 If the reason for removal of a patient from the study is an adverse event or an abnormal laboratory test results, the principal specific event or test will also be recorded on the Case Report Form. In the event of an emergency when the patients condition requires knowledge of the test treatment, the label may be opened to determine the nature of the test formula dispensed. ANY BROKEN CODE WILL BE CLEARLY JUSTIFIED AND EXPLAINED BY A COMMENT ON THE CASE REPORT FORM, along with the data on which the code was broken. 