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In one embodiment, efficacy of the pharmaceutical formulations described herein may be evaluated using a Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF), a self-reported questionnaire, with 16 items, that evaluate overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications

Class I devices dont need TGA assessment or certification

M.LiuY.QianZ

Shapiro DD, Soeung M, Perelli L, Dondossola E, Surasi DS, Tripathi DN, Bertocchio JP, Carbone F, Starbuck MW, Van Alstine ML, Rao P, Katz MHG, Parker NH, Shah AY, Carugo A, Heffernan TP, Schadler KL, Logothetis C, Walker CL, Wood CG, Karam JA, Draetta GF, Tannir NM , Genovese G, Msaouel P