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Houda Haj-Ibrahim, Marina Komaroff, Suzanne Meeves, Mahwish Khan, and Mariacristina Castelli are employees of and received non-financial support from Noven Pharmaceuticals.","order":1,"name":"Ethics","label":"Conflicts of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study protocols were reviewed and approved by independent ethics committees or institutional review boards (IRBs) at each study site (Supplemental Table\u00a0\n                      \n                      ).\u00a0Additional study details such as the protocol and ethical approval details are available at\n                      \n                      and\n                      \n                      . 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