Table I: Evolution of the subgroup RMITT-2 (number of participants, efficacy) / Table II: Evolution and changes in the definition of subgroup RMITT-2

Data submitted by Merck to the Food and Drug Administration (FDA) for Gardasil® approval (published and unpublished data). These tables show that the definition of the subgroup “negative to 14 HPV types” population (RMITT-2) changed several times between 2006 and 2010.