Uncontrolled data on a marketed vaccine for bacterial meningitis, MeningAway, indicate that the incidence of ear infections is lower for the population of people who were vaccinated with MeningAway. P

Uncontrolled data on a marketed vaccine for bacterial meningitis, MeningAway, indicate that the incidence of ear infections is lower for the population of people who were vaccinated with MeningAway. Patients who received a competitor’s meningitis vaccine, NoMening, saw no such drop in the incidence of ear infections. Assuming the goal is to minimize the cost of approval for this new indication, which of the following items would be part of an application to claim that MeningAway is effective against ear infections.

Select one or more: