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INFORMED CONSENT FORM PROJECT PRI-P2-414 (Sponsor Project N PKH-05151-002) A SINGLE DOSE CROSSOVER COMPARATIVE BIOAVAILABILITY STUDY TO ASSESS DRUG INTERACTION BETWEEN PERINDOPRIL ARGININE, ATORVASTATIN AND ACETYLSALICYLIC ACID FOLLOWING THE FREE COMBINED VERSUS THE INDIVIDUAL ADMINISTRATIONS OF PERINDOPRIL ARGININE 10 mg, ATORVASTATIN 40 mg AND ACETYLSALICYLIC ACID 100 mg TABLETS IN HEALTHY MALE VOLUNTEERS FASTING STATE

* Ce document est galement disponible en franais et me sera offert sur demande.

Volunteers full name: _________________________________ Principal Investigator: Eric Sicard, M.D., Algorithme Pharma Inc. Introduction

Code: __________________

You are invited to take part in a research study on perindopril arginine, atorvastatin and acetylsalicylic acid. Perindopril arginine reduces blood pressure and is indicated in the treatment of hypertension (high blood pressure). Atorvastatin is indicated for the reduction of cholesterol and acetylsalicylic acid is used to prevent blood clots and reduce the risk of heart attack. The recommended starting dose of perindopril arginine is 5 mg given once daily and the maximal dose administered to patient is 10 mg once daily. The usual recommended starting dose of atorvastatin ranges between 10 mg and 40 mg once daily. The maximal dose of atorvastatin is 80 mg once daily. For acetylsalicylic acid, the usual dose administered to patients ranges between 80 mg and 325 mg once a day. There is no contraindication to administer these 3 medications at the same time. Objective The main objective of this study is to show that the amount of each drug (perindopril (10 mg), atorvastatin (40 mg) and acetylsalicylic acid (100 mg)) found in your blood is not affected when co-administered or administered alone. These tablets are manufactured by 3 different companies and are currently being sold in Europe. General Procedure of the Study This study will be conducted at one clinical site and will involve approximately 96 male subjects based on the current study design. This study is divided into 4 clinical periods which will run approximately 21 days apart. This procedure ensures that the drug taken at the previous period is not present in a detectable concentration in your blood at the beginning of the next period of the study. Each period corresponds to the single oral dose administration, in random order (administration of the drugs in no specific order), of one of the 4 following treatments:
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1) One tablet of perindopril arginine 10 mg, one tablet of atorvastatin 40 mg and one tablet of acetylsalicylic acid 100 mg administered together. 2) One tablet of perindopril arginine 10 mg. 3) One tablet of atorvastatin 40 mg. 4) One tablet of acetylsalicylic acid 100 mg. Each period will last approximately 82 hours (about 3 days) following the administration of treatment 1, 2 and, 3 and approximately 18 hours following the administration of treatment 4. For each period of the study, you should arrive at the clinical site at the latest at 19:30 in the evening before drug administration and you will stay until 36 hours after the administration of treatment 1, 2 and 3, and 8 hours after the administration of treatment 4. However, for your safety, you will be advised to remain at the clinical site for a longer period if significant side effects are present according to the judgment of the physician in charge. If you have received treatment 1, 2 or 3, you will be required to return to the clinical site at least 20 minutes before each of the remaining 2 blood samples. No return visit is necessary following the administration of treatment 4. The total length of the study will be approximately 68 days not including the screening period. Screening Tests In the 28 days prior to the beginning of the study, you will undergo a medical examination, laboratory tests (hematology, biochemistry and urinalysis) including HIV, Hepatitis B and Hepatitis C tests and an electrocardiogram (ECG: test that measures the electrical activity of your heart). Your blood pressure, your pulse rate and your body temperature will also be measured. In addition, a screening test to detect alcohol and drugs (such as: cocaine, opiates, cannabis, barbiturate, phencyclidine and amphetamine) in urine will be done in the 28 days preceding the study. To avoid false positive results to opiate drugs, you should refrain from consuming all products containing poppy seeds for 48 hours before the screening tests. If the test results are normal, you may be selected to participate in this study. Medication, Alcohol, Food and Other Restrictions Only healthy volunteers who meet specific inclusion criteria may participate in the present clinical study. If you must take medication as recommended by your physician because of your health condition and if this medication is included in the following restrictions, it is strongly recommended to take your medication for your well-being, even if it means that you will not be allowed to participate in this study or that you will have to discontinue your participation in this study. The following medications are not allowed in the 28 days prior to the first drug administration and throughout the duration of the entire study (68 days): potassium sparing diuretics (e.g. Aldactone, Dyrenium), potassium supplements, potassium-containing salt substitutes, lithium salts, any drug known to increase the risk of muscle weakness (e.g., gemfibrozil, fenofibrate, niacin) and enzyme-modifying drugs like barbiturates (e.g., Phenobarbital), corticosteroids (e.g., Hydrocortisone, Prednisone, Dexamethasone), antidepressants (e.g., Prozac), antiepileptic agents like Dilantin, Tegretol or Epival, antibiotics like erythromycin (Eryc), clarithromycin (Biaxin), azithromycin (Zithromax), ciprofloxacin (Cipro) or rifampin (Rifadin), anti-fungus agents like Nizoral, Sporanox or Diflucan, antiarrhythmic agents like quinidine bisulfate, antacid agents like cimetidine, antihypertensive agents like diltiazem (Cardizem) as well as St-Johns Wort.

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The following medications are not allowed in the 28 days prior to the first drug administration and throughout the duration of the entire study (68 days): any prescription drugs. The following medications are not allowed in the 14 days prior to the first drug administration and throughout the duration of the entire study (68 days): any drugs you can buy without a prescription like acetylsalicylic acid (e.g., Aspirin), acetaminophen (e.g., Tylenol, Atasol), anti-inflammatory drugs (e.g., Motrin, Advil), antacids (e.g., Maalox, Pepcid), vitamins (e.g., Centrum), decongestants (e.g., Contac, Sudafed), cough syrup (e.g., Benylin DM, Balminil) and natural products used for therapeutic benefits (e.g., Ginseng, Echinacea). In the 7 days prior to each drug administration and throughout each study period, you must refrain from consuming pomelo and/or grapefruit-containing beverages and food. For 58 hours before each drug administration and throughout each study period, you must refrain from consuming alcohol and all products containing xanthines (coffee, tea, chocolate, cola beverages and energy drinks such as Red Bull and Guru). Throughout the duration of the entire study, a maximum of 10 cigarettes per day will be permitted. However, due to clinical activities, you will have to abstain from smoking for at least 2 hours before each drug administration until at least 4 hours after each drug administration. You will be questioned about these restrictions at your arrival on the clinical site. During each period of the study, bathrooms may be locked for at least 4 hours after each drug administration. If necessary, you will be permitted to use the washroom facilities under supervision only during this interval. Drug Administration In each period of the study, a single dose of one of the following treatments will be administered orally (within one minute) to you with 240 mL of water (approximately 1 cup) in the morning: 1) One tablet of perindopril arginine 10 mg, one tablet of atorvastatin 40 mg and one tablet of acetylsalicylic acid 100 mg administered together. 2) One tablet of perindopril arginine 10 mg. 3) One tablet of atorvastatin 40 mg. 4) One tablet of acetylsalicylic acid 100 mg The tablet(s) must be swallowed whole and must not be chewed or broken. You will not be allowed to drink anything else from at least 1 hour before the treatment administration until at least 1 hour after. Water will be allowed as you desire after that. Immediately after the treatment administration, you will show your hands and open your mouth to let us verify closely if you swallowed the medication. For your safety, you will remain seated for at least the first 4 hours following the drug administration. You will not be allowed to sleep or to lie down. However, should adverse events occur at any time, you

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may be placed in an appropriate position for you safety. After this 4-hour period, you may get up, but only under supervision. These procedures will be the same for each period of the study. Meals during study During each period of the study, you will be asked to fast for approximately 14 hours, i.e., 10 hours before the administration of the treatment until approximately 4 hours after the treatment administration, at which time a lunch will be served. For Treatments-1, -2 and -3, a supper, a light snack and other meals will also be served at appropriate times thereafter. You must eat all the contents of your meals. Tests During Study A screening test to detect alcohol and drugs (such as: cocaine, opiates, cannabis, barbiturates, phencyclidine and amphetamines) in urine will be performed before each study period. It may also be performed during each study period. To avoid false positive results to opiate drugs, you should refrain from consuming all products containing poppy seeds for 58 hours before each drug administration and throughout each study period. Vital signs (blood pressure, pulse rate and body temperature) will be measured prior to each treatment administration. Based on exclusion criteria, your blood pressure must be equal or higher than 105/60 mmHg before each drug administration. If not, you will be excluded from the study for your safety. Your blood pressure and your pulse rate will also be measured during the study, i.e., 6 times after Treatments-1, -2 and -3, and 4 times after Treatment-4. Laboratory tests (hematology) will be repeated before the 4th period of the study. These tests are performed for your safety. However, depending on the results, you could be excluded from the study; in which case a member of the medical staff will indicate to you the procedure to follow. Blood Sampling For Treatment-1: A total of sixty-four (64) blood samples will be collected on 30 occasions by a catheter (flexible tube) that will be inserted in your arm. Blood draws could be also performed by introducing a needle into a vein of your arm. The first blood draw (3 x 4 mL, approximately 3 teaspoons) will be collected prior to the administration of the treatment. All other blood draws (1, 2 or 3 x 4 mL each, approximately 1, 2 or 3 teaspoons each) will be collected following treatment administration. The blood sampling schedule will be as follows:

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Research Project PRI-P2-414 Sponsor Project N PKH-05151-002 Interval (hours post-dose) 0-24 25-48 49-72 Number of blood samples 58 4 2

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For Treatment-2: A total of twenty-three (23) blood samples will be collected by a catheter (flexible tube) that will be inserted in your arm. Blood draws could be also performed by introducing a needle into a vein of your arm. The first blood draw (1 x 4 mL, approximately 1 teaspoon) will be collected prior to the administration of the treatment. All other blood draws (1 x 4 mL each, approximately 1 teaspoon each) will be collected following treatment administration. The blood sampling schedule will be as follows: Interval (hours post-dose) 0-24 25-48 49-72 Number of blood samples 20 2 1

For Treatment-3: A total of twenty-three (23) blood samples will be collected by a catheter (flexible tube) that will be inserted in your arm. Blood draws could be also performed by introducing a needle into a vein of your arm. The first blood draw (1 x 4 mL, approximately 1 teaspoon) will be collected prior to the administration of the treatment. All other blood draws (1 x 4 mL each, approximately 1 teaspoon each) will be collected following treatment administration. The blood sampling schedule will be as follows: Interval (hours post-dose) 0-24 25-48 49-72 Number of blood samples 20 2 1

For Treatment-4: A total of eighteen (18) blood samples will be collected by a catheter (flexible tube) that will be inserted in your arm. Blood draws could be also performed by introducing a needle into a vein of your arm. The first blood draw (1 x 4 mL, approximately 1 teaspoon) will be collected prior to the administration of the treatment. All other blood draws (1 x 4 mL each, approximately 1 teaspoon each) will be collected following treatment administration. The blood sampling schedule will be as follows: Interval (hours post-dose) 0-8 Number of blood samples 18

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We intend to analyze each sample in order to measure the amount of the corresponding medication present in your blood and to compare the four treatments. The total volume of blood drawn over an approximate 68-day period, including the volume necessary for the laboratory tests, should not exceed 532 mL per subject. By comparison, a blood donation to Hema-Quebec is about 450-500 mL collected over an average time of 20-30 minutes and can be repeated every 56 days. Post-study Tests For your safety, after the collection of the last blood sample of the study, you will undergo laboratory tests (hematology, biochemistry and urinalysis) and an electrocardiogram (ECG: test that measures the electrical activity of your heart). In addition you may undergo a physical examination, if judged necessary by the physician in charge. Therefore, your last return visit should last approximately 1 hour. If the results of your post-study tests are judged abnormal, the physician in charge will ask you to come back for a medical follow-up.

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Research Project PRI-P2-414 Sponsor Project N PKH-05151-002 Risks and disadvantages of this study Perindopril arginine:

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Beside the common adverse reactions (like pain, bruising, redness at sampling site) or uncommon adverse reactions (bleeding from the sampling site, formation of a small blood clot or swelling of the vein and surrounding tissues, fainting) related to the multiple blood samplings, the most frequent side effects that have been reported after the administration of perindopril arginine are the following (frequent adverse events are those occurring in at least 1% but less than 10% of patients). All the adverse events listed are presented from the most frequent to the least frequent; top to bottom, left to right: It is important to emphasize that, although the events reported occurred during treatment with perindopril arginine, they were not necessarily caused by it.

Headache Dizziness Vertigo Tingling Vision disturbance Ringing in the ears Low blood pressure

Cough Breathing difficulty Nausea Vomiting Abdominal pain Abnormal taste Abdominal discomfort

Diarrhea Constipation Skin rash Itching Muscle cramps Weakness

The following rare, potentially fatal, adverse reactions could occur in patients treated with perindopril arginine. It is important to emphasize that, although the events reported occurred during treatment with perindopril arginine, they were not necessarily caused by it. If you are at the clinical site and notice any of the signs or symptoms mentioned below, check with the staff in the clinic immediately. However, if you are no longer at the clinical site and notice any of the signs or symptoms mentioned below, dial 9-1-1 or go immediately to the nearest hospital. It is not recommended that you drive to the hospital yourself. As soon as you can, dial the 24-hour emergency phone number (514) 410-6882 Pager (a nurse will call you back as soon as possible) to inform us of your health status.

Vascular and heart problems including stroke (sudden loss of consciousness, sensation, and voluntary motion caused by a blood clot in the brain), severe hypotension/low blood pressure (characterized by dizziness and fatigue), angina (characterized by chest pain), abnormal cardiac rhythm (characterized by an unpleasant awareness of your own heartbeat; the heart may beat too fast, too slow, or with an irregular pattern) and heart attack (the heart loses its ability to pump blood efficiently, characterized by chest pain and shortness of breath. Severe decrease in kidney function, which can lead to kidney failure, characterized by decreased volume of urine, fatigue, swelling of the extremities or decreased appetite. Liver inflammation (hepatitis), which can lead to liver failure, characterized by dark urine, loss of appetite, fatigue, abdominal pain, yellow coloring of the skin, nausea, vomiting, fever, or weight loss. Pancreatitis (inflammation of the pancreas) characterized by intense abdominal pain and vomiting. Severe skin lesions.

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Allergic reactions (mild to severe) such as angioedema characterized by swollen mouth, lips, tongue, eyes, throat or difficulty in swallowing or breathing.

Cases of death have been reported in patients using perindopril arginine due to sudden cardiac arrest or hepatic failure. Rare cases of loss of cells in the blood or bone marrow, such as white blood cells (agranulocytosis characterized by fever, sore throat, skin rash and ulcers in the mouth), red blood cells (anemia characterized by fatigue, pale skin color, increased heart rate, shortness of breath, weakness or muscle pain), platelets (unusual bleeding or bruising) or neutrophils (risk of infection). If you notice any of these signs or symptoms, check with the staff in the clinic immediately or go immediately to the nearest hospital. Other side effects are reported but are usually associated with long term use, drug interaction, higher dose and/or the presence of disease. A list of these side effects is available at the clinical site if you want to know more about them. There is a higher risk of infection (such as cold, flu and gastroenteritis) during your stay in the clinic owing to the presence of a large number of people. Subjects who develop dizziness, confusion, somnolence or fatigue should be warned against engaging in hazardous activities (like driving a car or operating machinery) requiring mental alertness and motor coordination in the first 6 days following each drug administration If you do not understand the meaning of any of the side effects mentioned above, please ask the study doctor or a clinical staff member to explain these terms to you.

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Research Project PRI-P2-414 Sponsor Project N PKH-05151-002 Atorvastatin

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The most frequent side effects that have been reported after the administration of atorvastatin are the following (frequent adverse events are those occurring in at least 1% but less than 10% of patients). All the adverse events listed are presented from the most frequent to the least frequent; top to bottom, left to right: It is important to emphasize that, although the events reported occurred during treatment with atorvastatin, they were not necessarily caused by it.

Inflammation of the nose and the throat (nasopharyngitis) Weakness Diarrhea Headache Pain (extremities, muscles, throat and joints)

Excess of sugar in the blood Abdominal discomfort Abnormal laboratory results (liver enzymes) Nausea Constipation Muscle spasms

Joint swelling Nosebleed Flatulence (gas) Depression

The following rare, potentially fatal, adverse reactions could occur in patients treated with atorvastatin. It is important to emphasize that, although the events reported occurred during treatment with aorvastatin, they were not necessarily caused by it. If you are at the clinical site and notice any of the signs or symptoms mentioned below, check with the staff in the clinic immediately. However, if you are no longer at the clinical site and notice any of the signs or symptoms mentioned below, dial 9-1-1 or go immediately to the nearest hospital. It is not recommended that you drive to the hospital yourself. As soon as you can, dial the 24-hour emergency phone number (514) 410-6882 Pager (a nurse will call you back as soon as possible) to inform us of your health status.

Heart problem including angina (characterized by chest pain). Severe muscle disease with or without rhabdomyolysis (muscular side effect characterized by pain, mainly in the lower back and calves, unexplained muscle pain or weakness, fatigue, joint pain, weight gain and dark urine). In some cases, rhabdomyolisis can lead to renal disorders. Liver inflammation (hepatitis) characterized by dark urine, loss of appetite, fatigue, abdominal pain, yellow coloring of the skin, nausea, vomiting, fever, or weight loss. Pancreatitis (inflammation of the pancreas) characterized by intense abdominal pain and vomiting. Severe skin lesions. Allergic reactions (mild to severe) such as angioedema characterized by swollen mouth, lips, tongue, eyes, throat or difficulty in swallowing or breathing.

Rare cases of loss of cells in the blood or bone marrow, such as white blood cells (agranulocytosis characterized by fever, sore throat, skin rash and ulcers in the mouth) or platelets (unusual bleeding or bruising). If you notice any of these signs or symptoms, check with the staff in the clinic immediately or go immediately to the nearest hospital. It is not recommended that you drive to the hospital yourself.

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Other side effects are reported but are usually associated with long term use, drug interaction, higher dose and/or the presence of disease. A list of these side effects is available at the clinical site if you want to know more about them. There is a higher risk of infection (such as cold, flu and gastroenteritis) during your stay in the clinic owing to the presence of a large number of people. Since atorvastatin can cause photosensitivity, you may become more sensitive to sunlight than you are normally and exposure to sunlight may cause severe sunburn or skin rash. It is, therefore, strongly recommended to stay out of direct sunlight, to avoid the use of a sunlamp or tanning bed, to wear protective clothing, and to use a sun block preparation (SPF 30) during the first 24 hours following each drug administration. If you do not understand the meaning of any of the side effects mentioned above, please ask the study doctor or a clinical staff member to explain these terms to you.

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Research Project PRI-P2-414 Sponsor Project N PKH-05151-002 Acetylsalicylic acid

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The most frequent side effects that have been reported after the administration of acetylsalicylic acid are the following: It is important to emphasize that, although the events reported occurred during treatment with acetylsalicylic acid, they were not necessarily caused by it.

Nausea Vomiting Diarrhea Gastrointestinal bleeding and/or ulcers

Abdominal pain and discomfort Heartburn (gastric reflux) Urticaria Skin rash

Asthma Ringing in the ears Sweating

The following rare, potentially fatal, adverse reactions could occur in patients treated with acetylsalicylic acid. It is important to emphasize that, although the events reported occurred during treatment with acetylsalicylic acid, they were not necessarily caused by it. If you are at the clinical site and notice any of the signs or symptoms mentioned below, check with the staff in the clinic immediately. However, if you are no longer at the clinical site and notice any of the signs or symptoms mentioned below, dial 9-1-1 or go immediately to the nearest hospital. It is not recommended that you drive to the hospital yourself. As soon as you can, dial the 24-hour emergency phone number (514) 410-6882 Pager (a nurse will call you back as soon as possible) to inform us of your health status.

Severe decrease in liver function, which can lead to liver failure, characterized by nausea, fatigue, drowsiness, weakness, loss of appetite, skin itching, yellow coloring of skin or eyes, stomach pain or flu-like symptoms. Severe skin lesions. Gastrointestinal disorders such as stomach ulcers, intestinal perforation and hemorrhage, characterized by pain in your stomach, abdominal pain, nausea or vomiting may occur with acetylsalicylic acid. Allergic reactions (mild to severe) such as angioedema characterized by swollen mouth, lips, tongue, eyes, throat or difficulty in swallowing or breathing.

The acetylsalicylic acid should not be used in young adult with flu symptoms since it could lead to the development of the Reye's syndrome (characterized by vomiting, fatigue, drowsiness, combative behavior, confusion, delirium, convulsion and coma). Rare cases of loss of cells in the blood or bone marrow, such as white blood cells (agranulocytosis characterized by fever, sore throat, skin rash and ulcers in the mouth), red blood cells (anemia characterized by fatigue, pale skin colour, increased heart rate, shortness of breath, weakness or muscle pain), platelets (unusual bleeding or bruising) or neutrophils (risk of infection) have been reported in patients taking acetylsalicylic acid. If you notice any of these signs or symptoms, check with the staff in the clinic immediately or go immediately to the nearest hospital.

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Hearing loss (usually completely reversible) has been reported in patients taking acetylsalicylic acid. Acetylsalicylic acid (aspirin) may cause an increased bleeding tendency (important bleeding) during and after surgery (including minor surgery, e.g.: tooth extraction). Other side effects are reported but are usually associated with long term use, drug interaction, higher dose and/or the presence of disease. A list of these side effects is available at the clinical site if you want to know more about them. There is a higher risk of infection (such as cold, flu and gastroenteritis) during your stay in the clinic owing to the presence of a large number of people. If you do not understand the meaning of any of the side effects mentioned above, please ask the study doctor or a clinical staff member to explain these terms to you.

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Research Project PRI-P2-414 Sponsor Project N PKH-05151-002 Benefit

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As you do not need any treatment with the present drugs, this study will not provide you any direct advantage or medical benefit, except that you will have a study-related medical evaluation. However, the results of this study may be useful to people using these products. Voluntary Participation Participation in this study is entirely voluntary; you are not obliged to take part. Refusal to participate will not affect any benefits to which you are otherwise entitled. If you decide to take part, you will have to sign this form to confirm that you have given your consent to participate. You will be given a copy of this informed consent document. If you agree to participate, you may nevertheless withdraw from the study at any time, although for your own safety you should inform a member of the clinical staff of Algorithme Pharma. You know that expected or unexpected adverse reactions may occur during the course of this study and you are aware that no guarantee can be provided that these reactions will not occur. During the conduct of this study, you will be advised of any new available information regarding the drugs under study that may modify your desire to participate in this study. If you withdraw your consent or if you are withdrawn from the study, further evaluations may be performed to monitor your safety, in addition to the post-study tests. The Sponsor and Algorithme Pharma Inc. will retain and may continue to use data derived and samples collected before your withdrawal. Blood Donation You must refrain from: - donating more than 49 mL of your blood (Hma-Quebec or other) in the previous 28 days before day 1 of the study, - donating more than 499 mL of your blood (Hma-Quebec or other) in the previous 56 days before day 1 of the study, and - any blood donation during the total length of the current study, except for the blood draws required for this study. You must also refrain from participating in another clinical study in the previous 28 days before day 1 of the study and during the total length of the current study. Because of the volume of blood collected, during the present study, it is recommended that you maintain a healthy diet and eat foods rich in iron such as meat, green vegetables, enriched cereals and eggs. It is also recommended that you wait until 56 days after the last day of the study before donating blood. Contact Numbers For the duration of the study, you must notify the physician in charge of the study or designee of any medical treatment that may be necessary for you to undergo.

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For all questions related to the study (test results, information about a side effect, notifications of late arrivals or no show, a procedure or any other points), you should dial the following phone number during working hours; your call will be appropriately directed: Study-Related Questions: (514) 381-2546 (Montreal) 1-888-758-6312 (Outside) The working hours are Monday to Friday between 08:00 and 20:00. Outside these hours, messages will be followed-up as soon as possible. For a medical emergency or if you experience any expected or unexpected adverse reactions during the course of this study and until 12 days after your last blood sample of the study, you must immediately dial the 24-hour emergency phone number below. A nurse will call you back as soon as possible. Medical-Related Emergency: (514) 410-6882 Pager

If any adverse reactions occur outside the clinical site and you are unable to reach us, you should go to the nearest convenient hospital. However, it is not recommended that you drive there yourself. You may also consult your attending physician at any time during this study. For questions strictly related to your rights as a study subject, you may contact Mr. Guy Beauregard at (514) 382-4434, who is a member of the research ethics committee ETHIPRO. This ethics committee is independent of Algorithme Pharma. It is in charge of reviewing and approving all relevant study documents. Procedures in case of prejudice If you become ill or if you are injured as a direct result of being in this study (like side effects or procedure used in the study), medical treatment will be provided to you at no cost by a designated nurse or physician. Other than the indemnity received for your participation in this study, you are aware that no other financial compensation will be offered to you. However, you understand that you have not waived any of your rights by signing this form. Confidentiality You agree that results of the study may be passed on to the appropriate authorities, to the sponsor, and to the manufacturer of the drug under study. All essential documents and records will be maintained at Algorithme Pharma for a period of at least 25 years. Your name and address will be kept confidential. Sponsor or representatives of the sponsor, institutional review board, or local or foreign regulatory authorities (such as Health Canada, the Food and Drug Administration and the European Medicines Agency) may wish to examine your records to verify the information collected during the screening tests and throughout the study. By signing the consent form, you give permission for this review of your records. They all subscribe to a strict confidentiality policy. You also consent to the verification by the personnel of Algorithme Pharma of your eligibility to participate in this study with other clinical research establishments and to the disclosure of the information concerning your participation in studies at Algorithme Pharma to those establishments.

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Research Project PRI-P2-414 Sponsor Project N PKH-05151-002 Indemnity

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You are aware that, if you complete the study, the global compensation for your participation will be $2550.00. According to clinical rules and during each period of the study, you will receive a sum of money at predetermined moments, during your visits to the clinical site (including returns, if applicable) and the balance will be given to you after the end of the study. On the other hand, if you leave or are discharged from the study before the scheduled end (even for medical or scientific reasons), you will be compensated for the percentage of the study that you have completed.

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Research Project PRI-P2-414 Sponsor Project N PKH-05151-002 INFORMED CONSENT

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I am aware of the types of drugs that will be administered during the course of this study, the duration of the study, the doses and the route of administration and the method of blood sampling to be employed. I am aware of the nature of this study and the probable risks that may arise upon the administration of these drugs during the course of a study, such as the present one. I have been informed of the rules to follow regarding alcohol, food and drug consumption. Therefore, if there are any doubts regarding my soberness, I will be tested for alcohol or drugs. If the result of any of these tests is positive, the physician in charge of the study or designee will personally inform me and at that moment, he will indicate the procedure to follow. The results will remain confidential in accordance with the law. I am also aware that HIV, Hepatitis B and Hepatitis C tests will be performed. If the result of any of these tests is positive, the physician in charge of the study or designee will also personally inform me and at that moment, he will indicate the procedure to follow. A positive result for Hepatitis B, Hepatitis C or HIV will be reported by the physician in charge of the study or designee to the public health department as required by law. I understand that I must keep my scheduled appointments because this is important for the success of the study. I also understand the rules of Algorithme Pharma and I agree to follow them during the total length of the study. My failure to do so may result in my disqualification as a subject in this study. I understand that the study can be cancelled or delayed (hours, days or weeks) at any time even if all screening tests for this study were successfully completed. I understand that I will not be compensated for any delay or cancellation occurring before the administration of the first dose of this study. I have read the informed consent form for this study and I have received explanations about the nature, purpose, duration, foreseeable effects and risks of the study and of what I will be expected to do. All my questions have been answered to my satisfaction and I voluntarily consent to participate in the proposed study. Nonetheless, I understand that if I decide not to be in the study or if I end my participation at any time during the study, I will not be penalized or lose any benefits I would otherwise receive. If I want to leave the study, I will contact the physician or one of his designees who will tell me what I need to do before leaving. On the other hand, I understand that the physician in charge of the study or designee, Algorithme Pharma or the Sponsor may end my participation at any time, without my consent, because of adverse events, scientific reasons, administrative reason, or a noncompliance to the procedures or restrictions (like taking alcohol and/or any drugs including recreational drugs, not respecting your appointments, being uncooperative in act or in speech (impoliteness and higher than normal tone of voice)); if I leave or am discharged from the study before the scheduled end, I will be compensated for the percentage of the study that I have completed. I am at least 18 years old and I have the legal capacity to sign this informed consent form. I answered honestly and clearly to the questions and I am aware that if I have not been completely truthful regarding my health history, if I have not informed the medical staff about my participation in any other clinical studies and if I do not fully comply with the directions given to me, I may harm myself or jeopardize the health of others by participating in this study.

2012/12/20 Subject initials

FINAL AND APPROVED BY ETHIPRO

Research Project PRI-P2-414 Sponsor Project N PKH-05151-002

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I have been informed that Algorithme Pharma is not involved in the fabrication of the drugs under study and I recognize that the present study is strictly for research purposes. I carefully read the document entitled "Informed Consent Form" and I recognize receiving a signed copy of this document. I will acknowledge receiving the compensation to which I am allowed.

Volunteers full name: _________________________________________________________________

(in block letters)

Signature: _____________________________

Date: |__|__|__|__| |__|__| |__|__|

Y Y Y Y M M D D (To be completed by the subject at the time of consent)

Physician in charge of the study or designee I confirm that I have personally explained the nature, purpose, duration and foreseeable effects and risks of the study to the subject named above. I also confirm the identity of the subject named above.

Question: I confirm that the ICF process was conducted, and subject signature obtained, prior to any screening procedures: YES NO

Physician or designees full name: _________________________________________________________

(in block letters)

Signature: _____________________________

Date: |__|__|__|__| |__|__| |__|__|

Y Y Y Y M M D D

Time: |__|__h|__|__|

2012/12/20 Subject initials