UNIVERSITY OF CALIFORNIA, SAN DIEGO CONSENT TO ACT AS A RESEARCH SUBJECT

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1 15 pages UNIVERSITY OF CALIFORNIA, SAN DIEGO CONSENT TO ACT AS A RESEARCH SUBJECT MERCK MK-0633 STUDY: A DOUBLE-BLIND, RANDOMIZED, PLACEBO- CONTROLLED, MULTICENTER, PARALLEL GROUP, DOSE-RANGING STUDY OF MK-0633 IN ADULT PATIENTS WITH CHRONIC ASTHMA Stephen Wasserman, M.D., and his associates are conducting a research study to find out more about the safety and tolerability of the research study drug, MK-0633 to see if it improves asthma symptoms. You are being asked to participate because you have chronic asthma. The purpose of this study is find out if MK-0633, an investigational study drug not yet approved by the Food and Drug Administration (FDA), and compared with a placebo (a look-alike pill with no active drug), will help people with chronic asthma problems. The study doctor will be paid by the sponsor, Merck & Co., Inc. for conducting this study. There may be reasons why you are not allowed to take part in this study. The study doctor or staff will discuss this with you. Approximately, 720 people will be in the study participating in about 84 other clinical sites. There will be approximately 16 participants at this site. You will be in the study about nine weeks for nine visits. The study staff will tell you when to come in for your study visits. The visits will usually take place in the morning. There are three phases to the study which are described below: Phase I (run-in period); Phase II (randomization period) and Phase III: Extension Study. You will have the option to continue in the Extension Study an additional 18 weeks (Phase III). A separate consent describing the extension to the study will be provided to you. This is an optional study. If you agree to be in this study, the following will happen to you: If the study doctor says you can be in the study and you want to be in the study, the study doctor will give you study drug to use for about two weeks during the run-in period of the study called Phase I. This is a single-blind run-in period, which means that the study doctor will know, but you will not know, which study drug you will be taking. If you still qualify for the study after the run-in period, you will be assigned by chance (a process similar to flipping a coin called randomization) to receive the study drug in one of the following groups: MK mg MK mg MK mg, OR Merck MK-0633 Consent V2 Page 1 of 15

2 Placebo. After the two-week run-in phase, you will have a one in four chance of getting placebo only. Neither you nor the study doctor will know which of these you are receiving during Phases II and III which is called a double-blind study. In case of an emergency, the study doctor can get this information. There will be a period of time when all participants will receive placebo and no active study drug. At appropriate visits, all subjects will receive three bottles of study drug (labeled A, B, and C), with instructions to take one tablet from each bottle in the evening with food. Bottle A will contain MK mg (or placebo to match), Bottle B will contain MK mg (or placebo to match), and Bottle C will contain MK mg (or placebo to match). In addition, if you agree to participate in this study, you will need to do the following before each visit: Do not participate in strenuous exercise for three days Do not drink alcohol for 24 hours Do not drink any caffeinated beverages for eight hours Do not use any type of medications. The study doctor or staff will discuss this with you. Complete diaries and questionnaires (explained in more detail below) Write down your current caffeinated drink habits. Use two types of birth control throughout the study and for 14 days after the study ends. The study doctor or staff will discuss this with you. Take the study drug(s) as instructed, three pills in the evening with food. Study Visits Visit 1 (This visit will last approximately three hours) Read, review, and sign the informed consent (this document) Complete physical examination including taking your temperature, examining your eyes, ears and mouth, listening to your heart and lungs, feeling your abdomen and looking at your general appearance. Review your asthma history Complete questionnaire on your asthma history Review medications you are currently taking and have taken in the past Review of any asthma related emergencies Electrocardiogram (ECG) test will be performed. An ECG is a test that records the electrical activity of your heart through electrodes (small disks that stick on your body) placed on your chest, arms, and legs. Vital signs will be taken including your height, weight, sitting blood pressure, heart rate, and breathing rate. Spirometry (breathing test): You will be asked to do a breathing test to see how well your lungs are working. For this procedure, you will have to exhale as fast as you can into a Merck MK-0633 Consent V2 Page 2 of 15

3 mouthpiece. This breathing test is one of the criteria that allow you to be part of the study or not. You will be asked to repeat this test a few times. Pregnancy Tests: If you are a woman and can have children, you will have pregnancy tests. The study doctor or study staff will tell you if the pregnancy test results are positive. The results of the pregnancy tests must be negative in order for you to be in the study. This is a blood test. Approximately 1 teaspoon of blood will be taken from your arm. Additional blood and urine tests will be performed. Some of the blood/urine taken during the study will be saved and stored (archived). It will be used only for extra tests related to the study and the study drug. No genetic or DNA testing (analysis of your genes) will be done on these blood samples. Some of these tests will be used to measure if the study drug is working while other tests will be used to monitor your health. Approximately one tablespoon of blood will be drawn throughout the study. An Asthma Action Plan will be provided. This plan will be discussed with you by the study coordinator. It will give you information on what to do or what will be done if your asthma symptoms worsen and you believe that you need additional study drug(s). You will receive diary cards which will be reviewed with you. You will receive albuterol as a rescue medication. Visit 2 (This visit will last approximately two hours) A chest x-ray will be performed unless you have had one within the past year. Give you study drug. Review of previous laboratory work. Asthma Action Plan reviewed. Diary card reviewed and new diary card provided. Albuterol will be provided in case you need it. Visit 3 (This visit will last approximately three hours) Review optional Sputum Consent. If you agree to participate and sign the additional sputum consent, this test will be performed. Review optional Genetic Testing section below in this consent. If you agree to this testing, please check the box and this blood draw will be drawn (less than one tablespoon). Merck MK-0633 Consent V2 Page 3 of 15

4 You will complete an Asthma Quality of Life Questionnaire (AQLQ). This questionnaire will ask multiple-choice questions about your daily activities and health. This will be used to measure the quality of your life as it relates to your asthma. You will complete an Asthma Control Questionnaire (ACQ) which will ask multiple-choice questions about your asthma symptoms and daily activities. This will be used to measure your asthma control. Review your albuterol use since the last visit. Give you study drug and count the returned number of study drug. Pregnancy test will be performed (about 1 teaspoon of blood will be drawn). Plasma sample for assay will be drawn (less than one teaspoon of blood will be drawn). This test must be done on or about 9 am for safety analysis. Plasma sample for archive will be done (less than one teaspoon of blood will be drawn). Plasma biomarkers (blood markers) will be drawn (less than one teaspoon of blood) to look at asthma markers. Urine tests will be performed for safety. Urine test will be performed for archive (storage). Asthma Action Plan reviewed. Diary card reviewed and new diary card provided. Albuterol will be provided in case you need it. Visit 4 (This visit will last approximately 1.5 hours) Review of previous laboratory work. Asthma Action Plan reviewed. Diary card reviewed and new diary card provided. Albuterol will be provided in case you need it. Visit 5 (This visit will last approximately 1.5 hours) ECG will be performed. Blood will be drawn for laboratory safety tests (less than one teaspoon) Merck MK-0633 Consent V2 Page 4 of 15

5 Urine test will be performed. Asthma Action Plan reviewed. Give you study drug and count the returned number of study drug. Diary card reviewed and new diary card provided. Albuterol will be provided in case you need it. Visit 6 (This visit will last approximately two hours) Pregnancy test will be performed (about 1 teaspoon of blood will be drawn). Blood will be drawn for laboratory safety tests (less than one teaspoon) Urine test will be performed. Review laboratory safety tests taken at previous visit. Asthma Action Plan reviewed. Give you study drug and count the returned number of study drug. Diary card reviewed and new diary card provided. Albuterol will be provided in case you need it. Visit 7 (This visit will last approximately 1.5 hours) Review laboratory safety tests taken at previous visit. Asthma Action Plan reviewed. Diary card reviewed and new diary card provided. Albuterol will be provided in case you need it. Visit 8 (This visit will last approximately three hours) (Visits 8 and 10 will occur on same day if you want to participate in the Extension Study) You will complete the questionnaires: AQLQ and ACQ. Review your albuterol use since the last visit. Count the returned number of study drug. Merck MK-0633 Consent V2 Page 5 of 15

6 ECG will be performed. Complete physical exam will be performed. If you agreed to participate in the sputum study, a sputum test will be performed. Pregnancy test will be performed (about 1 teaspoon of blood will be drawn). Plasma sample for assay will be drawn (less than one teaspoon). This test must be done on or about 9 am for safety analysis. Plasma sample for archive will be done (less than one teaspoon will be drawn) Plasma biomarkers will be drawn (less than one teaspoon of blood) Urine tests will be performed Urine test will be performed for archive (storage). Asthma Action Plan reviewed. Diary card reviewed. Visit 9 (This visit will last approximately one hour) Pregnancy test will be performed on all female patients (less than one teaspoon of blood) Review laboratory safety tests from previous visit. Discontinuation Visit If you stop participating in the study before the entire study is completed, you will come to the clinic for a discontinuation visit. The following procedures will be performed. You will complete the questionnaires: AQLQ and ACQ. Review questionnaires. Count returned number of study drug(s). ECG will be performed. A complete physical exam will be performed. Plasma sample for assay will be drawn (less than one teaspoon). This test must be done on or about 9 am. Plasma sample for archive will be done (less than 1 teaspoon) Plasma biomarkers will be drawn (less than one teaspoon) Urine tests will be performed Urine test will be performed for archive (storage). Merck MK-0633 Consent V2 Page 6 of 15

7 For all females, a pregnancy test will be performed two weeks after this visit. Review laboratory safety tests performed at previous visit. Review diary card. If you are a female and capable of child-bearing, your participation requires that you use a birth control method, such as abstinence, diaphragm, condom or intrauterine device to prevent pregnancy during the study, as the study drug being tested may cause harm to an unborn child. If you miss a period or think you might be pregnant, you will notify the doctor. You may have to withdraw from the study. The study doctor will talk to you about birth control methods you must use during the study. Some methods of birth control will not work when you are using certain drugs. Some methods of birth control you may use during this study include: hormonal contraceptives (for example, a patch, an oral contraceptive, or a long-term injectable or implantable hormonal contraceptive) double-barrier methods of birth control (for example, condom plus diaphragm, or condom plus foam, or condom plus sponge) an intrauterine device a history of tubal ligation abstinence from heterosexual intercourse The study doctor will require women who join the study to have pregnancy tests during the study. A pregnancy test does not keep you from becoming pregnant. Genetics Study (Optional Study) You are being asked to provide blood for the analysis of your genes, or DNA, and other components. Information about you will be used for research on how genes and blood components relate to the way that investigational therapies are absorbed, broken down and eliminated from the body, how they affect the body and how DNA relates to human disease. This research may include using study-related or other medications or therapies developed by the Sponsor. Your agreement to provide this blood is optional and entirely up to you. You will receive the same treatment and care under the main study whether or not you decide to provide blood for these analyses. If you decide not to provide your blood or if you withdraw your consent, you will not lose any benefits, medical treatment or legal rights to which you are otherwise entitled. The Sponsor does not wish to identify you in connection with this research, and will use procedures designed to prevent the results of this research from being linked to you. (Please see the "How will information that identifies me be protected?" section below). Where will your blood be stored? People who work for Merck & Co., Inc. will store your blood in a secure laboratory. Your sample will be securely stored, labeled only with a unique sample number, for up to 25 years. At this time, your sample will be physically destroyed. The Sponsor reserves the right to destroy your sample, for any reason, during or after the study. Merck MK-0633 Consent V2 Page 7 of 15

8 Information about you will be collected and shared as described in the main study consent form. Specific measures, as explained below, will be taken to prevent information that identifies you from being associated with your genetic information. If you agree to provide blood, at the time of your blood draw, that sample will be labeled with a unique sample number, known as a 'code' number. The sample will not be labeled with your name. At the beginning of the study, the Sponsor will create a computer file, also known as the "key, that will be used to connect the main study data to the unique code number assigned to your sample. The types of study data that the Sponsor normally collects during the main study include age, gender, race, health conditions, consent and sample date, and laboratory measurements from blood samples. These types of study data are linked with your genetic sample data by the unique code using the key described above. This is done so that the Sponsor is able to study genes and other blood components related to how the drug works in the body. Information that identifies you directly, such as your name, initials, address and phone number, is not associated with your sample for these genetic research studies. Also, no information that identifies you will appear in any research publication. Unless required by law, only the study doctor and staff, sponsor representatives involved in this study, independent ethics committees and inspectors from government regulatory agencies will have the ability to associate information about your genetic sample to your medical records. Under specific circumstances, such as during a regulatory agency or Sponsor audit, information about your genetic sample may be reconnected to your medical records using the key that is maintained by the Sponsor. Once information about you is disclosed to the sponsor, certain privacy laws that apply to the study doctor or institution may no longer protect the information. Also, information about you may be sent from your country to other countries, including countries that don t have laws protecting personal data. The procedures that have been put into place as described above are designed to make it very difficult for the results from genetic research to be linked to you. However, there is always a remote possibility that information from your participation in this study would adversely affect you or your family in some way, such as obtaining employment or health insurance. Can you request that your sample be destroyed? Yes, if you want the Sponsor to destroy your genetic sample, please write a letter stating your request to the doctor or staff member who asked you to participate in the main study. You must make your request in writing. Withdrawing from the main study does not mean your genetic sample will automatically be destroyed. You must make a written request to have your sample destroyed. Merck MK-0633 Consent V2 Page 8 of 15

9 Please send your request to: Stephen Wasserman, M.D. UCSD Clinical Trials Center 210 Dickinson St., CTF-A, Rm. 102, MC8415 San Diego, CA Any analyses in progress at the time of your request or already performed prior to your request being received by the sponsor will continue to be used as part of the overall research. Under certain circumstances, for example if the study site is no longer required by regulatory agencies to keep the main study records, your medical records for this study may be destroyed. If your medical records have been destroyed, there will no longer be a link between your personal information and your genetic sample. If your local medical records are destroyed, you will not be able to request destruction of your genetic sample. Will you get the results of your genetic tests? No, these analyses are done as part of basic research. Basic research analyses are performed under conditions that are different from routine laboratory testing that your doctor may do. Therefore, it would not generally be appropriate for your doctor to use these results as part of your care. The Sponsor also will not provide the genetic analyses to your family, the doctor conducting the main study or any doctor involved in your care, your insurance company or your employer. What are your rights to your DNA sample? Who will have control of it and who will own it? The University has signed an agreement with the sponsor supporting this study. That agreement includes that the blood samples collected in this study, any genetic analyses, and any gene information are the sole property of the Sponsor. The samples collected in this study, any genetic analyses, and any gene information may be used in the development of cell lines, patents, diagnostic tests, drugs, and biological products developed which may be of commercial value to the sponsor (and its successors, licensees, and assignees) and may be used for commercial purposes. There are no plans to share with you any profits that may be earned directly or indirectly as a result of these genetic analyses. Samples for Genetic Testing Please check the appropriate box below and initial: You agree to have samples collected for genetic testing. You do not agree to have samples collected for genetic testing. About The Study Drug(s) MK-0633 has been tested in animals (mice, rats and dogs) at doses higher than those you will be receiving. The side effects noted included: vomiting reflux (burning in the stomach or throat) of drug and damage to the surfaces inside the nose increased drooling Merck MK-0633 Consent V2 Page 9 of 15

10 decreased blood pressure increase in the size of some body organs (adrenal gland, liver, and thyroid) in a few mice and/or rats after 14 weeks of treatment. an increase in the size of a portion of the kidney in a few rats after 27 weeks of treatment a decrease in the size of a portion of the kidney in mice after 4-14 weeks of treatment, that went away after stopping the drug for 4 weeks a decrease in a portion of the male reproductive tract in a few mice after 14 weeks of treatment death at very high doses in rats and mice changes in some blood and urine laboratory tests. You will be checked for these changes during this study. body weight loss occasional abnormal breathing sounds decrease in the size of the uterus (a woman s womb) and the pituitary gland (secretes hormones in the body) in a few rats after 14 weeks of treatment changes in the egg sacs of the ovary (female gland which produces eggs for reproduction) in a few female dogs after 39 weeks of treatment. MK-0633 has also been tested in pregnant female animals (rats and rabbits) at doses higher than those you will be receiving. The side effects noted in the pups included: An increased number of rat pups with an extra rib bone in the neck which can occasionally occur spontaneously. In completed studies To date, a total of 180 healthy subjects have participated in MK-0633 studies, about 144 of the subjects have received MK-0633 as either single doses up to 1000 mg or multiple doses up to 600 mg. Of the 144 healthy subjects that received MK-0633, 20 were elderly women and 14 were elderly men (65 to 80 years of age); of the remaining 110 subjects, 104 were male and 6 were female, 55 years of age or younger. In ongoing/planned studies Currently, a multiple dose study is ongoing in young healthy Japanese males. This study will enroll 27 healthy young men (24 to 44 years). All doses given so far have been safe and generally well tolerated. Risks The following drug related conditions (considered possibly, probably or definitely related to the study drug) have been reported in people to date for MK-0633/placebo studies: headache dizziness pulsating feeling at the head throbbing on both sides of the head difficulty concentrating feeling of warmth Merck MK-0633 Consent V2 Page 10 of 15

11 feeling cold aphtha (similar to a cold sore in the mouth) numb, swollen feeling of the tongue dry eyes or mouth or nose discomfort of the stomach/intestines nausea with vomiting nausea abdominal pain or cramps loose stool constipation borborygmus (rumbling in the stomach) feeling of swollen, heavy legs pulsating and heavy feeling in feet tiredness fatigue sleepiness insomnia or difficulty sleeping small, distinct, flat or raised rash body ache pulse rate increased lightheadedness and dizziness when taking blood pressure measurements in a semi recumbent (lying down) then standing position, increase in heart rate when taking blood pressure measurements in a semirecumbent (lying down) then standing position decrease in blood pressure when taking blood pressure measurements in a semi recumbent (lying down) then standing position decreased white blood cells decreased absolute neutrophil (a type of white blood cells) counts less urine production blood in urine These conditions were considered to be mild to moderate in intensity and not continuous. It is not yet known which volunteers received MK-0633 and which received placebo. We do not know which of these conditions were caused by the study drug. For the placebo, your condition will not be treated, so it may stay the same or worsen. Other less common side effects have been reported. The study doctor or staff can discuss these with you. There may be other side effects or risks that are not known at this time. It is not known whether the study drug(s) may affect an unborn baby. You will be told in a timely manner about significant new information that might affect your decision to stay in the study. Loss of Confidentiality Merck & Co., Inc. will try every effort to maintain the confidentiality of the subject. Merck & Co., Inc and those working in conjunction with Merck & Co., Inc., may use health data to see if the study drug works and is safe and/or to compare the study drug to other drugs and/or for other activities (such as development and regulatory) related to the study drug. When possible, we will not identify the subject Merck MK-0633 Consent V2 Page 11 of 15

12 by name but instead, may use initials, date of birth, and study visit dates. However, the same privacy and confidentiality cannot be guaranteed for other countries and their agencies. Chest X-Ray As a result of participating in this study, if you need to have a chest x-ray, you will be exposed to a small amount of radiation (approximately 0.02 cgy). This amount is less than you would receive from a year of natural exposure, approximately 0.16 cgy. This dose should not be harmful. If you are especially concerned with radiation exposure or you have had a lot of x-rays already, you should discuss this with your doctor. Blood Draw The study doctor or study staff will take your blood by sticking a needle in your arm. Some problems you might have from this are: It may hurt. You may get a bruise or some swelling. You may feel dizzy and/or faint. You may get an infection. Breathing tests Some people experience shortness of breath and dizziness from performing breathing tests. Every effort will be made to minimize these risks. Taking your blood pressure You may have bruising on your arm from the blood pressure cuff. ECG testing ECG patches may cause skin redness or itching. Loss of Confidentiality: Genetic Study To protect your privacy, blood samples and medical information will be labeled (or coded ) with your study subject number, not a name. Only the study doctor and his or her staff will keep the link between the subject number and your name. Any results from this pharmacogenetic study will not be placed in your medical records. Merck & Co., Inc. has taken appropriate measures to ensure the confidentiality of the research-related information. However, if you pass on your results (if obtained by you), there is a possibility that this could have an effect on your insurance or employment. This risk is similar as if you were to disclose any type of personal medical information to a third party. Medical information, samples and research results from you and other research participants may be studied by Merck & Co., Inc. to make medicines or tests to determine the body s response to or handling of medicine. That information and any results will be put in a computer and stored in electronic databases. International regulations for information on computers and relevant laws on processing personal information will be strictly adhered to. Your information, sample, and results Merck MK-0633 Consent V2 Page 12 of 15

13 could be sent to other researchers working with Merck & Co., Inc. and to other Merck & Co., Inc. sites. Benefits There may or may not be any direct benefit to you from these procedures. The investigator, however, may learn more about helping people with moderate to severe chronic asthma. Compensation You will be reimbursed for your time and travel up to $ for participating in this research as follows: Visit 1 $75 Visit 4 $100 Visit 7 $50 Discontinuation $50 Visit 2 $50 Visit 5 $50 Visit 8 $100 Visit 3 $100 Visit 6 $50 Visit 9 $20 If you do not complete all of the visits, you will be reimbursed for the visits that you have completed. Injury Clause If you are injured as a direct result of participation in this research, the University of California will provide any medical care needed to treat those injuries at no cost to you. Neither the University nor Merck, Inc., will provide any other form of compensation if you are injured. You may call the UCSD Human Research Protections Program office at (858) for more information about this, to inquire about your rights as a research subject, or to report research-related problems. has explained this study to you and answered your questions. If you have other questions or research-related problems, you may reach (619) during regular business hours. Alternatives to Study Drug The alternatives to using the study drug and participation in this study are listed as follows. The study doctor can discuss these options with you. inhaled corticosteroids such as beclomethasone (Vanceril ), budesonide (Pulmicort ), flunisolide (Aerobid ), fluticasone (Flovent ), and triamcinolone (Azmacort ) theophylline (Slo-bid ) oral and long acting inhaled beta-adrenergic agonists such as salmeterol (Serevent ) fixed dose combinations of inhaled corticosteroids and long acting beta-adrenergic agonists such as fluticasone/salmeterol (Advair ) oral and short acting inhaled beta-adrenergic agonists such as albuterol and salbutamol oral leukotriene receptor antagonists such as montelukast (Singulair ) and zafirlukast (Accolate ) Participation in research is entirely voluntary. You may refuse to participate or withdraw at any time without jeopardy to the medical care you will receive at this institution. Merck MK-0633 Consent V2 Page 13 of 15

14 Confidentiality Study personnel will treat your identity with professional standards of confidentiality. If you decide to be in this study, the study doctor and research team will use health data about you to conduct this study, as described in the main consent. This may include your name, address, phone number, medical history, and information from your study visits. This health data may come from your family doctor or other health care workers. For this study, the research team will share health data about you with government agencies and ethics committees that oversee the research. It will also be shared with the Sponsor and those working for the Sponsor. People who work for the Sponsor to make sure the study rules are followed will be able to see all health data about you at the study site. When possible, the health data that is sent to the Sponsor and those working for the Sponsor will not identify you by name. Instead, it may include your initials, date of birth, and study visit dates. If you think that you were harmed from being in the study, the research team may also share health data about you with the Sponsor s insurer to resolve your claim. The Sponsor and those working for the Sponsor may use the health data sent to them: to see if the study drug works and is safe; to compare the study drug to other drugs; for other activities (such as development and regulatory) related to the study drug. For these uses, the Sponsor may share this with others involved in these activities, as long as they agree to only use the health data as described here. Once the research team shares health data about you with others, Federal privacy law may no longer protect it. Your permission to use and share health data about you will not end. You may take away your permission to use and share health data about you at any time by writing to the study doctor. If you do this, you will not be able to stay in this study. No new health data that identifies you will be gathered after that date. However, health data about you that has already been gathered may still be used and given to others as described in this consent form. You may request this data. Discontinuation from the Study You may voluntarily withdraw from the study at any time. Your decision to withdraw will involve no penalty or loss of benefits to which you would otherwise be entitled. You should notify the study doctor or study personnel if you choose to discontinue from the study. The study doctor will ask you to have some end-of-study tests. Your participation in the study may be terminated with or without your consent for any of the following reasons: Failure to follow the investigator s instructions. Merck MK-0633 Consent V2 Page 14 of 15

15 A serious reaction, which may require evaluation. If the investigator feels it is in the best interest of your health and welfare. The sponsor, Merck & Co., Inc., terminates the study. Pregnancy. Any other reason. Consent Statement You have read and been informed about all the information in this consent form. You have been given the chance to discuss it and ask questions. All your questions have been answered to your satisfaction. You voluntarily consent to take part in this study. You will receive a signed copy of this consent form and a copy of the Experimental Subject s Bill of Rights to keep. By signing this consent form, you have not given up any of the legal rights which you otherwise would have as a subject in a research study. Signature of Subject Date of Signature Printed name of Subject Signature of Person Administering this Consent Date of Signature Printed Name of Person Administering this Consent Merck MK-0633 Consent V2 Page 15 of 15