DVT prophylaxis - anticoagulant - orthopedic surgery clinical trials results meta-analysis

<h1> <a href="index.html"> <strong>DVT prophylaxis</strong> - anticoagulant </a> - orthopedic surgery trial results systematic overview and meta-analysis </h1> <h2>Main characteristics of the included studies</h2> <table> <tr> <th>Trial</th> <th>Treatments</th> <th>Patients</th> <th>Methods</th> </tr> <tr> <td> <a href="index.html"> RE-MOBILIZE (220mg), 2008 </a> <br> </td> <td> dabigatran etexilate 220 mg for 12-15 days <br>  <i>versus</i> <br> Enoxaparin 30mg SC BID after surgery for 12-15 days </td> <td> Total knee replacement </td> <td> follow-up 12-15 days, median 14d<br> n=862/876<br> Parallel groups<br> double blind <br> US, Canada, Mexico, UK </td> </tr> <tr> <td> <a href="index.html"> RE-MODEL (220mg), 2007 </a> <br> </td> <td> dabigatran etexilate 220 mg q.d. 6-10 days <br>  <i>versus</i> <br> Enoxaparin 40 mg q.d. for 6-10 days </td> <td> Total knee replacement </td> <td> follow-up 6-10 days, mean 8 days<br> n=694/699<br> <br> double blind <br> Europe, Australia, South Africa </td> </tr> <tr> <td> <a href="TRC_t6729.html"> RE-NOVATE (220mg), 2007 </a> <br> NCT00168818 </td> <td> dabigatran etexilate 220 mg q.d. for 28-35 days<br>  <i>versus</i> <br> Enoxaparin 40 mg q.d. for 23-35 days </td> <td> Total hip replacement </td> <td> follow-up 28-35 days, median 33d<br> n=1157/1162<br> Parallel groups<br> double blind <br> Europe, Australia, South Africa </td> </tr> <tr> <td> <a href="index.html"> RE-MODEL (150mg), 2007 </a> <br> </td> <td> dabigatran etexilate 150 mg q.d. for 6-10 days<br>  <i>versus</i> <br> Enoxaparin 40 mg q.d. for 6-10 days </td> <td> Total knee replacement </td> <td> follow-up 6-10 days, mean 8 days<br> n=708/699<br> Parallel groups<br> double blind <br> Europe, Australia, South Africa </td> </tr> <tr> <td> <a href="index.html"> RE-NOVATE (150mg), 2007 </a> <br> NCT00168818 </td> <td> dabigatran etexilate 150 mg q.d. 28-35 days <br>  <i>versus</i> <br> Enoxaparin 40 mg q.d. for 28-25 days </td> <td> Total hip replacement </td> <td> follow-up 28-35 days, median 33d<br> n=1174/1162<br> <br> double blind <br> Europe, Australia, South Africa </td> </tr> <tr> <td> <a href="index.html"> RE-MOBILIZE (150mg), 2008 </a> <br> </td> <td> dabigatran etexilate 150 mg q.d. for 12-15 days <br>  <i>versus</i> <br> enoxaparin 30 mg SC BID after surgery for 12-15 days </td> <td> Total knee replacement </td> <td> follow-up 12-15 days, median 14d<br> n=877/876<br> <br> double blind <br> US, Canada, Mexico, UK </td> </tr> <tr> <td> <a href="index.html"> Hull, 1993 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Logiparin 75 anti-Xa IU /kg x1 </td> <td> THR or TKR (stratified) </td> <td> follow-up Day 14 or discharge<br> n=721/715<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> RD Heparin, 1994 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Ardeparin 50 anti-Xa IU /kg or 90 anti-Xa IU /kg x1 </td> <td> THR or TKR </td> <td> follow-up 3 months<br> n=403/770<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Hamulyak, 1994 </a> <br> </td> <td> Acenocoumarol<br>  <i>versus</i> <br> Nadroparin 60 anti-Xa IU /kg x1 </td> <td> THR or TKR (stratified) </td> <td> follow-up Day 10 � 2<br> n=342/330<br> <br> single blind <br> </td> </tr> <tr> <td> <a href="index.html"> Leclerc, 1996 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Enoxaparin 30 mg x2 </td> <td> TKR </td> <td> follow-up 6 months<br> n=334/336<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> Francis, 1997 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Dalteparin 5000 anti-Xa IU x1 </td> <td> THR </td> <td> follow-up Day 7 � 2<br> n=292/288<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Heit, 1997 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Ardeparin 25, 35, 50 anti-Xa U /kg x2 </td> <td> TKR </td> <td> follow-up Days 5�14<br> n=279/554<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> Colwell, 1999 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Enoxaparin 30 mg x2 </td> <td> THR </td> <td> follow-up 3 months<br> n=1495/1516<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Hull, 2000 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Dalteparin 5000 anti-Xa IU x1 </td> <td> THR </td> <td> follow-up Day 6 � 2<br> n=489/983<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> Fitzgerald, 2001 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Enoxaparin 30 mg x2 </td> <td> TKR </td> <td> follow-up 3 weeks<br> n=176/173<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Samama, 2001 </a> <br> </td> <td> Acenocoumarol<br>  <i>versus</i> <br> Reviparin 4200 anti-Xa IU x1 </td> <td> THR </td> <td> follow-up 6 weeks<br> n=645/644<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Borsgtrom, 1965 </a> <br> </td> <td> Dicoumarol<br>  <i>versus</i> <br> No treatment </td> <td> HFS </td> <td> follow-up 3�4 weeks<br> n=29/29<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Eskeland, 1966 </a> <br> </td> <td> Phenindione<br>  <i>versus</i> <br> No treatment </td> <td> HFS </td> <td> follow-up 3 months<br> n=100/100<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Myrhe, 1969 </a> <br> </td> <td> Wwarfarin<br>  <i>versus</i> <br> Placebo </td> <td> HFS </td> <td> follow-up 3 weeks<br> n=50/55<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> Hamilton, 1970 </a> <br> </td> <td> Phenindione<br>  <i>versus</i> <br> No treatment </td> <td> HFS </td> <td> follow-up 3�10 months<br> n=38/38<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Pinto, 1970 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> No treatment </td> <td> Hip surgery </td> <td> follow-up > 3 weeks<br> n=25/25<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Hume, 1973 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> No treatment </td> <td> THR </td> <td> follow-up Discharge<br> n=17/19<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Morris, 1976 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> No treatment </td> <td> HFS </td> <td> follow-up 3 months<br> n=80/80<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Powers, 1989 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> No treatment </td> <td> HFS </td> <td> follow-up 3 months<br> n=65/63<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Myrhe, 1969 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Dextran 70 </td> <td> HFS </td> <td> follow-up 3 weeks<br> n=50/55<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> Harris, 1972 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Dextran 40 </td> <td> THR </td> <td> follow-up NA<br> n=114/113<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Barber, 1977 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Dextran 70 </td> <td> THR </td> <td> follow-up 11�14 days<br> n=58/51<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Francis, 1983 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Dextran 40 </td> <td> THR or TKR (stratified) </td> <td> follow-up 5�7 days<br> n=57/43<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Hume, 1973 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Sudoxicam </td> <td> THR </td> <td> follow-up Discharge<br> n=52/51<br> <br> single blind <br> </td> </tr> <tr> <td> <a href="index.html"> Powers, 1989 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Aspirin 650 mg x2 </td> <td> HFS </td> <td> follow-up 3 months<br> n=65/66<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Lotke, 1997 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Aspirin 325 mg x2 </td> <td> THR or TKR (stratified) </td> <td> follow-up 6 months<br> n=146/166<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Paiement, 1987 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> IPC </td> <td> THR </td> <td> follow-up 12 days<br> n=80/83<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Bailey, 1991 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> IPC </td> <td> THR </td> <td> follow-up 5�7 days<br> n=45/50<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Kaempffe, 1991 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> IPC </td> <td> THR or TKR (stratified) </td> <td> follow-up At least 2 months<br> n=52/48<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Francis, 1992 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> IPC </td> <td> THR </td> <td> follow-up 6�8 days<br> n=103/98<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Hume, 1973 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> UFH 5000 x3 </td> <td> THR </td> <td> follow-up Discharge<br> n=17/18<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Barber, 1977 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> UFH 5000 x2 </td> <td> THR </td> <td> follow-up 11�14 days<br> n=58/19<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> Gerhart, 1991 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Danaparoid 750 U x2 </td> <td> HFS </td> <td> follow-up 9 days<br> n=131/132<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> van Comp, 1998 </a> <br> </td> <td> Warfarin<br>  <i>versus</i> <br> Danaparoid 750 U x2 </td> <td> THR </td> <td> follow-up 3 months<br> n=247/241<br> <br> Open <br> </td> </tr> <tr> <td> <a href="index.html"> van Geloven, 1977 </a> <br> </td> <td> Acenocoumarol<br>  <i>versus</i> <br> UFH 4000 �x2 </td> <td> THR </td> <td> follow-up NA<br> n=11/11<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> ODIXa-HIP 10mg, 2006 </a> <br> </td> <td> rivaroxaban 10mg daily for 5�9 days<br>  <i>versus</i> <br> once-daily subcutaneous enoxaparin dose of 40 mg for 5�9 days </td> <td> patients undergoing elective total hip replacement </td> <td> follow-up 5-9 days<br> n=142/157<br> Parallel groups<br> double blind <br> Europe, Israel </td> </tr> <tr> <td> <a href="index.html"> ODIXa-KNEE, 2005 </a> <br> </td> <td> BAY 59-7939 5mg b.i.d. for 5�9 days<br>  <i>versus</i> <br> enoxaparin 30 mg b.i.d. for 5�9 days </td> <td> patients undergoing elective total knee replacement </td> <td> follow-up 5-9 days<br> n=102/105<br> Parallel groups<br> double blind <br> North America </td> </tr> <tr> <td> <a href="index.html"> APROPOS 2.5mg, 2007 </a> <br> NCT00097357 </td> <td> apixaban 2.5mg BID for 12 days<br>  <i>versus</i> <br> enoxaparin 30mg twice daily for 12 days </td> <td> patients undergoing elective total knee replacement surgery </td> <td> follow-up 12 days<br> n=153/152<br> Parallel groups<br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> RECORD 1, 2008 </a> <br> NCT00329628 </td> <td> rivaroxaban 10mg once daily for 35 days<br>  <i>versus</i> <br> enoxaparin 40mg subcutaneous once daily for 31-39 days </td> <td> patients undergoing total hip arthroplasty </td> <td> follow-up 36 days (range 30-42)<br> n=2266/2275<br> Parallel groups<br> double blind <br> 27 countries worldwide </td> </tr> <tr> <td> <a href="index.html"> RECORD 2, 2008 </a> <br> NCT00332020 </td> <td> extended thromboprophylaxis with rivaroxaban 10mg once daily for 31-39 days<br>  <i>versus</i> <br> enoxaparin 40mg subcutaneous once daily for 10-14 days </td> <td> patients undergoing elective total hip replacement </td> <td> follow-up 30-42 days<br> n=1252/1257<br> Parallel groups<br> double blind <br> 21 countries worldwide </td> </tr> <tr> <td> <a href="index.html"> RECORD 3, 2008 </a> <br> NCT00361894 </td> <td> rivaroxaban 10 mg once daily for 10- 14 days<br>  <i>versus</i> <br> enoxaparin 40 mg subcutaneous once daily for 10-14 days </td> <td> patients undergoing total knee arthroplasty </td> <td> follow-up 13-17 days<br> n=1254/1277<br> Parallel groups<br> double blind <br> 19 countries worldwide </td> </tr> <tr> <td> <a href="index.html"> RECORD 4, 2009 </a> <br> NCT00362232 </td> <td> rivaroxaban 10mg once daily for 10 to 14 days<br>  <i>versus</i> <br> enoxaparin 30 mg twice daily by subcutaneous injection for 10-14 days </td> <td> patients who had undergone total-knee-replacement surgery </td> <td> follow-up 40 days<br> n=1584/1564<br> Parallel groups<br> double blind <br> 12 countries </td> </tr> <tr> <td> <a href="index.html"> ADVANCE-1, 2008 </a> <br> NCT00371683 </td> <td> apixaban 2.5 mg orally twice daily for 10 to 14 days<br>  <i>versus</i> <br> enoxaparin 30mg subcutaneously every 12 hours for 10-14 days </td> <td> patients undergoing knee-replacement surgery </td> <td> follow-up 10-14 days<br> n=1599/1596<br> Parallel groups<br> double blind <br> 14 countries </td> </tr> <tr> <td> <a href="TRC_t10332.html"> ADVANCE 3, 2010 </a> <br> NCT00423319 </td> <td> apixaban 2.5mg twice daily for 35 days<br>  <i>versus</i> <br> enoxaparin 40mg once daily for 35 days </td> <td> patients undergoing elective total hip replacement surgery </td> <td> follow-up 35 days (+60)<br> n=2708/2699<br> Parallel groups<br> double blind <br> 21 countries </td> </tr> <tr> <td> <a href="index.html"> ADVANCE 2, 2010 </a> <br> NCT00452530 </td> <td> apixaban 2.5mg twice daily during 12 days<br>  <i>versus</i> <br> enoxaparin 40mg once daily 12 days </td> <td> patients undergoing elective unilateral or bilateral total knee replacement </td> <td> follow-up 12 days<br> n=1528/1529<br> Parallel groups<br> double blind <br> 27 countries </td> </tr> <tr> <td> <a href="TRC_t11113.html"> RE-NOVATE 2, 0 </a> <br> NCT00657150 </td> <td> dabigatran 220mg once daily for 28-35 Days<br>  <i>versus</i> <br> enoxaparin 40mg subcutaneous once daily for 28-35 Days </td> <td> patients undergoing total hip-replacement surgery </td> <td> follow-up 28-35 days (mean 32d)<br> n=1010/1003<br> Parallel groups<br> double-blind <br> </td> </tr> <tr> <td> <a href="index.html"> STARS J-V, </a> <br> </td> <td> edoxaban 30 mg once daily for 11 to 14 days<br>  <i>versus</i> <br> subcutaneous enoxaparin 2,000 IU, equivalent to 20 mg, twice daily (BID) for 11 to 14 days </td> <td> total hip arthroplasty </td> <td> follow-up <br> n=255/248<br> Parallel groups<br> double-blind <br> japan </td> </tr> </table> <h2>References</h2> <p> <b>RE-MOBILIZE (220mg), 2008 : </b> The Oral Thrombin Inhibitor Dabigatran Etexilate vs the North American Enoxaparin Regimen for the Prevention of Venous Thromboembolism after Knee Arthroplasty Surgery. <i>J Arthroplasty 2008;:</i> [PMID 18534438] </p> <p> <b>RE-MODEL (220mg), 2007 : </b> Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, K�lebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, B�ller HROral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. <i>J Thromb Haemost 2007 Nov;5:2178-85</i> [PMID 17764540] </p> <p> <b>RE-NOVATE (220mg), 2007 : </b> Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, B�ller HRDabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. <i>Lancet 2007;370:949-56</i> [PMID 17869635] </p> <p> <b>RE-MODEL (150mg), 2007 : </b> Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, K�lebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, B�ller HROral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. <i>J Thromb Haemost 2007;5:2178-85</i> [PMID 17764540] 10.1111/j.1538-7836.2007.02748.x </p> <p> <b>RE-NOVATE (150mg), 2007 : </b> Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, B�ller HRDabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. <i>Lancet 2007;370:949-56</i> [PMID 17869635] </p> <p> <b>RE-MOBILIZE (150mg), 2008 : </b> Ginsberg JS, Davidson BL, Comp PC, Francis CW, Friedman RJ, Huo MH, Lieberman JR, Muntz JE, Raskob GE, Clements ML, Hantel S, Schnee JM, Caprini JAOral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. <i>J Arthroplasty 2009;24:1-9</i> [PMID 18534438] 10.1016/j.arth.2008.01.132 </p> <p> <b>BISTRO II (225mg bid), 2005 : </b> Eriksson BI, Dahl OE, B�ller HR, Hettiarachchi R, Rosencher N, Bravo ML, Ahnfelt L, Piovella F, Stangier J, K�lebo P, Reilly PA new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial. <i>J Thromb Haemost 2005 Jan;3:103-11</i> [PMID 15634273] </p> <p> <b>Hull, 1993 : </b> Hull R, Raskob G, Pineo G, Rosenbloom D, Evans W, Mallory T, Anquist K, Smith F, Hughes G, Green DA comparison of subcutaneous low-molecular-weight heparin with warfarin sodium for prophylaxis against deep-vein thrombosis after hip or knee implantation. <i>N Engl J Med 1993;329:1370-6</i> [PMID 8413432] </p> <p> <b>RD Heparin, 1994 : </b> RD heparin compared with warfarin for prevention of venous thromboembolic disease following total hip or knee arthroplasty. RD Heparin Arthroplasty Group. <i>J Bone Joint Surg Am 1994;76:1174-85</i> [PMID 8056798] </p> <p> <b>Hamulyak, 1994 : </b> Hamuly�k K, Lensing AW, van der Meer J, Smid WM, van Ooy A, Hoek JASubcutaneous low-molecular weight heparin or oral anticoagulants for the prevention of deep-vein thrombosis in elective hip and knee replacement? Fraxiparine Oral Anticoagulant Study Group. <i>Thromb Haemost 1995;74:1428-31</i> [PMID 8772214] </p> <p> <b>Leclerc, 1996 : </b> Leclerc JR, Geerts WH, Desjardins L, Laflamme GH, L'Esp�rance B, Demers C, Kassis J, Cruickshank M, Whitman L, Delorme FPrevention of venous thromboembolism after knee arthroplasty. A randomized, double-blind trial comparing enoxaparin with warfarin. <i>Ann Intern Med 1996;124:619-26</i> [PMID 8607589] </p> <p> <b>Francis, 1997 : </b> Francis CW, Pellegrini VD Jr, Totterman S, Boyd AD Jr, Marder VJ, Liebert KM, Stulberg BN, Ayers DC, Rosenberg A, Kessler C, Johanson NAPrevention of deep-vein thrombosis after total hip arthroplasty. Comparison of warfarin and dalteparin. <i>J Bone Joint Surg Am 1997;79:1365-72</i> [PMID 9314399] </p> <p> <b>Heit, 1997 : </b> Heit JA, Berkowitz SD, Bona R, Cabanas V, Corson JD, Elliott CG, Lyons REfficacy and safety of low molecular weight heparin (ardeparin sodium) compared to warfarin for the prevention of venous thromboembolism after total knee replacement surgery: a double-blind, dose-ranging study. 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The North American Fragmin Trial Investigators. <i>Arch Intern Med 2000;160:2199-207</i> [PMID 10904464] </p> <p> <b>Fitzgerald, 2001 : </b> Fitzgerald RH Jr, Spiro TE, Trowbridge AA, Gardiner GA Jr, Whitsett TL, O'Connell MB, Ohar JA, Young TRPrevention of venous thromboembolic disease following primary total knee arthroplasty. 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