X. RIGHT TO REFUSE OR WITHDRAW: 
Your participation is voluntary and you may refuse to participate, or may discontinue 
participation at any time, without penalty, loss of benefits, or change in your present or 
future care. The investigator also has the right to withdraw you from the study at any time. 
Your withdrawal from the study may be for reasons related solely to you (for example, not 
following study related directions from the investigator or a serious adverse reaction to 
particular procedures) or because the entire study has been terminated. 
XI. OFFER TO ANSWER QUESTIONS: 
You may ask your doctor or the investigators listed above any questions you may 
have about this research study. By signing this form, you agree that the investigator or his 
designee has answered all of your questions. If you have additional questions during the 
course of this study about the research or your rights as a research subject, you may 
address them to the Baylor Institutional Review Board at 713-798-4760. In the event of a 
research-related injury or if any other problems arise, you may contact the Principal Clinical 
Investigator, Dr. Robert Grossman at 713-798-4696 or his designee. 
If you agree to participate in this study, please sign your name below. We suggest you 
retain a copy of this document for future reference and personal records. 
All of my questions have been answered to my satisfaction and I have read the explanation 
about this study and have been given the opportunity to discuss it and to ask questions. I 
hereby consent to take part in this study. 
Because of potential or unknown effects of the study drug on a fetus, if I am a women of 
child-bearing age, I will have a negative serum pregnancy test prior to entry into the study. I 
have been educated and encouraged to the fact that either I or my partner should utilize one 
of the more effective birth control methods during the study and for 3 months after the study 
is concluded. These consist of total abstinence, oral contraceptives, an intrauterine device, 
contraceptive implants under the skin (Norplants) or contraceptive injections. If one of these 
cannot be used, contraceptive foam with a condom is recommended. 
Signature of Patient and Date Signed 
Signature of Investigator and Date Signed 
Signature of Witness & Date Signed 
Recombinant DNA Research, Volume 20 
[747] 
