Validation of the post sleep questionnaire for assessing subjects with restless legs syndrome: results from two double-blind,multicenter, placebo-controlled clinical trials |
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| Authors: | Daniel M Canafax Abhijeet Bhanegaonkar Murtuza Bharmal Michael Calloway |
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| Institution: | (1) XenoPort, Inc., Santa Clara, CA, USA;(2) West Virginia University School of Pharmacy, Morgantown, WV, USA;(3) GlaxoSmithKline R&D China, Shanghai, China;(4) Quintiles, Rockville, MD, USA;(5) GlaxoSmithKline, Research Triangle Park, NC, USA |
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| Abstract: | Background Because of the subjective nature of Restless Legs Syndrome (RLS) symptoms and the impact of these symptoms on sleep, patient-reported
outcomes (PROs) play a prominent role as study endpoints in clinical trials investigating RLS treatments. The objective of
this study was to validate a new measure, the Post Sleep Questionnaire (PSQ), to assess sleep dysfunction in subjects with
moderate-to-severe RLS symptoms. |
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