the patient be hospitalized at an institution with which the study investigator is not 
associated. 
A record will be kept of all patients considered (and screened) for the study and 
subsequently deemed ineligible. The reason for ineligibility must be recorded. 
11.0 DATA COLLECTION AND STUDY MONITORING 
11.1 Data Collection 
Case Report Forms (CRTs) will be utilized for each patient entered into the study. 
Study participants will NOT be identified by name on any study documents. 
Patients will be identified by a patient identification number (PIN). Investigators 
will need to keep a patient code list accessible. 
12.0 BIOSTATISTIC AL CONSIDERATIONS 
The end-points of this study are toxicity, immunological response (cytoxicity, skin test 
immunohistology) and clinical response. 
Patients will serve as their own controls. Pre - and post-treatment values will be 
generated as stem and leaf plots. Statistical tests will be applied to these paired data with 
appropriate confidence intervals and the ability to carry out multiple tests. 
13.0 ETHICAL CONSIDERATIONS 
The investigator will ensure that the study is conducted in full conformance with the 
FDA standards for human research. 
13.1 Informed Consent 
All study participants must sign an informed consent (see Appendix VI). The 
investigators will inform all subjects as to the nature, aims, duration, potential 
hazards, and procedures to be performed during the study and that his or her 
medical records may be reviewed by the sponsors or the FDA. This protocol 
must receive approval by the Institutional Review Board prior to implementation. 
The investigator must also explain that the patients are completely free to refuse 
to enter the study or to withdraw from it at any time. The protocol will be 
discussed in detail with all potentially eligible patients. All revisions of the 
protocol must be reflected in the consent form and reviewed by the IRB. 
13.2 Patient Confidentiality 
All reports and patient samples will be identified only by a coded number to 
maintain patient confidentiality. All records will be kept confidential to the extent 
permitted by law. The investigator should keep a separate log of patients’ codes, 
names, and addresses. Documents which identify the patient by name (informed 
consent) should be kept in strict confidence. 
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