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The Journal of Pediatrics
Volume 152, Issue 4
, Pages 527-533.e1
, April 2008
The Placebo Response in Studies of Acute Migraine
References
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No reprints are available from the authors.
PII: S0022-3476(07)00883-9
doi: 10.1016/j.jpeds.2007.09.024
© 2008 Mosby, Inc. All rights reserved.
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The Journal of Pediatrics
Volume 152, Issue 4
, Pages 527-533.e1
, April 2008
