affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, affiliation not provided to SSRN, Government of the United States of America - Food and Drug Administration (FDA), Government of the United States of America - Food and Drug Administration (FDA), affiliation not provided to SSRN and University of Texas at Austin

Government of the United States of America - Food and Drug Administration (FDA), Government of the United States of America - Food and Drug Administration (FDA), Government of the United States of America - Food and Drug Administration (FDA), Government of the United States of America - Food and Drug Administration (FDA), Government of the United States of America - Food and Drug Administration (FDA), Government of the United States of America - Food and Drug Administration (FDA) and Government of the United States of America - Food and Drug Administration (FDA)