If a temperature excursion occurs, the Sponsor should be notified immediately, and the investigational product must be quarantined and maintained under the correct storage conditions until further instructions are provided by the Sponsor. The temperature excursion form will need to be completed and returned to the Sponsor. The original drug receipt form and packing slip must be retained in the Investigator’s pharmacy records. 14.1.4 Toxicity The safety of immunizations (injections) with the ETBX-011, ETBX-051, ETBX-061 has been established in a phase I clinical trial. Ten subjects enrolled and no DLTs were observed.