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Harvard Med Sch, Brigham & Womens Hosp, Div Pharmacoepidemiol & Pharmacoecon, Dept Med,Program Regulat Therapeut & Law PORTAL, Boston, MA 02115 USA Harvard Med Sch, Brigham & Womens Hosp, Div Pharmacoepidemiol & Pharmacoecon, Dept Med,Program Regulat Therapeut & Law PORTAL, Boston, MA 02115 USA