Safety and tolerability of a novel oral nutritional supplement in healthy volunteers |
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| Authors: | Annalisa Bonelli Pierantonio Menna Giorgio Minotti Silvia Angeletti Alessandro Comandini Rossella Picollo Elisa Quarchioni Vincenzo Russo Enrica Salvatori Francesca Ferravante Sara Emerenziani Michele Cicala Maurizio Muscaritoli |
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| Affiliation: | 1. Angelini RR&D (Research, Regulatory & Development) – Angelini S.p.A., S.Palomba-Pomezia, Rome, Italy;2. Clinical Pharmacology Unit, University Campus Bio-Medico Rome, Italy;3. Unit of Clinical Laboratory Science, University Campus Bio-Medico, Rome, Italy;4. Gastroenterology Unit, University Campus Bio-Medico, Rome, Italy;5. Department of Translational and Precision Medicine, Sapienza University of Rome, Italy |
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| Keywords: | Foods for special medical purposes Glycogen Palatability High-density energy Osmolarity Safety AEs" },{" #name" :" keyword" ," $" :{" id" :" kwrd0045" }," $$" :[{" #name" :" text" ," _" :" Adverse Events BMI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0055" }," $$" :[{" #name" :" text" ," _" :" Body Mass Index EP" },{" #name" :" keyword" ," $" :{" id" :" kwrd0065" }," $$" :[{" #name" :" text" ," _" :" Evaluable Population FSMPs" },{" #name" :" keyword" ," $" :{" id" :" kwrd0075" }," $$" :[{" #name" :" text" ," _" :" Foods for Special Medical Purposes GI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0085" }," $$" :[{" #name" :" text" ," _" :" Gastrointestinal IP" },{" #name" :" keyword" ," $" :{" id" :" kwrd0095" }," $$" :[{" #name" :" text" ," _" :" Investigational Product MDs" },{" #name" :" keyword" ," $" :{" id" :" kwrd0105" }," $$" :[{" #name" :" text" ," _" :" maltodextrins MedDRA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0115" }," $$" :[{" #name" :" text" ," _" :" Medical Dictionary for Regulatory Activities OGTT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0125" }," $$" :[{" #name" :" text" ," _" :" Oral glucose tolerance test PTAEs" },{" #name" :" keyword" ," $" :{" id" :" kwrd0135" }," $$" :[{" #name" :" text" ," _" :" pre-treatment adverse events TEAEs" },{" #name" :" keyword" ," $" :{" id" :" kwrd0145" }," $$" :[{" #name" :" text" ," _" :" Treatment Emergent Adverse Events TP" },{" #name" :" keyword" ," $" :{" id" :" kwrd0155" }," $$" :[{" #name" :" text" ," _" :" Treated Population |
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