious in a model of disseminated Candida auris infection

Article

Author: Williams, Noelle S. ; Krysan, Damian J. ; Andes, David R. ; Meyers, Marvin J. ; Wang, Xiaoyu ; Zarnowski, Robert ; Guin, Soumitra ; Montoya, Marhiah C.

ABSTRACT Only three classes of antifungal drugs are currently in clinical use. Here, we report that derivatives of the malarial drug mefloquine have broad-spectrum antifungal activity including difficult-to-treat molds and endemic fungi. Pharmacokinetic and efficacy studies of NSC-4377 indicate that it penetrates the central nervous system and is active against Candida auris in vivo . These data strongly support the further development of mefloquine analogs as a potentially new class of antifungal molecules.

01 Nov 2024·Infectious Disorders - Drug Targets

Insight into the Natural Biomolecules (BMs): Promising Candidates as Zika Virus Inhibitors

Review

Author: Singh, Alka ; Semwal, Amit ; Garg, Ruchika ; Dobhal, Kiran

Abstract:Zika virus (ZIKV) is among the relatively new infectious disease threats that include SARS-CoV2, coronavirus, monkeypox (Mpox) virus, etc. ZIKV has been reported to cause severe health risks to the fetus. To date, satisfactory treatment is still not available for the treatment of ZIKV infection. This review examines the last five years of work using natural biomolecules (BMs) to counteract the ZIKV through virtual screening and in vitro investigations. Virtual screening has identified doramectin, pinocembrin, hesperidins, epigallocatechin gallate, pedalitin, and quercetin as potentially active versus ZIKV infection. In vitro, testing has shown that nordihydroguaiaretic acid, mefloquine, isoquercitrin, glycyrrhetinic acid, patentiflorin-A, rottlerin, and harringtonine can reduce ZIKV infections in cell lines. However, in vivo, testing is limited, fortunately, emetine, rottlerin, patentiflorin-A, and lycorine have shown in vivo anti- ZIKV potential. This review focuses on natural biomolecules that show a particularly high selective index (>10). There is limited in vivo and clinical trial data for natural BMs, which needs to be an active area of investigation. This review aims to compile the known reference data and discuss the barriers associated with discovering and using natural BM agents to control ZIKV infection.

News (Medical) associated with Mefloquine Hydrochloride

26 Jan 2023

·www.prnewswire.com

Ascletis Announces IND Approval of Oral Viral Polymerase Inhibitor ASC10 for Monkeypox Indication by China NMPA

--Preclinical studies show that ASC10-A, the active metabolite of double prodrug ASC10, has potent antiviral activities against both monkeypox and SARS-CoV-2 viruses --Ascletis has received the Notice of Issuance from the United States Patent and Trademark Office (USPTO) for the patent application of ASC10 and its derivatives, and their uses to treat multiple virus infections HANGZHOU and SHAOXING, China, Jan. 26, 2023 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces that the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application of ASC10 for monkeypox indication. ASC10 is an oral double prodrug. After oral administration, both ASC10 and single prodrug molnupiravir are rapidly and completely converted in vivo into the same active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931. Preclinical studies show that ASC10-A has broad spectrum antiviral activities including potent activities against both monkeypox and SARS-CoV-2 viruses. Ascletis has received the Notice of Issuance from the United States Patent and Trademark Office (USPTO) for the patent application of ASC10 and its derivatives, and their uses to treat multiple virus infections including SARS-CoV-2, monkeypox virus and respiratory syncytial virus (RSV). Ascletis is the first Chinese biotech company which has been granted a patent by the USPTO for its in-house developed oral viral polymerase inhibitor and its derivatives. Monkeypox virus is an orthopoxvirus that causes a disease with symptoms similar to smallpox[1]. As of January 25, 2023, over 85,106[2] confirmed cases have been reported globally and monkeypox virus has spread in 110 countries[2] according to data from World Health Organization (WHO). Data from in vitro antiviral cellular assay with infectious monkeypox virus, a study sponsored by Ascletis and conducted at IIT Research Institute (IITRI) of Illinois Institute of Technology in Chicago, U.S., showed that ASC10-A has potent antiviral activity against monkeypox virus, suggesting that ASC10 has the potential to be an effective treatment of monkeypox virus infection. In August 2022, researchers from National Institute of Infectious Diseases, Tokyo, Japan，tested 132 drugs and the results showed that molnupiravir (active metabolite ASC10-A) and other two drugs have potent cellular antiviral activity in the infectious monkeypox virus assay[3]. The rest of 129 drugs such as remdesivir, favipiravir, sofosbuvir and ribavirin, etc. do not have antiviral activities against monkeypox virus[3]. "I'm very glad that the IND application of ASC10 for monkeypox bas been approved by China NMPA, which further validates Ascletis' in-house R&D capabilities on viral diseases. Currently, there is no approved treatment for monkeypox in the world. We hope that ASC10 will make a contribution to the control of monkeypox globally." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. [1] [2] [3] Daisuke Akazawa, Hirofumi Ohashi, Takayuki Hishiki, et al. Potential anti-monkeypox virus activity of atovaquone, mefloquine, and molnupiravir, and their potential use as treatments. bioRxiv preprint. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 22 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne). For more information, please visit . SOURCE Ascletis Pharma Inc.

Drug ApprovalClinical StudyClinical ResultIND

26 Oct 2022

·www.biospace.com

Ascletis Announces U.S. IND Filing of Oral Antiviral ASC10 for Monkeypox Indication

--ASC10 has two indications: monkeypox and SARS-CoV-2 virus infections. The Investigational New Drug (IND) application of the latter was approved by the U.S. Food and Drug Administration (FDA) in August 2022 and Phase Ib clinical trial in COVID-19 patients is underway in the U.S. --Preclinical studies shows that ASC10 has potent antiviral activities against both monkeypox and SARS-CoV-2 viruses --The IND filing of ASC10 for monkeypox indication in the U.S. will further broaden Ascletis' pipeline portfolio in viral diseases HANGZHOU and SHAOXING, China, Oct. 26, 2022 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces that the Investigational New Drug (IND) application of ASC10, an oral antiviral drug candidate targeting viral polymerase of monkeypox virus, has been filed with the U.S. Food and Drug Administration (FDA). ASC10 is an orally bioavailable and broad antiviral spectrum double prodrug which has a new and differentiated chemical structure from the single prodrug molnupiravir. After oral administration, both ASC10 and molnupiravir are rapidly and completely converted in vivo into the same active metabolite ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or EIDD-1931. Ascletis has filed multiple patent applications globally for ASC10 and its use in viral diseases including monkeypox virus infection. The data from the in vitro antiviral cellular assay with infectious monkeypox virus demonstrated that ASC10-A has potent antiviral activity against monkeypox virus, suggesting that ASC10 has the potential to be an effective treatment of monkeypox virus infection. This study was conducted at IIT Research Institute, headquartered at Illinois Institute of Technology in Chicago, U.S. and sponsored by Ascletis. In August 2022, a research paper was published by Dr. Watashi et al. at the National Institute of Infectious Diseases, Tokyo, Japan[1]. In this research, Dr. Watashi et al. tested 132 drugs and showed that molnupiravir (active metabolite ASC10-A) and other two drugs have potent cellular antiviral activity in the infectious monkeypox virus assay. The rest of 129 drugs such as remdesivir, favipiravir, sofosbuvir and ribavirin, etc. do not have antiviral activities against monkeypox virus. Monkeypox virus is an orthopoxvirus that causes a disease with symptoms similar to smallpox[2]. As of October 26, 2022, there had been over 75,000[3] confirmed cases globally and monkeypox virus had been spread in over 100 countries[3] according to data from World Health Organization (WHO). In particular, a total of 28,061[4] confirmed monkeypox/orthopoxvirus cases have been reported in the U.S. In China, the first confirmed case was reported on September 19, 2022. WHO assesses the risk of monkeypox virus in the European Region and the Region of the Americas as high[3]. By applying a double prodrug strategy, ASC10's permeability in Caco-2 cells (human colorectal adenocarcinoma cells) and active metabolite exposure in monkeys reached 3.2-fold and 2.1-fold of molnupiravir's, respectively. Studies have demonstrated[5,6] that ASC10-A has potent cellular antiviral activity against various Omicron variants (BA.1 EC50=0.3 µM; BA.2 EC50=0.25 µM; BA.5 EC50=0.23 µM; BA.2.75 EC50=0.90 µM). The Phase Ib clinical trial in COVID-19 patients is underway in the U.S. "As China's leading biotech company in antiviral area, Ascletis is dedicated to applying our sciences to address the challenges of viral diseases. Currently there is no treatment approved for monkeypox virus infections globally. This IND filing of ASC10 for monkeypox in the U.S. will further broaden Ascletis' pipeline portfolio in viral diseases, and may provide a solution to monkeypox virus infections." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. [1] Daisuke Akazawa, Hirofumi Ohashi, Takayuki Hishiki, et al. Potential anti-monkeypox virus activity of atovaquone, mefloquine, and molnupiravir, and their potential use as treatments. bioRxiv preprint. [2] [3] [4] [5] Takashita E, Yamayoshi S, Fukushi S, et al. Efficacy of Antiviral Agents against the Omicron Subvariant BA.2.75. N Engl J Med. 2022; 387(13): 1236-1238 [6] In-house studies About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has three marketed products, i.e. ritonavir tablets, GANOVO® and ASCLEVIR®, and 20 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (HBV functional cure), ASC10 and ASC11(oral small molecules for COVID-19 treatment), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis), and ASC40 (acne). For more information, please visit . Company Codes: HongKong:1672

Small molecular drug

26 Aug 2021

·www.biospace.com

Antimalarial Drugs Market to See Record Break Revenue $1,019,396 Thousand and Registering at a 4.6% CAGR by 2026

Increase in incidence of malaria, rise in healthcare expenditure worldwide, and presence of large number of pipeline products fuel the growth of the global antimalarial drugs market. According to the report published by Allied Market Research, the global antimalarial drugs market was estimated at $711,360 thousand in 2018 and is expected to hit at $1,019,396 thousand by 2026, registering a CAGR of 4.6% from 2019 to 2026. Rise in prevalence of malaria, increase in healthcare expenditure worldwide and presence of large number of pipeline products propel the growth of the global antimalarial drugs market. Conversely, poor demand in underdeveloped countries curtails down the growth to some extent. Nevertheless, development in emerging economies is expected to create lucrative opportunities in the near future. Request Sample Report at: Covid-19 Scenarios- However, certain studies showed that the use of antimalarial drugs on some patients has increased the risks of hazardous disturbances. The demand and manufacturing of antimalarial drugs have been dramatically increased during the initial phase of Covid-19, as antimalarial drugs were believed to be effective in treating novel coronavirus. Malaria is a deadly infectious disease, which is transmitted through the bite of female Anopheles mosquito. The infection spreads to liver cells where the parasites multiply at a fast rate to invade red blood cells. These parasites further grow and mature in red blood cells to form merozoites, which are released upon the rupture of red blood cells to invade other blood cells. This leads to fever, tiredness, vomiting, headaches, impaired consciousness, multiple convulsions, and abnormal bleeding. Hence, the drugs which are employed in the treatment of malarial infection are called as antimalarial drugs. There are different types of antimalarial drugs such as quinine, chloroquine, proguanil, mefloquine, pyrimethamine, and others available in the market. The global antimalarial drugs market is segmented on the basis of drug class, distribution channel, and region. Based on drug class, the quinine segment contributed to more than one-fifth of the global antimalarial drugs market revenue in 2018. In addition the segment is expected to maintain its dominance by the end of 2026. The same segment would also portray the fastest CAGR of 4.7% during the study period. This is attributed to the fact that quinine is widely used for malaria treatment. Based on distribution channel, the retail pharmacy segment held the major share in 2018, garnering more than three-fifths of the global antimalarial drugs market. This is owing to the strong presence of retail pharmacies around the globe and convenience offered by them. However, the e-commerce websites and online drug stores segment would grow at the fastest CAGR of 5.9% throughout the forecast period. This is due to rise in preference for online purchasing of drugs over the traditional methods, increase in awareness of online pharmacy, and rise in number of internet users. Based on region, LAMEA accounted for 94% of the total market revenue in 2018, and is projected to maintain the lion’s share till 2026. Simultaneously, the Asia-Pacific region would manifest the fastest CAGR of 5.6% from 2019 to 2026. The other provinces analyzed in the market report take in Europe and North America. Access Full Report: The Major Key Players Are: Alvizia Healthcare Pvt. Ltd., Bayer AG, F. Hoffmann-La Roche Ltd, GlaxoSmithKline Plc, Ipca Laboratories Ltd., Merck & Co., Inc, Novartis AG, Pfizer Inc., Sun Pharmaceutical Industries Ltd. (Ranbaxy Laboratories), and Zydus Cadila. Trending Reports: Anti-Counterfeit Packaging Market - Global Opportunity Analysis and Industry Forecast, 2021–2030 Abdominal Aortic Aneurysm (AAA) Repair Devices Market - Opportunity Analysis and Industry Forecast, 2021–2030 About Us Allied Market Research (AMR) is a full-service market research and business-consulting wing of Allied Analytics LLP based in Portland, Oregon. Allied Market Research provides global enterprises as well as medium and small businesses with unmatched quality of "Market Research Reports" and "Business Intelligence Solutions." AMR has a targeted view to provide business insights and consulting to assist its clients to make strategic business decisions and achieve sustainable growth in their respective market domain. We are in professional corporate relations with various companies and this helps us in digging out market data that helps us generate accurate research data tables and confirms utmost accuracy in our market forecasting. Allied Market Research CEO Pawan Kumar is instrumental in inspiring and encouraging everyone associated with the company to maintain high quality of data and help clients in every way possible to achieve success. Each and every data presented in the reports published by us is extracted through primary interviews with top officials from leading companies of domain concerned. Our secondary data procurement methodology includes deep online and offline research and discussion with knowledgeable professionals and analysts in the industry. Contact: David Correa 5933 NE Win Sivers Drive #205, Portland, OR 97220 United States USA/Canada (Toll Free): +1-800-792-5285, +1-503-894-6022, +1-503-446-1141 UK: +44-845-528-1300 Hong Kong: +852-301-84916 India (Pune): +91-20-66346060 Fax: +1(855)550-5975 help@alliedmarketresearch (dot) com

100 Deals associated with Mefloquine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D00831	Mefloquine Hydrochloride	P01BC02	DB00358

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Leukoencephalopathy, Progressive Multifocal	Phase 3	BR	Biogen, Inc.	01 Jan 2009
Malaria, Falciparum	Phase 3	BF	Pfizer Inc.	01 Nov 2006
Malaria, Falciparum	Phase 3	ZM	Pfizer Inc.	01 Nov 2006
Malaria, Falciparum	Phase 3	KE	Pfizer Inc.	01 Nov 2006
Rheumatoid Arthritis	Phase 3	US	Nxera Pharma Co., Ltd.	01 Aug 2005
Malaria, Falciparum	Phase 1	ML	Pfizer Inc.	01 Nov 2006
Malaria, Falciparum	Phase 1	GH	Pfizer Inc.	01 Nov 2006
Malaria, Falciparum	Phase 1	SN	Pfizer Inc.	01 Nov 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERS2015	Not Applicable	-	113	Mefloquine	fdebssgaqp(vdlcmwrcss) = pysbmhpuzj upembmvsue (lodagmvxfl )	Positive	01 Sep 2015
NCT01615822 (CTgov)	Phase 1	Malaria	25	OZ439 100mg (OZ439 100mg Single Dose)	haswvviuro(eskxewoeip) = vynhpiwwzn fbobrinhdf (tkeooxgvtt, zypiiepvqz - qynnanfvyk) View more	-	26 Mar 2015
				OZ439 100mg+MQ 250 mg, single dose (OZ439 100mg Plus MQ 250mg Single Doses)	haswvviuro(eskxewoeip) = ynabfmfrfu fbobrinhdf (tkeooxgvtt, knqozsqfpr - kymtaubxvy) View more
NCT00811421 (Pubmed \| PLoS Med)	Not Applicable	Malaria	5,820	Sulfadoxine-pyrimethamine (SP)	cepakqhcgz(uxtvqalbiq) = didrdpnbed hlympqyksj (tyatnytver ) View more	-	01 Sep 2014
				Mefloquine (MQ)	cepakqhcgz(uxtvqalbiq) = kwieuvqpnw hlympqyksj (tyatnytver ) View more
Pubmed \| PLoS Negl Trop Dis	Not Applicable	Schistosomiasis Haematobia	-	Praziquantel	uccnjkanvn(fhincvfxdk) = drubjwazss tggtfzlesq (hywkvkalsf, 11 - 55) View more	-	01 Jul 2014
				Mefloquine+Praziquantel	uccnjkanvn(fhincvfxdk) = dhgvybfeyn tggtfzlesq (hywkvkalsf, 5 - 48) View more
NCT01132248 (Pubmed \| Clin Infect Dis)	Phase 2	Schistosomiasis Haematobia	65	Mefloquine	tqmoxsueei(odmoropefb) = qihmftwdti zgjmyksfhh (rekslfjrfc, 36% - 70%)	-	01 Mar 2013

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