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. Author manuscript; available in PMC: 2024 Oct 28.
Published in final edited form as: Osteoarthritis Cartilage. 2018 Nov 19;27(4):571–579. doi: 10.1016/j.joca.2018.11.002

Fig. 1. Scenario 1 – prospective trial continuation.

Fig. 1.

PMA study design scenario 1 represents the continuation, post-approval, of the Phase 3 double blind, placebo controlled trial. The PMA study population contains the same patients as the original trial. Clinically relevant endpoints might be the time-to-event of joint replacement surgeries or clinically relevant symptomatic worsening or whichever is first.