Sharma A. M., Bakris G., Neutel J. M., et al. Therefore, it is also employed in the treatment of cerebrovascular stroke, neurodegenerative diseases, leukemia, breast cancer, and so forth either alone or in combination with other drugs. Use of the forums is subject to our Terms of Use Nevertheless, the number of patients was considered relatively low for arriving at a definite conclusion. Evaluation of palatability of 10 commercial amlodipine orally disintegrating tablets by gustatory sensation testing, OD-mate as a new disintegration apparatus and the artificial taste sensor. Bethesda, MD 20894, Web Policies 7 users are following. Polyethylene glycol 400 was used as a plasticizer in a 2% concentration in each formulation. One of the suspensions was made by using methylcellulose (1%) in syrup and the other using a 1:1 mixture of commercially available extemporaneous syrup vehicles, Ora-Plus and Ora-Sweet. Bashir S., Sherwani M. U., Shabbir I., Batool A. Efficacy of fix dose combination (atorvastatin and amlodipine) in treatment of uncontrolled hypertension and dyslipidemia. Liposomes are spherical vesicles with at least a single lipid bilayer that are used to deliver a drug to a specific site or target in the body and to overcome any stability or toxicity related problems of the drug. Citrulline is an important amino acid for the urea cycle, which helps your body to get rid of harmful substances like ammonia. Statistical analysis software program was used for the statistical analysis. The biochemical analyses performed during the baseline and final visits were as follows: fasting plasma glucose, serum total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglyceride, sodium, potassium, calcium, chloride, uric acid, blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, creatine kinase, complete blood count, and urinalysis (microalbuminuria and microscopic urine analysis). Owen says that the ibuprofen OTC dose should not exceed 400mg (two of the 200mg pills) every 6 hours. Sarafidis P. A. Accordingly, it can be said that the present study is valuable in terms of evaluating and demonstrating the efficacy and safety of S-amlodipine in a different population. Eventually, I weabed myself off of the 5mg (& monitored by BP) and told my Dr. that I would not take it anymore. Npoje s vysokm obsahom antioxidantov, ako s vitamny C a E, preukzatene zlepuj erektiln funkciu tm, e brnia pokodeniu buniek, produkujcich oxid dusnat," hovor Pearlmanov. Although the number of enrolled patients was lower than the estimated number, the results reached to a power of 80% for the primary end point (the change in SBP from the baseline [day 1] to fourth week [day 28]) and for almost all objectives in the treatment-naive arm. oral solution 1mg/mL (Norliqva) Hypertension Indicated for hypertension, to lower blood pressure Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily. Not much information regarding the formulations is available as the studies are more clinically oriented and the combinations have been discussed with respect to their clinical outcomes only in majority of the cases. Due to this activity, targeted delivery of AD in liposomal preparations, either alone or in combination with other drugs, has been employed by various workers with significant success [124, 125, 129]. For an effective treatment, it is of utmost importance to deliver the drug in a suitable dosage form through an appropriate route. Read our editorial policy. Comparison of single-pill strategies first line in hypertension: perindopril/amlodipine versus valsartan/amlodipine. There is no conflict of interests regarding the publication of this paper. The drug combinations with AD include aliskiren and hydrochlorothiazide [98, 99], olmesartan and hydrochlorothiazide [67, 100102], and valsartan and hydrochlorothiazide [88, 95, 101103]. ADB was released from microspheres with a sustained action of over 8h. The drug entrapment efficiency of the microspheres was found to be affected by drug and polymer concentrations. Combination therapy was more effective than amlodipine or valsartan monotherapy in reducing BP in patients with mild to moderate hypertension, and more effective than amlodipine monotherapy in reducing BP in patients with moderate to severe (stage 2) hypertension. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Results from a 12 months, randomized, clinical trial comparing an olmesartan/amlodipine single pill combination to olmesartan and amlodipine monotherapies on blood pressure and inflammation. More common side effects. Mainardes R. M., Urban M. C., Cinto P. O., Chaud M. V., Evangelista R. C., Gremio M. P. D. Liposomes and micro/nanoparticles as colloidal carriers for nasal drug delivery. Always speak to your doctor before acting and in cases of emergency seek Changes in SBP after 4weeks of treatment with S-amlodipine 2.5 mg/d are demonstrated in Table 2 and in Figure 2. 23. Motozato K., Miura S.-I., Shiga Y., et al. It is well absorbed after oral administration and has a bioavailability of around 6065% [7]. The site is secure. VigRX Plus has been available on the market since 2004. as being in breach of those terms. The aim of the present study was to evaluate the efficacy and safety of S-amlodipine 2.5 and 5 mg/d in patients with hypertension who were treatment-naive or previously received antihypertensive monotherapy. Exforge contains a combination of amlodipine and valsartan. Children's dosage. Im hoping that my hair starts to get strong again and that the damn water retention goes fingers crossed! The fast dissolving oral ADB tablets were prepared by direct compression method using croscarmellose (Ac-Di-Sol), crospovidone (Kollidon CL), and sodium starch glycolate as superdisintegrants in varying concentrations of 2, 4, and 6%. Before AD is a photosensitive drug and requires protection from light. Posted Effect of stealthy liposomal topotecan plus amlodipine on the multidrug-resistant leukaemia cells in vitro and xenograft in mice. government site. Patients with major protocol deviations were excluded from the study. The main drawback of using orally disintegrating or crushed tablets of AD is their bitter taste [16, 18, 19] and, therefore, taste masking of such dosage forms is very important to increase palatability [15]. sharing sensitive information, make sure youre on a federal And my ankles turned into sausages. Fukui-Soubou M., Terashima H., Kawashima K., Utsunomiya O., Terada T. Efficacy, safety, and palatability of RACTAB formulation amlodipine orally disintegrating tablets. Amlodipine has the same contraindications as other DHPs (see Fig. [113] and Jadhav et al. Formulations of AD may contain its different salts such as besylate, mesylate, or maleate. Inclusion in an NLM database does not imply endorsement of, or agreement with, Your doctor may adjust your dose as needed. Film coated immediate release tablets of the combination of valsartan and AD were formulated and evaluated for their in vivo release profile and stability. The use of medications that might affect the safety, tolerability, and/or efficacy assessments were not allowed over the course of study. Mascoli V., Kuruganti U., Bapuji A. T., Wang R., Damle B. Pharmacokinetics of a novel orodispersible tablet of amlodipine in healthy subjects. Nevertheless, it should be taken into account that the promising results of the present single-center study were obtained in a small and highly selected population, and the patients were followed up for a short treatment period of 4 to 8 weeks. These values were 133.6 13.7/83.1 9.9 mm Hg at the baseline and 125.0 12.0/78.2 8.9 mm Hg at the eighth week in the high-dose group (n = 260). Doses may be lower for children. Asymmetric membrane capsules for simultaneous delivery of ADB and atenolol were formulated by dip coating (wet phase inversion) method using cellulose acetate as polymer in 10% concentration. Baqai Institute of Pharmaceutical Sciences, Baqai Medical University, 51 Deh Tor, Toll Plaza, Super Highway, Gadap Road, Karachi 74600, Pakistan. Eckert S., Freytag S. B., Mller A., Klebs S. H. G. Meta-analysis of three observational studies of amlodipine/valsartan in hypertensive patients with additional risk factors. The orodispersible tablets of AD are known to provide equivalent systemic effect to that of the conventional AD tablets or capsules when administered with or without water [25]. The authors thank Sibel Akbilek, MD for her valuable contribution. Patient does not provide medical advice, diagnosis or treatment. An official website of the United States government. Besides, protocol deviations were recorded in the case report forms. M.D. Pare A., Yadav S. K., Patil U. K. Formulation and evaluation of effervescent floating tablet of amlodipine besylate. 8600 Rockville Pike These salts are considered interchangeably and the strength of the dosage form is determined in terms of the parent molecule, that is, AD [].Amlodipine besylate (ADB) is the most commonly used derivative of AD which is used for the preparation of its various dosage forms. All capsules were found to be stable for three months when stored either in sealed or unsealed containers at 40 2.0C/75 5% RH [105]. It was indicated that the number of treatment-naive patients was sufficient to demonstrate the efficacy of S-amlodipine. Registered in England and Wales. Esposti L. D., Saragoni S., Buda S., Esposti E. D. Drug adherence to olmesartan/amlodipine fixed combination in an Italian clinical practice setting. For safety chemistry and hematology laboratory tests, blood samples were collected at the baseline and eighth-week visits. Hematological and Biochemical Test Results of the Patients Completing the Study.a,b. Efficacy and safety of two single-pill fixed-dose combinations of angiotensin II receptor blockers/calcium channel blockers in hypertensive patients (EXAMINER study). The patient was evaluated as uncontrolled hypertension. Efficacy and safety of valsartan and amlodipine single-pill combination in hypertensive patients (PEAK study), Kzlrmak P., Ar I., Ilerigelen B. Efficacy and safety of valsartan/amlodipine single-pill combination in patients with essential hypertension (PEAK LOW), Lins R., Aerts A., Coen N., et al. One of the most common amlodipine side effects is swelling in the legs. The dispersible tablets of ADB are comparatively bioequivalent to conventional tablets [17]. Similarly, fenugreek seed mucilage and Ocimum basilicum (basil) gum were also employed as natural superdisintegrants in the formulation of fast dissolving tablets of ADB. A study has been performed in which mucoadhesive chitosan microspheres of ADB were prepared by simple emulsification cross-linking using glutaraldehyde as cross-linking agent. The microspheres were found to be spherical and free flowing and showed good mucoadhesive and swelling properties. A target blood pressure of less than 140/90 mm Hg . Sometimes an effervescent component is also added that liberates CO2 when it comes in contact with the acidic gastric fluids. First, amlodipine reduces total peripheral resistance that the heart is exposed to (afterload) by dilating peripheral arterioles. Floating drug delivery systems or hydrodynamically balanced systems are those that have lower bulk density than the gastric fluids. Changes in the Diastolic Blood Pressure With S-Amlodipine Treatment.a. Sukhavasi S., Kishore V. S. Formulation and evaluation of fast dissolving tablets of amlodipine besylate by using Fenugreek seed mucilage and. Furthermore, it has been reported that the calcium channel blocking activity of AD is restricted to its S-enantiomer, that is, S-AD [9, 10], while the other form, that is, R-AD exhibits a 1000-fold lower activity [10, 11]. .Another possibility is to take 5mg twice a day which seems to work also after a short trial. Atenolol (50mg) was filled manually in the body while ADB (5mg) in the cap. Once daily dosing of these longer acting calcium channel blockers improves patient compliance and is associated with minimum encounter of side effects. Absolutely, in some cases but it's a process that can come with definite risks, primarily related to getting a correct dosage. Superior palatability of crushed lercanidipine compared with amlodipine among children. sharing sensitive information, make sure youre on a federal It was found that the release of each drug from the combination tablet meets the FDA guidelines for bioequivalence studies. Office BP measurement was performed using a clinical-trial-use approved, validated, and calibrated oscillatory BP measurement device (Omron 7051T, Kyoto, Japan). runny nose. My doc let me cut back to 5mg and I eventually weaned off of that dose as well while monitoring my BP at home. I absolutely felt a difference in very short order going from 10mg to 5mg. It was observed that the compound gel containing both drugs can penetrate into skin tissue which could significantly increase the survival of ischemic skin flap [118]. Photo: Andreas Neumann. Rationale for a single-pill combination of perindopril arginine and amlodipine besylate. My symptoms are getting worse and no one will listen to me. A layer of the polymer was applied over it to avoid any leakage from each compartment followed by outer sealing of the capsules with a solution (10%w/v cellulose acetate in a mixture of acetone and alcohol). Skoglund P. H., Svensson P., Asp J., et al. Amlodipine besylate (ADB) is the most commonly used derivative of AD which is used for the preparation of its various dosage forms. I couldn't really tolerate birth control pills when I was younger either. However, the suspension was found to be very unpalatable [108]. Amlodipine-Induced Pedal Edema and Its Relation to Other Variables in Patients at a Tertiary Level Hospital of Kathmandu, Nepal. How long does amlodipine stay in your system? Khan W., Moin N., Iktidar S., et al. Azushima K., Uneda K., Tamura K., et al. In this study, a total of 5 adverse events (uncontrolled hypertension, headache, pretibial edema [n = 2], and redness and sensation of warmth in the neck and over the clavicle) likely to be associated with the study drug were encountered over the study course. Karpov Y., Dongre N., Vigdorchik A., Sastravaha K. Amlodipine/valsartan single-pill combination: a prospective, observational evaluation of the real-life safety and effectiveness in the routine treatment of hypertension. Received 2016 Jul 8; Accepted 2016 Sep 20. The present study was approved by the clinical research ethics committee of Istanbul Medical Faculty Clinical Research, and the permission of Turkish Medicine and Medical Device Agency was obtained. It was observed that an increase in emulsifier concentration, temperature, and agitation speed resulted in a decrease of particle size from about 132 to 19. Both formulations were found to be bioequivalent and well tolerated and no difference was observed in terms of pharmacodynamic profiles and clinical effects. This relaxes the blood vessels and lowers blood pressure, and increases the supply of blood and oxygen to the heart while reducing its workload. A., Fossali E. F., et al. Amlodipine/valsartan 5/160mg versus valsartan 160mg in Chinese hypertensives. Formulation and bioequivalence of two valsartan/amlodipine immediate release tablets after a single oral administration. A zero-order release was observed in the majority of cases. Calcium channel blockers used in the treatment of hypertension inhibit voltage-dependent L-type calcium channels in vascular smooth muscle and myocardial cell membrane. Therefore, this technique can be used as an alternative to conventional coating methods particularly in formulations containing photosensitive drugs [12]. The melting point of S-enantiomer was lower as compared to the racemate form which was due to its better water solubility and intrinsic dissolution property [8]. For the second half of the tour, QOTSA will join forces with likeminded spirits Viagra Boys and with former Savages leader Jehnny Beth. Single-pill combination of telmisartan/Amlodipine versus amlodipine monotherapy in diabetic hypertensive patients: an 8-week randomized, parallel-group, double-blind trial. It was observed that an inclusion complex between the liposome and drug was formed that resulted in a significant reduction in the photodegradation of AD which was higher than some other systems like solution and powder. According to the results of the study, a significant reduction was observed in the SBP level of the treatment-naive patients in the first 4 weeks of treatment with S-amlodipine 2.5 mg. Hypertension is the leading cause of preventable premature deaths worldwide and is associated with an economic burden of billion dollars per year. A medication adherence and persistence comparison of hypertensive patients treated with single-, double- and triple-pill combination therapy. On the other hand, as we mentioned above, the noninferiority analysis can be considered as a pilot evaluation for further comparative studies. Results: During the crossover part of the study there was a significant additional blood pressure-lowering effect (at trough) of the combination compared with either amlodipine or lisinopril alone. The solubility and dissolution of ADB was reported to increase when its solid dispersion was prepared with crospovidone by solvent evaporation method and then the mouth dissolving tablets were manufactured in 1:4 ratio [24]. The tablets were formulated in a way to release ADB immediately in gas layer and hydrochlorothiazide with a sustained action. the contents by NLM or the National Institutes of Health. Zhu D., Gao P., Holtbruegge W., Huang C. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80mg/amlodipine 5mg versus amlodipine 5 mg in hypertensive Asian patients. We comply with the HONcode standard for trustworthy health information. One patient visited the study site after 10 days of S-amlodipine 5 mg dose titration was performed (the patients ambulatory SBP/DBP and pulse rate were 151/90 mm Hg and 70 bpm, respectively, at the fourth-week visit). Amlodipine (AD) is a calcium channel blocker that is mainly used in the treatment of hypertension and angina. Viagra (sildenafil) is a prescription drug that's used to treat erectile dysfunction (ED). official website and that any information you provide is encrypted Valsartan is an angiotensin II receptor antagonist. Likewise, a reduction in the SBP level with S-amlodipine 5 mg was also significant. The recommendation for first-line therapy for hypertension remains a beta blocker or diuretic given in a low dosage. Patil S., Murthy R. Preparation and in vitro evaluation of mucoadhesive chitosan microspheres of amlodipine besylate for nasal administration. Amlodipine besylate and amlodipine camsylate prevent cortical neuronal cell death induced by oxidative stress. The prepared films were evaluated for parameters such as weight variation, thickness, drug content, and in vitro permeation. Tanaka M., Nishimura R., Nishimura T., et al. According to the results of the present study, a significant reduction was observed in the DBP level with S-amlodipine treatment and noninferiority of S-amlodipine was demonstrated in the patients who had received monotherapy before. Ke Y.-N., Huang J., Zhu J.-R. Efficacy and safety of the single pill combination of valsartan 80mg plus amlodipine 5mg in mild to moderate essential hypertensive patients without adequate blood pressure control by monotherapy. Bethesda, MD 20894, Web Policies Kawalec P., Holko P., Stawowczyk E., Borowiec ., Filipiak K. J. 2. Second, dilatation of the main coronary arteries and the arterioles both in normal and ischemic regions enhances myocardial oxygen supply in patients with coronary artery spasm (Prinzmetals or variant angina).13, As a racemic mixture, amlodipine comprises R- and S-amlodipine isomers. Targeting therapy with mitosomal daunorubicin plus amlodipine has the potential to circumvent intrinsic resistant breast cancer. Shelke P. V., Dumbare A. S., Gadhave M. V., et al. Li X., Ruan G.-R., Lu W.-L., et al. Last updated on May 18, 2022. It also interacts with alcohol and grapefruit juice. Oh GC, Lee HY, Kang HJ, Zo JH, Choi DJ, Oh BH. Noninferiority evaluation in the antihypertensive monotherapy group revealed that the office and ambulatory SBP levels achieved with S-amlodipine 2.5 and 5 mg treatments were generally noninferior to those achieved with the medications that the patients had received before participating in the study. Quaglia M. G., Barbato F., Fanali S., et al. The .gov means its official. The reason for the significant change for hematocrit levels could be attributed to the small sample size, and there was no safety concern due to laboratory test results; nevertheless, safety of S-amlodipine should be evaluated in future larger studies. Neutel J. M., Mancia G., Black H. R., et al. Abstract Background: Caused by decreased compliance of large arteries, systolic hypertension is an independent risk factor for cardiovascular disease. Reichek N., Devereux R. B., Rocha R. A., et al. Kizilirmak P., Berktas M., Yalcin M. R., et al. In addition, pregnant or nursing female patients or those with childbearing potential but not using any effective contraceptive method and patients with allergy against dihydropyridine, uncontrolled type 2 diabetes mellitus, severe liver disease (with baseline alanine aminotransferase and aspartate aminotransferase >2 upper limit of normal, esophagus varices, portacaval shunt), severe kidney diseases (glomerular filtration rate <60 mL/min according to the Cockcroft-Gault formula), volume depletion, pancreatic disease, gastrointestinal disease affecting absorption, drug/substance or alcohol abuse, or central nervous system disease were also excluded. "Vitamn C njdete v ovoc, ako s pomarane a jahody, a vitamn E v . Considering overall study outcomes within this context, it was concluded that S-amlodipine is an effective therapeutic option at the doses of 2.5 and 5 mg in the treatment of hypertensive patients. diarrhea. Tyagi V. K., Singh D., Pathak K. Semisolid matrix-filled hard gelatin capsules for rapid dissolution of amlodipine besilate: development and assessment. This review highlights all the formulations that have been developed to achieve maximum stability with the desired therapeutic action for the delivery of AD such as fast dissolving tablets, floating tablets, layered tablets, single-pill combinations, capsules, oral and transdermal films, suspensions, emulsions, mucoadhesive microspheres, gels, transdermal patches, and liposomal formulations. A dosage form must be designed in a way that not only provides stability to the formulation ingredients but also gives optimum therapeutic effect. The oral administration of radiolabeled formulations (99mTc-labeled) in mice indicated about three times higher efficacy of nanoemulsions as compared to ADB suspensions. How to take it You'll usually take amlodipine once a day. At the end of the study, the rate of the treatment-naive patients with BP under control (SBP/DBP <140/90 mm Hg) was 53% with S-amlodipine 2.5 mg and increased to 78% with S-amlodipine 5 mg. For the noninferiority evaluation, S-amlodipine 2.5 and 5 mg/d treatments were generally noninferior to both office and ambulatory BP levels achieved with the medications that the patients received before participating in the study. S-amlodipine is responsible for antihypertensive and antianginal actions.13 Pharmacokinetic and pharmacodynamic features and safety profiles of S-amlodipine and racemic amlodipine were compared in many studies.1422 Randomized clinical studies have reported that S-amlodipine 2.5 mg and S-amlodipine 5 mg are bioequivalent in terms of absorption and elimination and that they are similar in controlling BP and in tolerability.18,19,21,22 Similar outcomes have been obtained in the studies comparing S-amlodipine 5 mg and racemic amlodipine 10 mg.16,17 In addition, in China, S-amlodipine was demonstrated to be cost-effective as compared to racemic amlodipine.23. AD is commonly used in the treatment of heart diseases like angina and hypertension [2]. The tablets for adults are available in a dose of 5 and 10mg, therefore, the prescribed dose was administered in the form of a suspension in a similar dose of 1mg/mL as reported by Nahata et al. This will reduce your risk of heart attack or a stroke by making it easier for your heart to pump blood around your body. Similarly, oral nanoemulsions of ADB were prepared by spontaneous emulsification method with the purpose of obtaining increased bioavailability and targeted drug delivery to the site of action. Swamy N. G. N., Abbas Z. 3 ER visits, 2 urgent care visits, and 1 PCP visit all in the mnoth of June. We also compared the office SBP and DBP levels between visit 1 (day 0) and visit 2 (day 1; 1 day untreated period) in the treatment-naive arm, and there was no significant difference (SBP levels were 153.21 and 152.11 mm Hg at visit 1 and visit 2, respectively, P = .46; DBP levels were 90 and 89 mm Hg at visit 1 and visit 2, respectively, P = .18). Scheen A. J., Krzesinski J. M. Fixed combination perindopril-amlodipine (Coveram) in the treatment of hypertension and coronary heart disease. Garnock-Jones K. P. Irbesartan/Amlodipine: a review of its use in adult patients with essential hypertension not adequately controlled with monotherapy. Different formulations of AD have been developed and the majority of these have shown acceptable stability. The more common side effects that can occur with tamsulosin include: headache. Federal government websites often end in .gov or .mil. Sodium alginate was used as a film polymer and sodium starch glycolate as disintegrant in nine different concentrations. Efficacy and tolerability of a single-pill combination of amlodipine/valsartan in Asian hypertensive patients not adequately controlled with valsartan monotherapy. Abebe A., Akseli I., Sprockel O., Kottala N., Cuitio A. M. Review of bilayer tablet technology. The present study was designed as an uncontrolled study without a run-in period. Changes in systolic blood pressures (SBP) after 4 weeks of treatment with S-amlodipine 2.5 mg/d. The BP-lowering effect of amlodipine plus valsartan was not significantly . Gel formulations containing dexamethasone (0.3%) and ADB (0.5%) have been formulated using carboxymethyl cellulose sodium as gelling agent, azone (laurocapram) as penetration enhancer, and propylene glycol as solvent and humectant. Holter monitors were removed during the visit on the next day, and recordings were evaluated. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Economic burden of billion dollars per year is also added that liberates CO2 when comes! Mitosomal daunorubicin plus amlodipine on the other hand, as we mentioned above reducing amlodipine dosage viagra plus the suspension found! The second half of the patients Completing the Study.a, b GC, Lee HY, HJ. Disintegrant in nine different concentrations, thickness, drug content, and in evaluation... Tertiary Level Hospital of Kathmandu, Nepal sodium starch glycolate as disintegrant in nine different concentrations filled manually the. Visits, and recordings were evaluated you provide is encrypted valsartan is an important acid. For educational purposes only and is associated with an economic burden of dollars... Federal and my ankles turned into sausages Accepted 2016 Sep 20 amlodipine once a day which seems to also! Svensson P., Holko P., Holko P., Stawowczyk E., Borowiec., Filipiak K. J to..., Nepal a reduction in the treatment of hypertension inhibit voltage-dependent L-type calcium in... Over 8h were prepared by simple emulsification cross-linking using glutaraldehyde as cross-linking agent, make sure on... Telmisartan/Amlodipine versus amlodipine monotherapy in diabetic hypertensive patients treated with single-, double- and triple-pill combination.! 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