Disinvestment. Ana Luísa Caires de Souza
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Disinvestment. Ana Luísa Caires de Souza

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SIX YEARS OF GLARGINE FINANCED BY THE MINAS GERAIS STATE GOVERNMENT, BRAZIL: SHOULD THE GOVERNMENT DISINVEST?

SIX YEARS OF GLARGINE FINANCED BY THE MINAS GERAIS STATE GOVERNMENT, BRAZIL: SHOULD THE GOVERNMENT DISINVEST?

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  • Rounded corner rectangle tabs with inset pictures(Advanced)To reproduce the top rectangle (olive-green, “label one”) with text effects on this slide, do the following:On the Home tab, in the Slides group, click Layout, and then click Blank.On the Home tab, in the Drawing group, click Shapes, and then under Rectangles, click Rounded Diagonal Corner Rectangle (ninth option from the left). On the slide, drag to draw a rectangle.On the Home tab, in the bottom right corner of the Drawing group, click the Format Shape dialog box launcher. In the Format Shape dialog box, click Fill in the left pane, select Gradient fill in the right pane, and then do the following:In the Type list, select Linear.Click the button next to Direction, and then click Linear Down (first row, second option from the left).Under Gradient stops, click Add or Remove until two stops appear in the drop-down list.Also under Gradient stops, customize the gradient stops that you added as follows:Select Stop 1 from the list, and then do the following:In the Stop position box, enter 32%.Click the button next to Color, and then under Theme Colors click White, Background 1 (first row, first option from the left).Select Stop 2 from the list, and then do the following:In the Stop position box, enter 100%.Click the button next to Color, and then under Theme Colors click Olive Green, Accent 3, Lighter 60% (third row, seventh option from the left).Also in the Format Shape dialog box, click Line Color in the left pane, select Gradient line in the right pane, and then do the following:In the Type list, select Linear.Click the button next to Direction, and then click Linear Up (second row, second option from the left). Under Gradient stops, click Add or Remove until two stops appear in the drop-down list.Also under Gradient stops, customize the gradient stops that you added as follows:Select Stop 1 from the list, and then do the following:In the Stop position box, enter 0%.Click the button next to Color, and then under Theme Colors click White, Background 1 (first row, first option from the left).Select Stop 2 from the list, and then do the following:In the Stop position box, enter 100%.Click the button next to Color, and then under Theme Colors click White, Background 1, Darker 25% (fourth row, first option from the left).Also in the Format Shape dialog box, click Line Style in the left pane. In the Line Style pane, in the Width box, enter 1 pt. On the Home tab, in the Drawing group, click Shape Effects, point to Glow, and then do the following:Under Glow Variations, select any option in the first row (5 pt glow options). Point to More Glow Colors, and then under Theme Colors click White, Background 1, Darker 25% (fourth row, first option from the left). On the slide, right-click the rectangle and then click Edit Text. Enter text in the text box and select the text. On the Home tab, in the Font group, select Gill Sans MT from the Font list and then select 24 from the Font Size list.On the Home tab, in the Paragraph group, click Align Text Left to align the text left within the rectangle.Under Drawing Tools, on the Format tab, in the WordArt Styles group, click the arrow next to Text Fill, click More Fill Colors, and then in the Colors dialog box, on the Custom tab, enter values for Red: 127, Green: 127, and Blue: 127.Select the rectangle. On the Home tab, in the bottom-right corner of the Drawing group, click the Format Shapes dialog box launcher. In the Format Shapes dialog box, click Text Box in the left pane. In the right pane, under Internal margin, enter 1” in the Left box to increase the left margin in the rectangle to accommodate the embossed picture. Under Drawing Tools, on the Format tab, in the Size group, do the following:In the Shape Height box, enter 0.92”.In the Shape Width box, enter 4.5”.To reproduce the olive-green embossed picture for the top rectangle on this slide, do the following:On the Home tab, in the Drawing group, click Shapes, and then under Rectangles, click Rounded Diagonal Corner Rectangle (ninth option from the left). On the slide, drag to draw a rectangle.On the Home tab, in the bottom right corner of the Drawing group, click the Format Shape dialog box launcher. In the Format Shape dialog box, click Fill in the left pane, select Picture or texture fill, and then under Insert from click File. In the Insert Picture dialog box, select a picture and then click Insert. Also in the Format Shape dialog box, click Line Color in the left pane. In the Line Color pane, select No line. Also in the Format Shape dialog box, click Picture in the left pane, click the button next to Recolor, and then under Light Variations click Accent color 3 Light (fourth option from the left).Also in the Format Shape dialog box, click Shadow in the left pane, and then do the following in the right pane:Click the button next to Preset, and then under Inner click Inside Diagonal Top Left (first row, first option from the left).In the Transparency box, enter 65%. Under Picture Tools, on the Format tab, in the bottom right corner of the Size group, click the Size and Position dialog box launcher. In the Size and Position dialog box, on the Size tab, do the following:Under Scale, select the Lock aspect ratio check box.Under Size and rotate, in the Height box, enter 0.75”. (Under Size and rotate, in the Width box, 0.75” will appear automatically.)Drag the picture onto the left side of the rectangle. Press and hold CTRL and select the picture and the rectangle. On the Home tab, in the Drawing group, click Arrange, point to Align, and then click Align Middle. To reproduce the other shapes on this slide, do the following:Press and hold CTRL and select the picture and the rectangle. On the Home tab, in the Drawing group, click Arrange, and then click Group. On the Home tab, in the Clipboard group, click the arrow under Paste, and then click Duplicate. Repeat the process until there is a total of four groups of shapes.Drag the groups so that they are distributed vertically on the slide. Press and hold CTRL and select all four groups. On the Home tab, in the Drawing group, click Arrange, and then do the following:Point to Align, and then click Align Center. Point to Align, and then click Distribute Vertically. Click Ungroup. To change the color and text for the duplicate rectangles (second, third, and fourth from the top), do the following:Select the rectangle that you would like to recolor.Under Drawing Tools, on the Format tab, in the Shape Styles group, click the arrow next to Shape Fill, point to Gradient, and then click More Gradients.In the Format Shape dialog box, click Fill in the left pane, select Gradient fill in the right pane, and then do the following:For the second rectangle from the top, under Gradient stops, select Stop 2 from the drop-down list, click the button next to Color, and then under Theme Colors click Orange, Accent 6, Lighter 60% (third row, tenth option from the left). For the third rectangle from the top, under Gradient stops, select Stop 2 from the drop-down list, click the button next to Color, and then under Theme Colors click Aqua, Accent 5, Lighter 60% (third row, ninth option from the left).For the fourth rectangle from the top, under Gradient stops, select Stop 2 from the drop-down list, click the button next to Color, and then under Theme Colors click Blue, Accent 1, Lighter 60% (third row, fifth option from the left).To change the text on the duplicate rectangles, click in each text box and edit the text. To change the picture on the duplicate rectangles (second, third, and fourth from the top), do the following:Right-click the second picture from the top, and then click Format Picture. In the Format Picture dialog box, click Fill in the left pane, and then under Insert from click File. In the Insert Picture dialog box, select a picture, and then click Insert.Repeat the process for the third and fourth rectangles from the top. To change the color for the duplicate pictures (second, third, and fourth from the top), do the following:Select the picture that you would like to recolor.Under Picture Tools, on the Format tab, in the Adjust group, click the arrow next to Recolor, and then do the following:For the second picture from the top, under Light Variations, click Accent color 6 Light (seventh option from the left).For the third picture from the top, under Light Variations, click Accent color 5 Light (sixth option from the left).For the fourth picture from the top, under Light Variations, click Accent color 1 Light (second option from the left).To reproduce the background on this slide, do the following:Right-click the slide background area, and then click Format Background. In the Format Background dialog box, click Fill in the left pane, select Gradient fill in the right pane, and then do the following:In the Type list, select Radial.Click the button next to Direction, and then click From Center (third option from the left).Under Gradient stops, click Add or Remove until two stops appear in the drop-down list.Also under Gradient stops, customize the gradient stops that you added as follows:Select Stop 1 from the list, and then do the following:In the Stop position box, enter 0%.Click the button next to Color, and then under Theme Colors click White, Background 1 (first row, first option from the left).Select Stop 2 from the list, and then do the following:In the Stop position box, enter 100%.Click the button next to Color, and then under Theme Colors click White, Background 1, Darker 15% (third row, first option from the left).
  • Rounded corner rectangle tabs with inset pictures(Advanced)To reproduce the top rectangle (olive-green, “label one”) with text effects on this slide, do the following:On the Home tab, in the Slides group, click Layout, and then click Blank.On the Home tab, in the Drawing group, click Shapes, and then under Rectangles, click Rounded Diagonal Corner Rectangle (ninth option from the left). On the slide, drag to draw a rectangle.On the Home tab, in the bottom right corner of the Drawing group, click the Format Shape dialog box launcher. In the Format Shape dialog box, click Fill in the left pane, select Gradient fill in the right pane, and then do the following:In the Type list, select Linear.Click the button next to Direction, and then click Linear Down (first row, second option from the left).Under Gradient stops, click Add or Remove until two stops appear in the drop-down list.Also under Gradient stops, customize the gradient stops that you added as follows:Select Stop 1 from the list, and then do the following:In the Stop position box, enter 32%.Click the button next to Color, and then under Theme Colors click White, Background 1 (first row, first option from the left).Select Stop 2 from the list, and then do the following:In the Stop position box, enter 100%.Click the button next to Color, and then under Theme Colors click Olive Green, Accent 3, Lighter 60% (third row, seventh option from the left).Also in the Format Shape dialog box, click Line Color in the left pane, select Gradient line in the right pane, and then do the following:In the Type list, select Linear.Click the button next to Direction, and then click Linear Up (second row, second option from the left). Under Gradient stops, click Add or Remove until two stops appear in the drop-down list.Also under Gradient stops, customize the gradient stops that you added as follows:Select Stop 1 from the list, and then do the following:In the Stop position box, enter 0%.Click the button next to Color, and then under Theme Colors click White, Background 1 (first row, first option from the left).Select Stop 2 from the list, and then do the following:In the Stop position box, enter 100%.Click the button next to Color, and then under Theme Colors click White, Background 1, Darker 25% (fourth row, first option from the left).Also in the Format Shape dialog box, click Line Style in the left pane. In the Line Style pane, in the Width box, enter 1 pt. On the Home tab, in the Drawing group, click Shape Effects, point to Glow, and then do the following:Under Glow Variations, select any option in the first row (5 pt glow options). Point to More Glow Colors, and then under Theme Colors click White, Background 1, Darker 25% (fourth row, first option from the left). On the slide, right-click the rectangle and then click Edit Text. Enter text in the text box and select the text. On the Home tab, in the Font group, select Gill Sans MT from the Font list and then select 24 from the Font Size list.On the Home tab, in the Paragraph group, click Align Text Left to align the text left within the rectangle.Under Drawing Tools, on the Format tab, in the WordArt Styles group, click the arrow next to Text Fill, click More Fill Colors, and then in the Colors dialog box, on the Custom tab, enter values for Red: 127, Green: 127, and Blue: 127.Select the rectangle. On the Home tab, in the bottom-right corner of the Drawing group, click the Format Shapes dialog box launcher. In the Format Shapes dialog box, click Text Box in the left pane. In the right pane, under Internal margin, enter 1” in the Left box to increase the left margin in the rectangle to accommodate the embossed picture. Under Drawing Tools, on the Format tab, in the Size group, do the following:In the Shape Height box, enter 0.92”.In the Shape Width box, enter 4.5”.To reproduce the olive-green embossed picture for the top rectangle on this slide, do the following:On the Home tab, in the Drawing group, click Shapes, and then under Rectangles, click Rounded Diagonal Corner Rectangle (ninth option from the left). On the slide, drag to draw a rectangle.On the Home tab, in the bottom right corner of the Drawing group, click the Format Shape dialog box launcher. In the Format Shape dialog box, click Fill in the left pane, select Picture or texture fill, and then under Insert from click File. In the Insert Picture dialog box, select a picture and then click Insert. Also in the Format Shape dialog box, click Line Color in the left pane. In the Line Color pane, select No line. Also in the Format Shape dialog box, click Picture in the left pane, click the button next to Recolor, and then under Light Variations click Accent color 3 Light (fourth option from the left).Also in the Format Shape dialog box, click Shadow in the left pane, and then do the following in the right pane:Click the button next to Preset, and then under Inner click Inside Diagonal Top Left (first row, first option from the left).In the Transparency box, enter 65%. Under Picture Tools, on the Format tab, in the bottom right corner of the Size group, click the Size and Position dialog box launcher. In the Size and Position dialog box, on the Size tab, do the following:Under Scale, select the Lock aspect ratio check box.Under Size and rotate, in the Height box, enter 0.75”. (Under Size and rotate, in the Width box, 0.75” will appear automatically.)Drag the picture onto the left side of the rectangle. Press and hold CTRL and select the picture and the rectangle. On the Home tab, in the Drawing group, click Arrange, point to Align, and then click Align Middle. To reproduce the other shapes on this slide, do the following:Press and hold CTRL and select the picture and the rectangle. On the Home tab, in the Drawing group, click Arrange, and then click Group. On the Home tab, in the Clipboard group, click the arrow under Paste, and then click Duplicate. Repeat the process until there is a total of four groups of shapes.Drag the groups so that they are distributed vertically on the slide. Press and hold CTRL and select all four groups. On the Home tab, in the Drawing group, click Arrange, and then do the following:Point to Align, and then click Align Center. Point to Align, and then click Distribute Vertically. Click Ungroup. To change the color and text for the duplicate rectangles (second, third, and fourth from the top), do the following:Select the rectangle that you would like to recolor.Under Drawing Tools, on the Format tab, in the Shape Styles group, click the arrow next to Shape Fill, point to Gradient, and then click More Gradients.In the Format Shape dialog box, click Fill in the left pane, select Gradient fill in the right pane, and then do the following:For the second rectangle from the top, under Gradient stops, select Stop 2 from the drop-down list, click the button next to Color, and then under Theme Colors click Orange, Accent 6, Lighter 60% (third row, tenth option from the left). For the third rectangle from the top, under Gradient stops, select Stop 2 from the drop-down list, click the button next to Color, and then under Theme Colors click Aqua, Accent 5, Lighter 60% (third row, ninth option from the left).For the fourth rectangle from the top, under Gradient stops, select Stop 2 from the drop-down list, click the button next to Color, and then under Theme Colors click Blue, Accent 1, Lighter 60% (third row, fifth option from the left).To change the text on the duplicate rectangles, click in each text box and edit the text. To change the picture on the duplicate rectangles (second, third, and fourth from the top), do the following:Right-click the second picture from the top, and then click Format Picture. In the Format Picture dialog box, click Fill in the left pane, and then under Insert from click File. In the Insert Picture dialog box, select a picture, and then click Insert.Repeat the process for the third and fourth rectangles from the top. To change the color for the duplicate pictures (second, third, and fourth from the top), do the following:Select the picture that you would like to recolor.Under Picture Tools, on the Format tab, in the Adjust group, click the arrow next to Recolor, and then do the following:For the second picture from the top, under Light Variations, click Accent color 6 Light (seventh option from the left).For the third picture from the top, under Light Variations, click Accent color 5 Light (sixth option from the left).For the fourth picture from the top, under Light Variations, click Accent color 1 Light (second option from the left).To reproduce the background on this slide, do the following:Right-click the slide background area, and then click Format Background. In the Format Background dialog box, click Fill in the left pane, select Gradient fill in the right pane, and then do the following:In the Type list, select Radial.Click the button next to Direction, and then click From Center (third option from the left).Under Gradient stops, click Add or Remove until two stops appear in the drop-down list.Also under Gradient stops, customize the gradient stops that you added as follows:Select Stop 1 from the list, and then do the following:In the Stop position box, enter 0%.Click the button next to Color, and then under Theme Colors click White, Background 1 (first row, first option from the left).Select Stop 2 from the list, and then do the following:In the Stop position box, enter 100%.Click the button next to Color, and then under Theme Colors click White, Background 1, Darker 15% (third row, first option from the left).

Disinvestment. Ana Luísa Caires de Souza Disinvestment. Ana Luísa Caires de Souza Presentation Transcript

  • Authors:Ana Luísa Caires de SouzaFrancisco de Assis AcurcioAugusto Afonso Guerra JúniorRenata Cristina Rezende Macedo do NascimentoLeonardo Maurício Diniz
  •  Insulin analogues: safety, efficacy and comfort Glargine • 2000 EMEA • 2003 ANVISA Expectation Hypoglycaemic episodes Marketing Judicialization Medicines List Comfort strategy SES/MG/2005 Administrative requests: 2,632 Expenses of Minas Gerais State Treasury with glargine grew an average of 291% per year, reaching almost USD 6 million/2011.
  • Glargine expenses in Minas Gerais State, Brazil (2007-2011) Costs: Glargine > 536% NPH 2009: Glargine and cancer Systematic Review: Efficacy and safety of glargine in T1DM.
  • OBJECTIVETo assess the efficacy and the safety of glargine in order to evaluate thepertinence of maintenance the drug on the list of SUS from Minas GeraisState in Brazil.
  • Search  MEDLINE;  Latin American and Caribbean Centre on Health Sciences Information;  Cochrane Controlled Trials Databases ;  National Health Service (NHS) Centre for Reviews and Dissemination.Software  Reference ManagerKeywords  Portuguese, English, Spanish.Health Condition Intervention Study TypeT1DM Glargine insulin, NPH insulin, Regular EfficacyGlycated hemoglobin insulin, Animal NPH EffectivenessHypoglycemia insulin, Recombinant NPH Cost effectivenessDiabetes complications insulin, Animal regular insulin, Recombinant regular insulin
  • Inclusion Criteria  Intervention: glargine monotherapy or combination regimens with other insulins. Exclusion Criterias  languages other than English, Portuguese or Spanish;  not performed in human;  unrelated to T1DM;  Not present at least one of the outcome measures of efficacy or safety.Systematic Reviews of Clinical Trials identified in the search process were used forcomparison and discussion of results.
  • Titles and abstracts analysis  2 reviewers;  Discordant: 3rd reviewer.Outcomes measure  blood concentration of glycated hemoglobin;  measures of glucose;  episodes of hypoglycemia;  reduction of microvascular and macrovascular events;  adverse effects.Assessment of risk of bias  Modified Jadad Scale (JADAD, 1996)
  • Schematic presentation of the articles included and excluded in the systematic review Studies initially identified in the search: 803Excluded abstracts: 79 Excluded titles: 666Reasons ReasonsNot performed in humans: 6 Not performed in humans: 9Not related to T1DM: 4 Not related to T1DM: 108 Included titles: 137Not presenting comparative Not presenting comparativeresults regarding the efficacy/ results regarding the efficacy/effectiveness of the studied drug: effectiveness of the studied drug:64 546Not presenting at least one of the Not presenting at least one of theoutcome measures of outcome measures ofefficacy and/or efficacy and/or safety consideration:safety consideration: 5 3 Studies included in the final review: 58 Observational studies: 50 Clinical trials: 8
  • Modified Jadad Scale Intention to Treat Randomisation Randomisation Randomisation Inappropriate Appropriate Appropriate Withdrawal Dropout/ Analysis Blinding Blinding Score ArticleRosenstock et al., 200017 1 0 0 0 0 1 1 3Raskin et al., 200015 1 1 0 0 0 1 1 4Pieber et al., 200013 1 0 0 0 0 0 0 1Schober et al., 200218 1 0 0 0 0 1 1 3Doyle et al., 20045 1 1 0 0 0 1 1 4Chatterjee et al., 20072 1 1 0 0 0 1 0 3Chase et al., 20081 1 0 0 0 0 1 1 3White et al., 200922 1 0 0 0 0 1 0 2  Mean score: 2,87  None estudy with scored 5-6  No double-blind study  Conflict of interest: 7 trials
  • Characteristics of the selected clinical trials 7 Glargine x NPH, 1 Glargine x Aspart , 0 Glargine x Detemir; Median participants: 168 (<32 e >619); Median follow-up: 4 months (1 month, 2 years); Basal therapy: glargine 1x/day x NPH 1x or 2x/day; Prandial component: lispro, aspart or regular.
  • Characteristics of participants and interventions in selected clinical trials 1591 participants Gender • female: 56,7% Age • Minimum age: 5 years • Maximum age: 80 years Associated comorbidities were investigated but were not discussed in the selected studies. BMI: there were no changes (Chase et al., 2008; Doyle et al., 2004; and Chatterjee et al., 2007)
  • Advantages in the reduction of hypoglycemia and Glycated Hemoglobin (HbA1c) Statistically significant Statistically significant advantage in the Article advantage in the reduction reduction of episodes of of HbA1c hypoglycaemia Rosenstock et al., 200017 NPH * Raskin et al., 200015 NS NS Pieber et al., 200013 Glargine Glargine Schober et al., 200218 ** NS Doyle et al., 20045 ** Aspart Chatterjee et al., 20072 NS Glargine Chase et al., 20081 Glargine NS White et al., 200922 * NS * Not assessed in the study. NS: No statistically significant advantage found. **It was not presented p-value.
  •  The trials did not show relevant differences in the adverse effects. Chronic complications of diabetes, mitogenic effects attributed to glargine and other possible long-term undesirable effects; Cost-benefit ratio of glargine does not support its use, particularly in poor countries, although it might be indicated in specific conditions when there are sufficient resources (Gill et al, 2010). In Brazil, the cost of treating with glargine is remarkably higher than that with NPH insulin; The cost-effectiveness ratio seems to favour the use of the NPH. Manufacturer of glargine should present the Unified Health System (SUS) managers reasons justifying the higher cost of this drug, including novel evidence and more precise measurements of its cost-effectiveness and impact on quality-adjusted life years (QALYs).
  • The present systematic review did not find advantages of the treatment withglargine compared to other investigated insulin formulations when glycemiccontrol and the frequency and the severity of episodes of hypoglycemia wereanalyzed together. Furthermore, the available evidence is weak and is not enough.For these reasons, the SUS State Manager was advised to disinvest or torenegotiate the price of glargine with its manufacturer.
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  • REFERENCES9. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996 Feb;17(1):1-12.10. Jonasson JM, Ljung R, Talbäck M, Haglund B, Gudbjörnsdòttir S, Steineck G. Insulin glargine use and short-term incidence of malignancies—a population-based follow-up study in Sweden. Diabetologia. Set. 2009; 52(9):1745- 54. Epub 2009 Jul 9.11. Machado MAA, Acurcio FA, Brandão CMR, Faleiros DR, Guerra Júnior AA, Cherchiglia ML, Andrade EIG. Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil [Judicialisation of access to medicines in the State of Minas Gerais, Brazil]. Rev Saúde Pública. 2011 Jun;45(3):590-8. Epub 2011 Apr 1.12. Monami M, Marchionni N, Mannucci E. Long-acting insulin analogues vs. NPH human insulin in type 1 diabetes: a meta-analysis. Diabetes Obes Metab. Abr. 2009; 11(4):372-8.13. Pieber TR, Eugene-Jolchine I, Derobert E. Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes. The European Study Group of HOE 901 in type 1 diabetes. Diabetes Care. Fev. 2000; 23(2):157-162.14. Plank J, Siebenhofer A, Berghold A, Jeitler K, Horvath K, Mrak P, et al. Systematic Review and Meta-analysis of Short-Acting Insulin Analogues in Patients With Diabetes mellitus. Arch Intern Med. Jun. 2005; 165(12):1325- 1444.15. Raskin P, Klaff L, Bergenstal R, Halle JP, Donley D, Mecca T. A 16-week comparison of the novel insulin analog insulin glargine (HOE 901) and NPH human insulin used with insulin lispro in patients with type 1 diabetes. Diabetes Care. Nov. 2000; 23(11):1666-1671.16. Rede Brasileira de Avaliação de Tecnologia em Saúde [Brazilian Network for Health Technology Assessment]. Boletim Brasileiro de Avaliação de Tecnologias em Saúde [Brazilian Bulletin of Health Technology Assessment]. Insulina Glargina e Insulina Detemir no Controle da Diabetes Mellitus Tipo 1 (2010) [Glargine insulin and detemir insulin: the control of type 1 diabetes mellitus (2010)] http://bvsms.saude.gov.br/bvs/ct/pdf/brats2010_n13.pdf (Accessed Feb 2011).
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  • THANK YOU! Ana Luísa Cairesanaluisacaires@gmail.com