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Safety Signals in Phase II While efficacy was impressive, the trials also raised important safety concerns: Heart rate increases: Mean increases of 7.4 bpm (0.5 mg) and 9.1 bpm (1.0 mg) versus placebo Blood pressure: Modest systolic increases at higher doses Psychiatric effects: Insomnia (2135%), dry mouth (3044%), and mood changes in some patients Gastrointestinal: Nausea, diarrhea, and constipation at rates above placebo The cardiovascular signal particularly the heart rate increase would become the central obstacle in tesofensine's regulatory path

Accordingly, the tissue that is determined as ischemic and therefore studied is differentiated in a manner to which experimenters were blinded