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Safety and tolerability of a novel oral nutritional supplement in healthy volunteers
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
Institution: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
Abstract:
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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