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Academic Pediatrics
Volume 9, Issue 2
, Pages 81-88
, March 2009
Off-Label Prescribing to Children in the United States Outpatient Setting
References
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PII: S1876-2859(08)00269-6
doi: 10.1016/j.acap.2008.11.010
© 2009 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.
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Academic Pediatrics
Volume 9, Issue 2
, Pages 81-88
, March 2009
