Article 5 drug efficacy drug safety 5 human 5 Humans 4 female 4 male 4 Female 3 major clinical study 3 Adverse Drug Reaction Reporting Systems 2 Aged 2 Food and Drug Administration 2 Male 2 Middle Aged 2 United States 2 United States Food and Drug Administration 2 adult 2 adverse drug reaction 2 adverse outcome 2 aged 2 constipation 2 controlled study 2 drug hypersensitivity 2 drug surveillance program 2 middle aged 2 outcome assessment 2 Adolescent 1 American 1 Anti-HIV Agents 1 Bariatric surgery 1