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If the established threshold was reached within 2 seconds, the red circle was replaced by a green circle

doi: 10.1192/bjp.135.3.249 120 PepersackTGarbusinskiJRobberechtJBeyerIWillemsDFussM

10.1016/j.pep.2010.01.016

10.1021/bi002513o 11 CohenS

By definition, it must be classified as an implant and automatically placed in Class III, requiring scientific proof of safety [43 FR 32988, July 28, 1978] The FDA defines implant as a device that is placed into a surgically or naturally formed cavity of the human body