Food and Drug Administration
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
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In addition, for this particular document, a technical problem with the software has resulted in a misnumbering of the pages. In Tab 7 of the FDA briefing document, page 66 is followed immediately by page 74. This is strictly a problem with the page numbering, and no text has been deleted from the document.