Document ID: FDA-2008-Q-0323-0006
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-06T04:00Z

<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">
<HTML>
<HEAD>
<META name="generator" content="PDFCreactiveX HTML Export">
<META name="creation-date" content="05/06/2008 08:21:18 ">
<TITLE></TITLE>
<SCRIPT LANGUAGE="JavaScript1.2"> var agt=navigator.userAgent.toLowerCase();if ( (parseInt(navigator.appVersion)>=4) &&(agt.indexOf('mozilla')!=-1) && (agt.indexOf('spoofer')==-1)&& (agt.indexOf('compatible') == -1) ){msie = false;} else if ( (parseInt(navigator.appVersion)>=4) &&(agt.indexOf('msie') != -1) ) {msie = true;	} page=0;</SCRIPT>
</HEAD>
<BODY bgcolor="#ffffff" text="#000000" topmargin=0 leftmargin=0 marginheight=0 marginwidth=0 >
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:0.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p0.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:792.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p1.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:1584.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:1584.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p2.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:2376.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:2376.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p3.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3168.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:3168.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p4.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:3960.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:3960.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p5.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:4752.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:4752.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p6.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:5544.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:5544.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p7.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:6336.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:6336.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p8.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:7128.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:7128.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p9.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:7920.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:7920.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p10.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:8712.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:8712.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p11.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:9504.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:9504.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p12.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:10296.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:10296.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p13.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:11088.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:11088.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p14.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:11880.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:11880.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p15.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:12672.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:12672.00pt;z-index:2;"><IMG WIDTH=3300 HEIGHT=2528 style="width:792pt;height:606pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p16.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:13278.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:13278.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p17.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:14070.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:14070.00pt;z-index:2;"><IMG WIDTH=3300 HEIGHT=2528 style="width:792pt;height:606pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p18.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:14676.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:14676.00pt;z-index:2;"><IMG WIDTH=3300 HEIGHT=2528 style="width:792pt;height:606pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p19.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:15282.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:15282.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p20.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:16074.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:16074.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p21.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:16866.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:16866.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p22.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:17658.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:17658.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p23.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:18450.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:18450.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p24.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:19242.00pt"> </SPAN>
<SPAN STYLE="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:19242.00pt;z-index:2;"><IMG WIDTH=2528 HEIGHT=3300 style="width:606pt;height:792pt;" SRC="outputfile-2028494567.htm_files\outputfile-2028494567_p25.png"></SPAN>
<SPAN STYLE="position:absolute;left:71.76pt;top:20034.00pt"> </SPAN>
</BODY>
</HTML>