<br>        Inclusion Criteria:<br><br>          -  Male and female subjects, 18-65 years of age, inclusive, at the time of signature of<br>             informed consent<br><br>          -  Documented AGHD i.e. childhood onset (CO) or adult onset (AO), either by a stimulation<br>             test as described in the GH Research Society's 2007 guidelines for the diagnosis and<br>             treatment of AGHD, or in the Saizen® label, whichever is more stringent, or by<br>             confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-1<br>             level below the reference range of the laboratory where testing is performed.<br>             Stimulation test as described in the 2007 GH Research Society guidelines and<br>             applicable to all subjects who underwent or will undergo a stimulation test:<br><br>               -  Insulin Tolerance Test (ITT) or glucagon stimulation test: Peak GH less than 3<br>                  nanogram per milliliter (ng/mL);<br><br>               -  GH-releasing hormone (GHRH) plus arginine test, peak GH depends on body mass<br>                  index (BMI):<br><br>                    -  BMI less than 25 kilogram per square meter (kg/m^2) indicates a peak GH less<br>                       than 11 ng/mL microgram per liter [mcg/L]).<br><br>                    -  BMI 25-30 kg/m^2 indicates a peak GH less than 8 ng/mL (mcgg/L).<br><br>                    -  BMI greater than 30 kg/m^2 indicates a peak GH less than 4 ng/mL (mcg/L).<br><br>        Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for<br>        determining eligibility in this trial. Stimulation tests remain under the Investigator's or<br>        the subject's physician's responsibility, including the selection of the GH assay. Saizen®<br>        label: in Europe, only one single test is required; in Australia, 2 stimulation tests<br>        showing a peak GH less than 2.5 ng/mL are required. The inclusion criteria were chosen<br>        based on the approved label for Saizen® in the countries where the trial is being<br>        implemented, as well as in respect of the most current international guidelines for AGHD.<br>        There is no limit in time prior to the Screening visit for the stimulation test(s), as long<br>        as documentation is available and the stimulation tests comply with the GH Research Society<br>        2007 guidelines, and as such, there is no need to repeat the test for subjects having<br>        stopped their GH therapy prior to the Screening visit. No stimulation test is required for<br>        subjects with 3 or more pituitary hormone deficiencies<br><br>          -  GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to<br>             Screening visit. Whereas any prior use of GH is permitted, providing an adequate<br>             wash-out period is respected to secure the interpretation of the biomarkers, the<br>             reason for stopping the GH therapy should neither be safety- nor efficacy-related, and<br>             documentation should be present in the source information<br><br>          -  Negative BAbs from the Screening visit sample<br><br>          -  Body mass index (BMI, Weight in kilograms / Height in square meters) measured at<br>             Screening visit as less than or equal to 35 kilogram per square meter (kg/m^2)<br><br>          -  Negative serum pregnancy test at the Screening for women of childbearing potential and<br>             subject is not lactating<br><br>          -  Understanding and willingness of the subject to comply with the procedures of the<br>             study<br><br>          -  Informed Consent form signed prior to the performance of any trial-related activities<br><br>        Exclusion Criteria:<br><br>          -  Hypersensitivity to the active substance or to any of the Saizen® excipients<br><br>          -  Evidence of growing intracranial tumor including pituitary tumor, or affecting the<br>             optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior<br>             to and the 12 months after the Screening visit<br><br>          -  Presence of active malignancy, neoplasia or any evidence of progression or recurrence<br>             of an underlying tumor. In case of a history of neoplasia or any pre-existing<br>             malignancy, the tumor must be inactive and anti-tumor therapy completed prior to<br>             starting trial on active Saizen® therapy.<br><br>          -  Proliferative or pre-proliferative diabetic retinopathy<br><br>          -  Evidence of chronic underlying disease within 6 months prior to the Screening visit or<br>             concomitant medication that would interfere with subject compliance, the evaluation of<br>             trial results, or compromise the safety of the subject<br><br>          -  Severe hepatic or renal failure that could compromise the interpretation of IGF-1,<br>             that is: Alanine transaminase [ALT] or aspartate transaminase [AST] greater than 3 *<br>             upper limit of the normal range; Glomerular filtration rate (GFR) less than 30<br>             milliliter per minute (mL/min) Note: GFR will be calculated by the laboratory<br>             according to the Modification of Diet in Renal Disease (MDRD) equation<br><br>          -  History of anti-GH antibodies<br><br>          -  History or presence of an autoimmune disease, such as Hashimoto's disease or Systemic<br>             Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene<br>             defect<br><br>          -  Absence of effective contraception in place at the Screening visit in women of<br>             childbearing potential. Acceptable forms of effective contraception include:<br>             established use of oral (greater than 2 months), injected, or implanted hormonal<br>             methods of contraception, intrauterine devices (IUD), or barrier methods of<br>             contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault<br>             caps) with spermicidal foam/gel/film/cream/suppository<br><br>          -  Diabetes mellitus (per American Diabetes Association 2010 guidelines): either i)<br>             standard diabetes symptoms and a random glucose greater than or equal to 200 milligram<br>             per deciliter (mg/dL) (11.1 millimolar per liter [mmol/L]); ii) a fasting plasma<br>             glucose greater than 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose greater<br>             than or equal to 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);<br>             or iv) an glycosylated hemoglobin (HbA1c) greater than or equal to 6.5 percent<br><br>          -  Concomitant or prior participation in an interventional trial within 30 days prior to<br>             the Screening visit<br><br>          -  Known alcohol or drug addiction/dependency<br><br>          -  Has a legal incapacity or limited legal capacity<br><br>          -  Has received anabolic steroids (except for gonadal steroid replacement therapy) or<br>             systemic corticosteroids (except for replacement doses) within 3 months prior to the<br>             Screening visit<br><br>          -  Has received substitutive therapy with glucocorticosteroids, thyroid replacement,<br>             vasopressin, or sex hormones for less than 3 months or substitutive therapy has not<br>             been stable (that is, dose was not generally constant or medical condition was not<br>             controlled) for 3 months prior to Screening<br>      ;<br>        Inclusion Criteria:<br><br>          -  Male and female subjects, 18-65 years of age, inclusive, at the time of signature of<br>             informed consent<br><br>          -  Documented AGHD i.e. childhood onset (CO) or adult onset (AO), either by a stimulation<br>             test as described in the GH Research Society's 2007 guidelines for the diagnosis and<br>             treatment of AGHD, or in the Saizen® label, whichever is more stringent, or by<br>             confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-1<br>             level below the reference range of the laboratory where testing is performed.<br>             Stimulation test as described in the 2007 GH Research Society guidelines and<br>             applicable to all subjects who underwent or will undergo a stimulation test:<br><br>               -  Insulin Tolerance Test (ITT) or glucagon stimulation test: Peak GH less than 3<br>                  nanogram per milliliter (ng/mL);<br><br>               -  GH-releasing hormone (GHRH) plus arginine test, peak GH depends on body mass<br>                  index (BMI):<br><br>                    -  BMI less than 25 kilogram per square meter (kg/m^2) indicates a peak GH less<br>                       than 11 ng/mL microgram per liter [mcg/L]).<br><br>                    -  BMI 25-30 kg/m^2 indicates a peak GH less than 8 ng/mL (mcgg/L).<br><br>                    -  BMI greater than 30 kg/m^2 indicates a peak GH less than 4 ng/mL (mcg/L).<br><br>        Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for<br>        determining eligibility in this trial. Stimulation tests remain under the Investigator's or<br>        the subject's physician's responsibility, including the selection of the GH assay. Saizen®<br>        label: in Europe, only one single test is required; in Australia, 2 stimulation tests<br>        showing a peak GH less than 2.5 ng/mL are required. The inclusion criteria were chosen<br>        based on the approved label for Saizen® in the countries where the trial is being<br>        implemented, as well as in respect of the most current international guidelines for AGHD.<br>        There is no limit in time prior to the Screening visit for the stimulation test(s), as long<br>        as documentation is available and the stimulation tests comply with the GH Research Society<br>        2007 guidelines, and as such, there is no need to repeat the test for subjects having<br>        stopped their GH therapy prior to the Screening visit. No stimulation test is required for<br>        subjects with 3 or more pituitary hormone deficiencies<br><br>          -  GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to<br>             Screening visit. Whereas any prior use of GH is permitted, providing an adequate<br>             wash-out period is respected to secure the interpretation of the biomarkers, the<br>             reason for stopping the GH therapy should neither be safety- nor efficacy-related, and<br>             documentation should be present in the source information<br><br>          -  Negative BAbs from the Screening visit sample<br><br>          -  Body mass index (BMI, Weight in kilograms / Height in square meters) measured at<br>             Screening visit as less than or equal to 35 kilogram per square meter (kg/m^2)<br><br>          -  Negative serum pregnancy test at the Screening for women of childbearing potential and<br>             subject is not lactating<br><br>          -  Understanding and willingness of the subject to comply with the procedures of the<br>             study<br><br>          -  Informed Consent form signed prior to the performance of any trial-related activities<br><br>        Exclusion Criteria:<br><br>          -  Hypersensitivity to the active substance or to any of the Saizen® excipients<br><br>          -  Evidence of growing intracranial tumor including pituitary tumor, or affecting the<br>             optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior<br>             to and the 12 months after the Screening visit<br><br>          -  Presence of active malignancy, neoplasia or any evidence of progression or recurrence<br>             of an underlying tumor. In case of a history of neoplasia or any pre-existing<br>             malignancy, the tumor must be inactive and anti-tumor therapy completed prior to<br>             starting trial on active Saizen® therapy.<br><br>          -  Proliferative or pre-proliferative diabetic retinopathy<br><br>          -  Evidence of chronic underlying disease within 6 months prior to the Screening visit or<br>             concomitant medication that would interfere with subject compliance, the evaluation of<br>             trial results, or compromise the safety of the subject<br><br>          -  Severe hepatic or renal failure that could compromise the interpretation of IGF-1,<br>             that is: Alanine transaminase [ALT] or aspartate transaminase [AST] greater than 3 *<br>             upper limit of the normal range; Glomerular filtration rate (GFR) less than 30<br>             milliliter per minute (mL/min) Note: GFR will be calculated by the laboratory<br>             according to the Modification of Diet in Renal Disease (MDRD) equation<br><br>          -  History of anti-GH antibodies<br><br>          -  History or presence of an autoimmune disease, such as Hashimoto's disease or Systemic<br>             Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene<br>             defect<br><br>          -  Absence of effective contraception in place at the Screening visit in women of<br>             childbearing potential. Acceptable forms of effective contraception include:<br>             established use of oral (greater than 2 months), injected, or implanted hormonal<br>             methods of contraception, intrauterine devices (IUD), or barrier methods of<br>             contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault<br>             caps) with spermicidal foam/gel/film/cream/suppository<br><br>          -  Diabetes mellitus (per American Diabetes Association 2010 guidelines): either i)<br>             standard diabetes symptoms and a random glucose greater than or equal to 200 milligram<br>             per deciliter (mg/dL) (11.1 millimolar per liter [mmol/L]); ii) a fasting plasma<br>             glucose greater than 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose greater<br>             than or equal to 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);<br>             or iv) an glycosylated hemoglobin (HbA1c) greater than or equal to 6.5 percent<br><br>          -  Concomitant or prior participation in an interventional trial within 30 days prior to<br>             the Screening visit<br><br>          -  Known alcohol or drug addiction/dependency<br><br>          -  Has a legal incapacity or limited legal capacity<br><br>          -  Has received anabolic steroids (except for gonadal steroid replacement therapy) or<br>             systemic corticosteroids (except for replacement doses) within 3 months prior to the<br>             Screening visit<br><br>          -  Has received substitutive therapy with glucocorticosteroids, thyroid replacement,<br>             vasopressin, or sex hormones for less than 3 months or substitutive therapy has not<br>             been stable (that is, dose was not generally constant or medical condition was not<br>             controlled) for 3 months prior to Screening<br>      ;<br>        Inclusion Criteria:<br><br>          -  Male and female subjects, 18-65 years of age, inclusive, at the time of signature of<br>             informed consent<br><br>          -  Documented AGHD i.e. childhood onset (CO) or adult onset (AO), either by a stimulation<br>             test as described in the GH Research Society's 2007 guidelines for the diagnosis and<br>             treatment of AGHD, or in the Saizen® label, whichever is more stringent, or by<br>             confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-1<br>             level below the reference range of the laboratory where testing is performed.<br>             Stimulation test as described in the 2007 GH Research Society guidelines and<br>             applicable to all subjects who underwent or will undergo a stimulation test:<br><br>               -  Insulin Tolerance Test (ITT) or glucagon stimulation test: Peak GH less than 3<br>                  nanogram per milliliter (ng/mL);<br><br>               -  GH-releasing hormone (GHRH) plus arginine test, peak GH depends on body mass<br>                  index (BMI):<br><br>                    -  BMI less than 25 kilogram per square meter (kg/m^2) indicates a peak GH less<br>                       than 11 ng/mL microgram per liter [mcg/L]).<br><br>                    -  BMI 25-30 kg/m^2 indicates a peak GH less than 8 ng/mL (mcgg/L).<br><br>                    -  BMI greater than 30 kg/m^2 indicates a peak GH less than 4 ng/mL (mcg/L).<br><br>        Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for<br>        determining eligibility in this trial. Stimulation tests remain under the Investigator's or<br>        the subject's physician's responsibility, including the selection of the GH assay. Saizen®<br>        label: in Europe, only one single test is required; in Australia, 2 stimulation tests<br>        showing a peak GH less than 2.5 ng/mL are required. The inclusion criteria were chosen<br>        based on the approved label for Saizen® in the countries where the trial is being<br>        implemented, as well as in respect of the most current international guidelines for AGHD.<br>        There is no limit in time prior to the Screening visit for the stimulation test(s), as long<br>        as documentation is available and the stimulation tests comply with the GH Research Society<br>        2007 guidelines, and as such, there is no need to repeat the test for subjects having<br>        stopped their GH therapy prior to the Screening visit. No stimulation test is required for<br>        subjects with 3 or more pituitary hormone deficiencies<br><br>          -  GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to<br>             Screening visit. Whereas any prior use of GH is permitted, providing an adequate<br>             wash-out period is respected to secure the interpretation of the biomarkers, the<br>             reason for stopping the GH therapy should neither be safety- nor efficacy-related, and<br>             documentation should be present in the source information<br><br>          -  Negative BAbs from the Screening visit sample<br><br>          -  Body mass index (BMI, Weight in kilograms / Height in square meters) measured at<br>             Screening visit as less than or equal to 35 kilogram per square meter (kg/m^2)<br><br>          -  Negative serum pregnancy test at the Screening for women of childbearing potential and<br>             subject is not lactating<br><br>          -  Understanding and willingness of the subject to comply with the procedures of the<br>             study<br><br>          -  Informed Consent form signed prior to the performance of any trial-related activities<br><br>        Exclusion Criteria:<br><br>          -  Hypersensitivity to the active substance or to any of the Saizen® excipients<br><br>          -  Evidence of growing intracranial tumor including pituitary tumor, or affecting the<br>             optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior<br>             to and the 12 months after the Screening visit<br><br>          -  Presence of active malignancy, neoplasia or any evidence of progression or recurrence<br>             of an underlying tumor. In case of a history of neoplasia or any pre-existing<br>             malignancy, the tumor must be inactive and anti-tumor therapy completed prior to<br>             starting trial on active Saizen® therapy.<br><br>          -  Proliferative or pre-proliferative diabetic retinopathy<br><br>          -  Evidence of chronic underlying disease within 6 months prior to the Screening visit or<br>             concomitant medication that would interfere with subject compliance, the evaluation of<br>             trial results, or compromise the safety of the subject<br><br>          -  Severe hepatic or renal failure that could compromise the interpretation of IGF-1,<br>             that is: Alanine transaminase [ALT] or aspartate transaminase [AST] greater than 3 *<br>             upper limit of the normal range; Glomerular filtration rate (GFR) less than 30<br>             milliliter per minute (mL/min) Note: GFR will be calculated by the laboratory<br>             according to the Modification of Diet in Renal Disease (MDRD) equation<br><br>          -  History of anti-GH antibodies<br><br>          -  History or presence of an autoimmune disease, such as Hashimoto's disease or Systemic<br>             Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene<br>             defect<br><br>          -  Absence of effective contraception in place at the Screening visit in women of<br>             childbearing potential. Acceptable forms of effective contraception include:<br>             established use of oral (greater than 2 months), injected, or implanted hormonal<br>             methods of contraception, intrauterine devices (IUD), or barrier methods of<br>             contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault<br>             caps) with spermicidal foam/gel/film/cream/suppository<br><br>          -  Diabetes mellitus (per American Diabetes Association 2010 guidelines): either i)<br>             standard diabetes symptoms and a random glucose greater than or equal to 200 milligram<br>             per deciliter (mg/dL) (11.1 millimolar per liter [mmol/L]); ii) a fasting plasma<br>             glucose greater than 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose greater<br>             than or equal to 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);<br>             or iv) an glycosylated hemoglobin (HbA1c) greater than or equal to 6.5 percent<br><br>          -  Concomitant or prior participation in an interventional trial within 30 days prior to<br>             the Screening visit<br><br>          -  Known alcohol or drug addiction/dependency<br><br>          -  Has a legal incapacity or limited legal capacity<br><br>          -  Has received anabolic steroids (except for gonadal steroid replacement therapy) or<br>             systemic corticosteroids (except for replacement doses) within 3 months prior to the<br>             Screening visit<br><br>          -  Has received substitutive therapy with glucocorticosteroids, thyroid replacement,<br>             vasopressin, or sex hormones for less than 3 months or substitutive therapy has not<br>             been stable (that is, dose was not generally constant or medical condition was not<br>             controlled) for 3 months prior to Screening<br>      ;<br>        Inclusion Criteria:<br><br>          -  Male and female subjects, 18-65 years of age, inclusive, at the time of signature of<br>             informed consent<br><br>          -  Documented AGHD i.e. childhood onset (CO) or adult onset (AO), either by a stimulation<br>             test as described in the GH Research Society's 2007 guidelines for the diagnosis and<br>             treatment of AGHD, or in the Saizen® label, whichever is more stringent, or by<br>             confirming the presence of at least 3 pituitary hormone deficiencies and an IGF-1<br>             level below the reference range of the laboratory where testing is performed.<br>             Stimulation test as described in the 2007 GH Research Society guidelines and<br>             applicable to all subjects who underwent or will undergo a stimulation test:<br><br>               -  Insulin Tolerance Test (ITT) or glucagon stimulation test: Peak GH less than 3<br>                  nanogram per milliliter (ng/mL);<br><br>               -  GH-releasing hormone (GHRH) plus arginine test, peak GH depends on body mass<br>                  index (BMI):<br><br>                    -  BMI less than 25 kilogram per square meter (kg/m^2) indicates a peak GH less<br>                       than 11 ng/mL microgram per liter [mcg/L]).<br><br>                    -  BMI 25-30 kg/m^2 indicates a peak GH less than 8 ng/mL (mcgg/L).<br><br>                    -  BMI greater than 30 kg/m^2 indicates a peak GH less than 4 ng/mL (mcg/L).<br><br>        Clonidine, l-dopa, and arginine alone are not acceptable as stimulation tests for<br>        determining eligibility in this trial. Stimulation tests remain under the Investigator's or<br>        the subject's physician's responsibility, including the selection of the GH assay. Saizen®<br>        label: in Europe, only one single test is required; in Australia, 2 stimulation tests<br>        showing a peak GH less than 2.5 ng/mL are required. The inclusion criteria were chosen<br>        based on the approved label for Saizen® in the countries where the trial is being<br>        implemented, as well as in respect of the most current international guidelines for AGHD.<br>        There is no limit in time prior to the Screening visit for the stimulation test(s), as long<br>        as documentation is available and the stimulation tests comply with the GH Research Society<br>        2007 guidelines, and as such, there is no need to repeat the test for subjects having<br>        stopped their GH therapy prior to the Screening visit. No stimulation test is required for<br>        subjects with 3 or more pituitary hormone deficiencies<br><br>          -  GH treatment-naïve or prior GH treatment for AGHD stopped at least 1 month prior to<br>             Screening visit. Whereas any prior use of GH is permitted, providing an adequate<br>             wash-out period is respected to secure the interpretation of the biomarkers, the<br>             reason for stopping the GH therapy should neither be safety- nor efficacy-related, and<br>             documentation should be present in the source information<br><br>          -  Negative BAbs from the Screening visit sample<br><br>          -  Body mass index (BMI, Weight in kilograms / Height in square meters) measured at<br>             Screening visit as less than or equal to 35 kilogram per square meter (kg/m^2)<br><br>          -  Negative serum pregnancy test at the Screening for women of childbearing potential and<br>             subject is not lactating<br><br>          -  Understanding and willingness of the subject to comply with the procedures of the<br>             study<br><br>          -  Informed Consent form signed prior to the performance of any trial-related activities<br><br>        Exclusion Criteria:<br><br>          -  Hypersensitivity to the active substance or to any of the Saizen® excipients<br><br>          -  Evidence of growing intracranial tumor including pituitary tumor, or affecting the<br>             optic chiasm, or requiring treatment (surgery or radiation) within the 6 months prior<br>             to and the 12 months after the Screening visit<br><br>          -  Presence of active malignancy, neoplasia or any evidence of progression or recurrence<br>             of an underlying tumor. In case of a history of neoplasia or any pre-existing<br>             malignancy, the tumor must be inactive and anti-tumor therapy completed prior to<br>             starting trial on active Saizen® therapy.<br><br>          -  Proliferative or pre-proliferative diabetic retinopathy<br><br>          -  Evidence of chronic underlying disease within 6 months prior to the Screening visit or<br>             concomitant medication that would interfere with subject compliance, the evaluation of<br>             trial results, or compromise the safety of the subject<br><br>          -  Severe hepatic or renal failure that could compromise the interpretation of IGF-1,<br>             that is: Alanine transaminase [ALT] or aspartate transaminase [AST] greater than 3 *<br>             upper limit of the normal range; Glomerular filtration rate (GFR) less than 30<br>             milliliter per minute (mL/min) Note: GFR will be calculated by the laboratory<br>             according to the Modification of Diet in Renal Disease (MDRD) equation<br><br>          -  History of anti-GH antibodies<br><br>          -  History or presence of an autoimmune disease, such as Hashimoto's disease or Systemic<br>             Lupus Erythematosus (SLE), immunosuppression regardless of etiology, or GH1 gene<br>             defect<br><br>          -  Absence of effective contraception in place at the Screening visit in women of<br>             childbearing potential. Acceptable forms of effective contraception include:<br>             established use of oral (greater than 2 months), injected, or implanted hormonal<br>             methods of contraception, intrauterine devices (IUD), or barrier methods of<br>             contraception, specifically, condom or occlusive cap (diaphragm or cervical/vault<br>             caps) with spermicidal foam/gel/film/cream/suppository<br><br>          -  Diabetes mellitus (per American Diabetes Association 2010 guidelines): either i)<br>             standard diabetes symptoms and a random glucose greater than or equal to 200 milligram<br>             per deciliter (mg/dL) (11.1 millimolar per liter [mmol/L]); ii) a fasting plasma<br>             glucose greater than 126 mg/dL (6.99 mmol/L); iii) a 2-hour plasma glucose greater<br>             than or equal to 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test (OGTT);<br>             or iv) an glycosylated hemoglobin (HbA1c) greater than or equal to 6.5 percent<br><br>          -  Concomitant or prior participation in an interventional trial within 30 days prior to<br>             the Screening visit<br><br>          -  Known alcohol or drug addiction/dependency<br><br>          -  Has a legal incapacity or limited legal capacity<br><br>          -  Has received anabolic steroids (except for gonadal steroid replacement therapy) or<br>             systemic corticosteroids (except for replacement doses) within 3 months prior to the<br>             Screening visit<br><br>          -  Has received substitutive therapy with glucocorticosteroids, thyroid replacement,<br>             vasopressin, or sex hormones for less than 3 months or substitutive therapy has not<br>             been stable (that is, dose was not generally constant or medical condition was not<br>             controlled) for 3 months prior to Screening<br>