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| Dockets Entered On April 14, 2006
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| Docket #
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| Title
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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| 2006D-0044
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| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
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| 1997S-0162
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| 30-Day Structure Function Claim Notification Letters Dietary
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| LET 17534
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17535
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17536
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17537
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17538
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17539
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17540
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17541
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17542
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17543
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| Perrigo Company of South Carolina
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| Vol #:
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| 161
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| LET 17544
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| Tabak's Health Products
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| Vol #:
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| 161
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| LET 17545
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| Miracle Breakthrough Lab, Inc.
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| Vol #:
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| 161
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| LET 17546
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| Avon Products, Inc.
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| Vol #:
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| 161
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| LET 17547
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| Avon Products, Inc.
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| Vol #:
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| 161
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| LET 17548
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| Avon Products, Inc.
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| Vol #:
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| 161
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| LET 17549
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| Avon Products, Inc.
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| Vol #:
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| 161
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| LET 17550
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| Avon Products, Inc.
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| Vol #:
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| 161
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| LET 17551
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| Gaia Herbs
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| Vol #:
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| 161
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| LET 17552
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| Gulf Biomedical Corporation
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| Vol #:
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| 161
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| LET 17553
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| Nioxin Reserach Laboratories, Inc.
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| Vol #:
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| 161
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|
|
| 2005P-0411
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| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
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|
|
| C 6081
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| J. Adams
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| Vol #:
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| 89
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|
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| C 6082
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| D. Boltres
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| Vol #:
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| 89
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|
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| C 6083
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| A. Whitlington
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| Vol #:
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| 89
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|
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| C 6084
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| M. Hodgin
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| Vol #:
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| 89
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|
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| C 6085
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| S. Burch
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| Vol #:
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| 89
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|
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| C 6086
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| J. Cunninham
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| Vol #:
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| 89
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|
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| C 6087
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| V. Prouin
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| Vol #:
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| 89
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| C 6088
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| J. Syrja
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| Vol #:
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| 89
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|
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| C 6089
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| L. Cain
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| Vol #:
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| 89
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|
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| C 6090
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| T. Spidel
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| Vol #:
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| 89
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| | | | | | | |
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| C 6091
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| R. Mishler
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| Vol #:
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| 89
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|
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| C 6092
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| R. Mishler
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| Vol #:
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| 89
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|
|
| C 6093
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| K. Keefer
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| Vol #:
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| 89
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|
|
| C 6094
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| S. Bently
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| Vol #:
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| 89
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|
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| C 6095
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| M. Cope
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| Vol #:
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| 89
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| C 6096
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| R. Price
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| Vol #:
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| 89
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|
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| C 6097
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| K. Voss
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| Vol #:
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| 89
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|
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| C 6098
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| L. Lee
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| Vol #:
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| 89
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|
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| C 6099
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| L. Adams
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| Vol #:
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| 89
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|
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| C 6100
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| J. Smith
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| Vol #:
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| 89
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|
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| C 6101
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| R. Selkowitz
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| Vol #:
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| 89
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|
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| C 6102
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| J. Lia
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| Vol #:
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| 89
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|
|
| C 6103
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| M. Ochoa
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| Vol #:
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| 89
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|
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| C 6104
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| B. Freeze
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| Vol #:
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| 89
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|
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| C 6105
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| C. Breazeak
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| Vol #:
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| 89
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|
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| C 6106
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| L. Speaks
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| Vol #:
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| 89
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|
|
| C 6107
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| R. Sauers
|
| Vol #:
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| 89
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|
|
| C 6108
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| C. Breazeak
|
| Vol #:
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| 89
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|
|
| C 6109
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| A. Clark
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| Vol #:
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| 89
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|
|
| C 6110
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| J. Somers
|
| Vol #:
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| 89
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|
|
| C 6111
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| E. Madigan
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| Vol #:
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| 89
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|
|
| C 6112
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| L. Jenkins
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| Vol #:
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| 89
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|
|
| C 6113
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| G. Rhodes
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| Vol #:
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| 89
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|
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| C 6114
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| G. Rhodes
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| Vol #:
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| 89
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|
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| C 6115
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| M. Bennett
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| Vol #:
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| 89
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|
|
| C 6116
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| D. Dowling
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| Vol #:
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| 89
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|
|
| C 6117
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| D. Davis
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| Vol #:
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| 89
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|
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| C 6118
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| V. Andrews
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| Vol #:
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| 89
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|
|
| C 6119
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| J. Bishol
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| Vol #:
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| 89
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|
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| C 6120
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| D. Gram
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| Vol #:
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| 89
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|
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| C 6121
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| P. Mattas
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| Vol #:
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| 89
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|
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| C 6122
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| P. Mann
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| Vol #:
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| 89
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|
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| C 6123
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| R. Saylor
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| Vol #:
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| 89
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|
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| C 6124
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| M. Haggard
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| Vol #:
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| 89
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|
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| C 6125
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| D. Wright
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| Vol #:
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| 89
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|
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| C 6126
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| W. Phillips
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| Vol #:
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| 89
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| C 6127
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| C. Phillips
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| Vol #:
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| 89
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|
| | | | | | | |
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| C 6128
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| K. Alderson
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| Vol #:
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| 89
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|
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| C 6129
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| M. Parke
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| Vol #:
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| 89
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|
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| C 6130
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| P. Joensuu
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| Vol #:
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| 89
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|
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| C 6131
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| N. Callahan
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| Vol #:
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| 89
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|
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| C 6132
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| C. Brown
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| Vol #:
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| 89
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|
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| C 6133
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| J. Watson
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| Vol #:
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| 89
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|
|
| C 6134
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| R. Onley
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| Vol #:
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| 89
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|
|
| C 6135
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| S. Brien
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| Vol #:
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| 89
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|
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| C 6136
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| D. Harmony
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| Vol #:
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| 89
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|
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| C 6137
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| A. Miller
|
| Vol #:
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| 89
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|
|
| C 6138
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| S. Brien
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| Vol #:
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| 89
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|
|
| C 6139
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| K. Dunn
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| Vol #:
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| 89
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|
|
| C 6140
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| D. Garde
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| Vol #:
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| 89
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|
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| C 6141
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| Z. Hanno
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| Vol #:
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| 89
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|
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| C 6142
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| C. Dean
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| Vol #:
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| 89
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|
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| C 6143
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| M. Bilbo
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| Vol #:
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| 89
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|
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| C 6144
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| D. Mayer
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| Vol #:
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| 89
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|
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| C 6145
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| D. Ferguson
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| Vol #:
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| 89
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|
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| C 6146
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| S. Carter
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| Vol #:
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| 89
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|
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| C 6147
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| Dr. L. Collins
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| Vol #:
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| 89
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|
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| C 6148
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| E. Gardner, MD
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| Vol #:
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| 89
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|
|
| C 6149
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| B. Benz
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| Vol #:
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| 89
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|
|
| C 6150
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| A. Broomall
|
| Vol #:
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| 89
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|
|
| C 6151
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| K. Mujkic
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| Vol #:
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| 89
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|
|
| C 6152
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| K. Hamilton
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| Vol #:
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| 89
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|
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| C 6153
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| J. Bennett
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| Vol #:
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| 89
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|
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| C 6154
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| D. Sellars, N.D.
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| Vol #:
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| 89
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|
|
| C 6155
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| J. Zirbel
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| Vol #:
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| 89
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|
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| C 6156
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| M. Hondt
|
| Vol #:
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| 89
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|
|
| C 6157
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| P. Long
|
| Vol #:
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| 89
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|
|
| C 6158
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| R. Tafoya
|
| Vol #:
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| 89
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|
|
| C 6159
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| W. Allen
|
| Vol #:
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| 89
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|
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| C 6160
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| J. Martin
|
| Vol #:
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| 89
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|
|
| C 6161
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| S. Creswell
|
| Vol #:
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| 89
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|
|
| C 6162
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| M. Estes
|
| Vol #:
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| 89
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|
|
| C 6163
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| M. Green
|
| Vol #:
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| 89
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|
|
| C 6164
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| R. Ruby
|
| Vol #:
|
| 89
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|
| | | | | | | |
|
|
| C 6165
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| S. Struble
|
| Vol #:
|
| 89
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|
|
| C 6166
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| L. Lieberman
|
| Vol #:
|
| 89
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|
|
| C 6167
|
| P. Designs
|
| Vol #:
|
| 89
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|
|
| C 6168
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| Y. Schmitz
|
| Vol #:
|
| 89
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|
|
| C 6169
|
| I. Bryant
|
| Vol #:
|
| 89
|
|
|
| C 6170
|
| W. Moore
|
| Vol #:
|
| 89
|
|
|
| C 6171
|
| S. Meyer
|
| Vol #:
|
| 89
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|
|
| C 6172
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| C. Omlin
|
| Vol #:
|
| 89
|
|
|
| C 6173
|
| R. Creel
|
| Vol #:
|
| 89
|
|
|
| C 6174
|
| Eligible
|
| Vol #:
|
| 89
|
|
|
| C 6175
|
| J. Bowen
|
| Vol #:
|
| 89
|
|
|
| C 6176
|
| J. Nabet
|
| Vol #:
|
| 89
|
|
|
| C 6177
|
| C. Seymour
|
| Vol #:
|
| 89
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|
|
| C 6178
|
| N. Williams
|
| Vol #:
|
| 89
|
|
|
| C 6179
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| B. Lacina
|
| Vol #:
|
| 89
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|
|
| C 6180
|
| R. Goodman
|
| Vol #:
|
| 89
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|
|
| C 6181
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| A. Goodman
|
| Vol #:
|
| 89
|
|
|
| C 6182
|
| B. Godwin
|
| Vol #:
|
| 89
|
|
|
| C 6183
|
| T. Weinberg
|
| Vol #:
|
| 89
|
|
|
| C 6184
|
| R. Horn
|
| Vol #:
|
| 89
|
|
|
| C 6185
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| J. Twibell
|
| Vol #:
|
| 89
|
|
|
| C 6186
|
| C. Church
|
| Vol #:
|
| 89
|
|
|
| C 6187
|
| W. Boyer
|
| Vol #:
|
| 89
|
|
|
| C 6188
|
| J. Burel
|
| Vol #:
|
| 89
|
|
|
| C 6189
|
| L. Broesch
|
| Vol #:
|
| 89
|
|
|
| C 6190
|
| K. Cochran
|
| Vol #:
|
| 89
|
|
|
| C 6191
|
| K. Cochran
|
| Vol #:
|
| 89
|
|
|
| C 6192
|
| S. Taylor
|
| Vol #:
|
| 89
|
|
|
| C 6193
|
| M. Schiller
|
| Vol #:
|
| 89
|
|
|
| C 6194
|
| J. Wright
|
| Vol #:
|
| 89
|
|
|
| C 6195
|
| K. Kleber
|
| Vol #:
|
| 89
|
|
|
| C 6196
|
| A. Worth
|
| Vol #:
|
| 89
|
|
|
| C 6197
|
| D. Snowden
|
| Vol #:
|
| 89
|
|
|
| C 6198
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| G. Hughes
|
| Vol #:
|
| 89
|
|
|
| C 6199
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| P. Hughes
|
| Vol #:
|
| 89
|
|
|
| C 6200
|
| T. O'Neill
|
| Vol #:
|
| 89
|
|
|
| C 6201
|
| K. Lawrence
|
| Vol #:
|
| 89
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|
| | | | | | | |
|
|
| C 6202
|
| J. Kastner
|
| Vol #:
|
| 89
|
|
|
| C 6203
|
| J. Shannon
|
| Vol #:
|
| 89
|
|
|
| C 6204
|
| E. MAttiford
|
| Vol #:
|
| 89
|
|
|
| C 6205
|
| P. Fox
|
| Vol #:
|
| 89
|
|
|
| C 6206
|
| C. Fitzpatrick
|
| Vol #:
|
| 89
|
|
|
| C 6207
|
| R. Palmer
|
| Vol #:
|
| 89
|
|
|
| C 6208
|
| E. Starkweather
|
| Vol #:
|
| 89
|
|
|
| C 6209
|
| J. Trahan
|
| Vol #:
|
| 89
|
|
|
| C 6210
|
| P. Hall
|
| Vol #:
|
| 89
|
|
|
| C 6211
|
| D. Soller
|
| Vol #:
|
| 89
|
|
|
| C 6212
|
| S. Sample
|
| Vol #:
|
| 89
|
|
|
| C 6213
|
| P. Beck
|
| Vol #:
|
| 89
|
|
|
| C 6214
|
| L. Hartman
|
| Vol #:
|
| 89
|
|
|
| C 6215
|
| Eligible
|
| Vol #:
|
| 89
|
|
|
| C 6216
|
| D. Nackers
|
| Vol #:
|
| 89
|
|
|
| C 6217
|
| G. Morino
|
| Vol #:
|
| 89
|
|
|
| C 6218
|
| L. Waletzky, MD
|
| Vol #:
|
| 89
|
|
|
| C 6219
|
| S. McMahon
|
| Vol #:
|
| 89
|
|
|
| C 6220
|
| S. Viane
|
| Vol #:
|
| 89
|
|
|
| C 6221
|
| C. Clemens
|
| Vol #:
|
| 89
|
|
|
| C 6222
|
| F. Marquis
|
| Vol #:
|
| 89
|
|
|
| C 6223
|
| A. Ready
|
| Vol #:
|
| 89
|
|
|
| C 6224
|
| C. Potter
|
| Vol #:
|
| 89
|
|
|
| C 6225
|
| E. Verdouw
|
| Vol #:
|
| 89
|
|
|
| C 6226
|
| W. Dieck
|
| Vol #:
|
| 89
|
|
|
| C 6227
|
| J. Clark
|
| Vol #:
|
| 89
|
|
|
| C 6228
|
| D. Bradley
|
| Vol #:
|
| 89
|
|
|
| C 6229
|
| N. Allen
|
| Vol #:
|
| 89
|
|
|
| C 6230
|
| T. Goldstein
|
| Vol #:
|
| 89
|
|
|
| C 6231
|
| K. Brim
|
| Vol #:
|
| 89
|
|
|
| C 6232
|
| M. Bobier
|
| Vol #:
|
| 89
|
|
|
| C 6233
|
| S. Smith
|
| Vol #:
|
| 89
|
|
|
| C 6234
|
| M and C Irlenborn
|
| Vol #:
|
| 89
|
|
|
| C 6235
|
| B. Pippo
|
| Vol #:
|
| 89
|
|
|
| C 6236
|
| S. Dehor
|
| Vol #:
|
| 89
|
|
|
| C 6237
|
| E. Krokosz
|
| Vol #:
|
| 89
|
|
|
| C 6238
|
| K. McKee
|
| Vol #:
|
| 89
|
|
| | | | | | | | |
|
|
| C 6239
|
| E. Glass
|
| Vol #:
|
| 89
|
|
|
| C 6240
|
| K. Wendling
|
| Vol #:
|
| 89
|
|
|
| C 6241
|
| A. Earle
|
| Vol #:
|
| 89
|
|
|
| C 6242
|
| J. Allen
|
| Vol #:
|
| 89
|
|
|
| C 6243
|
| J. Stwart, PhD, MD
|
| Vol #:
|
| 89
|
|
|
| C 6244
|
| L. Duarte
|
| Vol #:
|
| 89
|
|
|
| C 6245
|
| S. Segarle
|
| Vol #:
|
| 89
|
|
|
| C 6246
|
| S. Knox
|
| Vol #:
|
| 89
|
|
|
| C 6247
|
| A. Thomas
|
| Vol #:
|
| 89
|
|
|
| C 6248
|
| M. Rudy
|
| Vol #:
|
| 89
|
|
|
| C 6249
|
| N. Moor
|
| Vol #:
|
| 89
|
|
|
| C 6250
|
| D. King
|
| Vol #:
|
| 89
|
|
|
| C 6251
|
| G. Bedsaul
|
| Vol #:
|
| 89
|
|
|
| C 6252
|
| M. Conlin
|
| Vol #:
|
| 89
|
|
|
| C 6253
|
| C. Conlin
|
| Vol #:
|
| 89
|
|
|
| C 6254
|
| B. Wagar
|
| Vol #:
|
| 89
|
|
|
| C 6255
|
| J. Darden
|
| Vol #:
|
| 89
|
|
|
| C 6256
|
| S. Boren
|
| Vol #:
|
| 89
|
|
|
| C 6257
|
| B. McElyunn
|
| Vol #:
|
| 89
|
|
|
| C 6258
|
| D. Caso
|
| Vol #:
|
| 89
|
|
|
| C 6259
|
| K. Franklin
|
| Vol #:
|
| 89
|
|
|
| C 6260
|
| G. Richardson
|
| Vol #:
|
| 89
|
|
|
| C 6261
|
| J. Aboott
|
| Vol #:
|
| 89
|
|
|
| C 6262
|
| P. Lathan
|
| Vol #:
|
| 89
|
|
|
| C 6263
|
| B. Gordon
|
| Vol #:
|
| 89
|
|
|
| C 6264
|
| B. Gordon
|
| Vol #:
|
| 89
|
|
|
| C 6265
|
| C. Scuro, D.M.D
|
| Vol #:
|
| 89
|
|
|
| C 6266
|
| R. Conn
|
| Vol #:
|
| 89
|
|
|
| C 6267
|
| K. Franklin
|
| Vol #:
|
| 89
|
|
|
| C 6268
|
| D. Plaisted, RN
|
| Vol #:
|
| 89
|
|
|
| C 6269
|
| E. Pittman
|
| Vol #:
|
| 89
|
|
|
| C 6270
|
| L. Inamorato
|
| Vol #:
|
| 89
|
|
|
| C 6271
|
| C. Strong
|
| Vol #:
|
| 89
|
|
|
| 2006D-0044
|
| Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
|
|
|
| C 9
|
| EORTC, European Organisation for Research and Treatment of Cancer
|
| Vol #:
|
| 2
|
|
|
| C 10
|
| International Society for Quality-of-Life Studies
|
| Vol #:
|
| 2
|
|
| | | | | | | |
|
|
| C 11
|
| Wyeth Pharmaceuticals Inc
|
| Vol #:
|
| 2
|
|
|
| C 12
|
| Roche Pharmaceuticals, Hoffmann-La Roche Inc
|
| Vol #:
|
| 2
|
|
|
| C 13
|
| Bristol-Myers Squibb
|
| Vol #:
|
| 2
|
|
|
| EC 9
|
| FACIT.org
|
| Vol #:
|
| 2
|
|
|
| EC 10
|
| Evanston Northwestern Healthcare and Northwestern
|
| Vol #:
|
| 2
|
|
|
| EC 11
|
| ERIQA Group
|
| Vol #:
|
| 2
|
|
|
| EC 12
|
| Pharm Res
|
| Vol #:
|
| 2
|
|
|
| EC 13
|
| London School of Hygiene
|
| Vol #:
|
| 2
|
|
|
| EC 14
|
| Alcon Research, LTD
|
| Vol #:
|
| 2
|
|
|
| EC 15
|
| Galen Research
|
| Vol #:
|
| 2
|
|
|
| EC 16
|
| Alcon Research, LTD
|
| Vol #:
|
| 2
|
|
|
| EC 17
|
| International Society for Quality of Life Research
|
| Vol #:
|
| 2
|
|
|
| EC 18
|
| Royal Holloway, University of London
|
| Vol #:
|
| 2
|
|
|
| EC 19
|
| QualityMetric Inc.
|
| Vol #:
|
| 2
|
|
|
| EC 20
|
| Johnson
|
| Vol #:
|
| 2
|
|
|
| EC 21
|
| Pfizer
|
| Vol #:
|
| 2
|
|
|
| EC 22
|
| CRF Inc.
|
| Vol #:
|
| 2
|
|
|
| EC 23
|
| QualityMetric Inc
|
| Vol #:
|
| 2
|
|
|
| EC 24
|
| Johnson and Johnson
|
| Vol #:
|
| 2
|
|
|
| EC 25
|
| ASCO
|
| Vol #:
|
| 2
|
|
|
| EC 26
|
| Center for Health Outcomes Research, UBC
|
| Vol #:
|
| 2
|
|
|
| EC 27
|
| ISPOR
|
| Vol #:
|
| 2
|
|
|
| EC 28
|
| Mapi Values
|
| Vol #:
|
| 2
|
|
|
| EC 29
|
| Boston Scientific Corporation
|
| Vol #:
|
| 2
|
|
|
| EC 30
|
| ClinPhone
|
| Vol #:
|
| 2
|
|
|
| EC 31
|
| invivodata, inc
|
| Vol #:
|
| 2
|
|
|
| EC 32
|
| PRO Consulting
|
| Vol #:
|
| 2
|
|
|
| EMC 1
|
| Abbott Laboratories
|
| Vol #:
|
| 1
|
|
|
| EMC 2
|
| Amgen
|
| Vol #:
|
| 1
|
|
|
| EMC 3
|
| Merck & Col, Inc.
|
| Vol #:
|
| 1
|
|
|