Magnetic stainless titanium bracelets are known to possess positive charge. In alternative medicine, pain is considered to have a negative charge. Thus, according to the fundamentals of science, positive charge and negative charge nullify each other. Thus, titanium bracelets relieve pain by neutralizing the electric field.
Pharmacy compounding offers patients customized options for pain medication. Compounding is the art and science of preparing customized medications for patients.
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The FDA has indicated that a single, positive, pivotal efficacy study, in addition to a safety study, will be sufficient for approval under the 505(b)(2) pathway. The Company intends to complete the safety study after completion of the pivotal efficacy study.