Placebo response mitigation training
To mitigate placebo response, patients viewed a training video at screening entitled: “What It Means to Participate in Clinical Research Studies”, which explained the role of research subjects in a clinical trial, what to expect from clinical site staff, and the importance of randomization and placebo in a controlled trial. Prior to site activation, investigators, study coordinators, and audiologists underwent training on placebo response which included a discussion of factors affecting placebo response and best practices of how to interact with trial patients (e.g., neutral interactions with modest rapport, avoiding discussion of expected positive or negative outcomes) to minimize the risk of high placebo response.