FP fractional polynomial ROCI Response Over Continuous Intervention 1 Background The Response Over Continuous Intervention (ROCI) design, introduced by Quartagno et al. (originally under the DURATIONS title [1, 2]), provides an alternative to conventional two-arm non-inferiority trials for studies aimed at late-phase optimization of a continuous aspect of treatment intervention. This approach has potential applications in refining treatment dosing, frequency, and duration.