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. 2019 Mar 27;10:277. doi: 10.3389/fneur.2019.00277

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Copyright © 2019 Metcalf, Huntsman, Garcia, Kochanski, Chikinda, Watanabe, Underwood, Vanegas, Smith, White and Bulaj.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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Developing music-based and behavioral interventions and their combinations with pharmaceutical drugs using digital therapeutics strategy. Streaming of patient-preferred music can be combined with disease self-management and behavioral therapy yielding a mobile app for non-pharmacological interventions. Step 1: Once the mobile app is clinically tested for efficacy in pivotal randomized controlled trial (RCT) and receives the regulatory approval or clearance, it becomes a mobile medical app (software as a medical device). Step 2: testing clinical efficacy of combining a pharmaceutical drug (ibuprofen structure is shown as an example of an analgesic drug) with the mobile medical app can lead to premarket application for the regulatory approval of drug-device combination product in which the mobile medical app is a medical device.