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| Name | Class |
|---|---|
| Laboratory Corporation of America | INDUSTRY |
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This study evaluates anastrazole and clomiphene in the improvement in hypogonadal symptoms and erectile function. Each subject will receive Anastrazole 1 mg/day, clomiphene 25 mg/day and placebo in randomized schedule of 8 week intervals.
Aromatase inhibitors (AI) (Anastrazole) and selective estrogen receptor modifiers (SERMS)(clomiphene) increase testosterone production through stimulation of the hypothalamic pituitary axis. While these drugs both reduce the feedback inhibition of estrogen on the pituitary, SERMs cause an increase in serum estradiol, whereas AIs reduce estradiol levels. Using these medications, we can obtain therapeutic testosterone levels with either an increase or decrease in estradiol levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anastrazole-clomiphene-placebo | Other | anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks |
|
| anastrazole-placebo-clomiphene | Other | anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks |
|
| clomiphene-anastrazole-placebo | Other | clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks |
|
| clomiphene-placebo-anastrazole | Other | clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks |
|
| placebo-clomiphene-anastrazole | Other | placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole 1mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| IIEF (International Index of Erectile Function) Score - Screen | 15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 | At baseline |
| IIEF (International Index of Erectile Function) Score - Week 8 | 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 | Week 8 |
| IIEF (International Index of Erectile Function) Score - Week 16 | 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 | Week 16 |
| IIEF (International Index of Erectile Function) Score - Week 24 | 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Normalized Testosterone - Screen | Normalized at >350ng/dl | Baseline |
| Normalized Testosterone - Week 8 | Normalized at >350ng/dl | Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert C Welliver, MD | Albany Medical College | Principal Investigator |
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Men will be incentivized to come to each clinic appointment with $20 dollars at the end. If they complete the study they will be able to earn $100. Men will be incentivized to not use phosphodiesterase inhibitors throughout the study by giving them three 100mg tablets of Viagra per month of the study for a total of twelve 100 mg tablets.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anastrazole-clomiphene-placebo | anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| FG001 | Anastrazole-placebo-clomiphene | anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| FG002 | Clomiphene-anastrazole-placebo | clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| FG003 | Clomiphene-placebo-anastrazole | clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| FG004 | Placebo-clomiphene-anastrazole | placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| FG005 | Placebo-anastrazole-clomiphene | placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| Baseline to Week 8 |
| |||||||||||||
| Week 8 to Week 16 |
| |||||||||||||
| Week 16 to Week 24 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anastrazole-clomiphene-placebo | anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| BG001 | Anastrazole-placebo-clomiphene |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IIEF (International Index of Erectile Function) Score - Screen | 15 item self reported erectile function. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 | Total IIEF reported at the initial encounter. | Posted | Number | score on a scale | At baseline |
|
Adverse events were collected after the first dose of medication and at the end of week 8, week 16, and week 24 at a participant and provider meeting.
The 6 arms are comprised of certain orders of drug administration. To maintain the integrity of this order, AE have been listed as part of the arm it belongs to. Details regarding when the AE occurred in relation to the drug being administered at that point in time during the arm is listed at the bottom of the table.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anastrazole-clomiphene-placebo | anastrozole for eight weeks then clomiphene for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lyme Disease | Infections and infestations | Systematic Assessment | AE occured during placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment | AE occured during anastrazole in both trial arms indicated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Welliver | Albany Medical Center | 518-262-3341 | wellivr@amc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2015 | Jul 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005058 | Eunuchism |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| placebo-anastrazole-clomiphene | Other | placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks |
|
| Clomiphene Citrate 25mg | Drug |
|
| Placebo - Cap | Drug |
|
| Normalized Testosterone - Week 16 | Normalized at >350ng/dl | Week 16 |
| Normalized Testosterone - Week 24 | Normalized at >350ng/dl | Week 24 |
| ADAM (Androgen Deficiency in the Aging Male) Score - Screen | Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0 | Baseline |
| ADAM (Androgen Deficiency in the Aging Male) Score - Week 8 | Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0 | Week 8 |
| ADAM (Androgen Deficiency in the Aging Male) Score - Week 16 | Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0 | Week 16 |
| ADAM (Androgen Deficiency in the Aging Male) Score - Week 24 | Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0 | Week 24 |
| EHS (Erectile Hardness Score) - Screen | Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid | Baseline |
| EHS (Erectile Hardness Score) - Week 8 | Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid | Week 8 |
| EHS (Erectile Hardness Score) - Week 16 | Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid | Week 16 |
| EHS (Erectile Hardness Score) - Week 24 | Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid | Week 24 |
| LH - Screen | Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. | Baseline |
| LH - Week 8 | Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. | Week 8 |
| LH - Week 16 | Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. | Week 16 |
| LH - Week 24 | Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. | Week 24 |
| FSH - Screen | Lab Values for follicle stimulating hormone | Baseline |
| FSH - Week 8 | Lab Values for follicle stimulating hormone | Week 8 |
| FSH - Week 16 | Lab Values for follicle stimulating hormone | Week 16 |
| FSH - Week 24 | Lab Values for follicle stimulating hormone | Week 24 |
| Free Testosterone - Screen | Measure of Free Testosterone | Baseline |
| Free Testosterone - Week 8 | Measure of Free Testosterone | Week 8 |
| Free Testosterone - Week 16 | Measure of Free Testosterone | Week 16 |
| Free Testosterone - Week 24 | Measure of Free Testosterone | Week 24 |
| Estradiol - Screen | Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 | Baseline |
| Estradiol - Week 8 | Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 | Week 8 |
| Estradiol - Week 16 | Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 | Week 16 |
| Estradiol - Week 24 | Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 | Week 24 |
| SHBG - Screen | Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 | Baseline |
| SHBG - Week 8 | Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 | Week 8 |
| SHBG - Week 16 | Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 | Week 16 |
| SHBG - Week 24 | Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 | Week 24 |
| SEP #1-3 Cumulative - Screen | Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0 | Baseline |
| SEP #1-3 Cumulative - Week 8 | Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0 | Week 8 |
| SEP #1-3 Cumulative - Week 16 | Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0 | Week 16 |
| SEP #1-3 Cumulative - Week 24 | Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0 | Week 24 |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks
Anastrozole 1mg
Clomiphene Citrate 25mg
Placebo - Cap
| BG002 | Clomiphene-anastrazole-placebo | clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| BG003 | Clomiphene-placebo-anastrazole | clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| BG004 | Placebo-clomiphene-anastrazole | placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| BG005 | Placebo-anastrazole-clomiphene | placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Clomiphene-anastrazole-placebo | clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| OG003 | Clomiphene-placebo-anastrazole | clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| OG004 | Placebo-clomiphene-anastrazole | placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
| OG005 | Placebo-anastrazole-clomiphene | placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap |
|
|
| Primary | IIEF (International Index of Erectile Function) Score - Week 8 | 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 | Total IIEF reported at the end of the first 8 week period | Posted | Number | score on a scale | Week 8 |
|
|
|
| Primary | IIEF (International Index of Erectile Function) Score - Week 16 | 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 | Total IIEF reported at the end of the second 8 week period - at week 16 Data for patient 23 was not collected in the placebo-clomiphene-anastrazole arm. | Posted | Number | score on a scale | Week 16 |
|
|
|
| Primary | IIEF (International Index of Erectile Function) Score - Week 24 | 15 item self reported erectile function over the past 8 weeks. Each item is scored 0-5 with 0=negative response and 5 = positive response with totals of 0-75 | Total IIEF reported at the end of the final 8 week period - at week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole | Posted | Number | score on a scale | Week 24 |
|
|
|
| Secondary | Normalized Testosterone - Screen | Normalized at >350ng/dl | Normalized Testosterone measured week 0 - initial screen Data not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | ng/dl | Baseline |
|
|
|
| Secondary | Normalized Testosterone - Week 8 | Normalized at >350ng/dl | Normalized Testosterone measured at the end of the first 8 week period Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm | Posted | Number | ng/dl | Week 8 |
|
|
|
| Secondary | Normalized Testosterone - Week 16 | Normalized at >350ng/dl | Normalized Testosterone measured at the end of the 16th week Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm | Posted | Number | ng/dl | Week 16 |
|
|
|
| Secondary | Normalized Testosterone - Week 24 | Normalized at >350ng/dl | Normalized Testosterone measured at the end of the 24th week Data was not collected for patient 15 clomiphene-anastrazole-placebo Data for patient 23 was not collected for placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene | Posted | Number | ng/dl | Week 24 |
|
|
|
| Secondary | ADAM (Androgen Deficiency in the Aging Male) Score - Screen | Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0 | Initial Evaluation for ADAM score - Week 0 | Posted | Number | score on a scale | Baseline |
|
|
|
| Secondary | ADAM (Androgen Deficiency in the Aging Male) Score - Week 8 | Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0 | ADAM score at the end of Week 8 Data was not collected for patient 19 in anastrazole-clomiphene-placebo arm | Posted | Number | score on a scale | Week 8 |
|
|
|
| Secondary | ADAM (Androgen Deficiency in the Aging Male) Score - Week 16 | Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0 | ADAM score at the end of Week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | score on a scale | Week 16 |
|
|
|
| Secondary | ADAM (Androgen Deficiency in the Aging Male) Score - Week 24 | Self reported quantification of hypogonadism. 10 "yes" or "no" questions. A positive (yes) questionnaire result is defined as a "yes or 1" and a negative (no) questionnaire result is defined as a "no or 0" to question 1 or question 7 or any 3 other questions. Yes (1) represents a better outcome than No (1) In Data Entry: Yes - 1 No - 0 | ADAM score at the end of Week 24 No data collected pt 15 in clomiphene-anastrazole-placebo arm no data collected for pt 16 clomiphene-placebo-anastrazole arm no data collected for pt 23 placebo-clomiphene-anastrazole arm | Posted | Number | score on a scale | Week 24 |
|
|
|
| Secondary | EHS (Erectile Hardness Score) - Screen | Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid | Score 0-4 at the initial encounter week 0 | Posted | Number | score on a scale | Baseline |
|
|
|
| Secondary | EHS (Erectile Hardness Score) - Week 8 | Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid | Score 0-4 at the end of Week 8 | Posted | Number | score on a scale | Week 8 |
|
|
|
| Secondary | EHS (Erectile Hardness Score) - Week 16 | Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid | Score 0-4 at the end of Week 16 Data for patient 23 was not collected in placebo-clomiphene-anastrazole arm | Posted | Number | score on a scale | Week 16 |
|
|
|
| Secondary | EHS (Erectile Hardness Score) - Week 24 | Self reported questionnaire rated 0-4 0=penis does not enlarge, 4=Penis completely hard and fully rigid | Score 0-4 at the end of Week 24 no data was collected for patient 15 in clomiphene-anastrazole-placebo no data was collected for patient 23 in placebo-clomiphene-anastrazole | Posted | Number | score on a scale | Week 24 |
|
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|
| Secondary | LH - Screen | Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. | LH measured at initial encounter Data for pt 23 in placebo-clomiphene-anastrazole not collected | Posted | Number | IU/L | Baseline |
|
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| Secondary | LH - Week 8 | Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. | LH measured at week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | IU/L | Week 8 |
|
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| Secondary | LH - Week 16 | Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. | LH measured at week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | IU/L | Week 16 |
|
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| Secondary | LH - Week 24 | Luteinizing Hormone levels collected at the initial encounter and at the end of the 8, 16, and 24 week periods. | LH measured at week 24 No data for patient 13 collected in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm | Posted | Number | IU/L | Week 24 |
|
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| Secondary | FSH - Screen | Lab Values for follicle stimulating hormone | FSH measured at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | IU/L | Baseline |
|
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| Secondary | FSH - Week 8 | Lab Values for follicle stimulating hormone | FSH measured at Week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | IU/L | Week 8 |
|
|
|
| Secondary | FSH - Week 16 | Lab Values for follicle stimulating hormone | FSH measured at Week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | IU/L | Week 16 |
|
|
|
| Secondary | FSH - Week 24 | Lab Values for follicle stimulating hormone | FSH measured at Week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm | Posted | Number | IU/L | Week 24 |
|
|
|
| Secondary | Free Testosterone - Screen | Measure of Free Testosterone | FT measured at initial encounter Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | ng/dl | Baseline |
|
|
|
| Secondary | Free Testosterone - Week 8 | Measure of Free Testosterone | FT measured at the end of Week 8 Data was not collected for patient 8 in anastrazole-placebo-clomiphene arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | ng/dl | Week 8 |
|
|
|
| Secondary | Free Testosterone - Week 16 | Measure of Free Testosterone | FT measured at the end of Week 16 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 22 in clomiphene-placebo-anastrazole arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | ng/dl | Week 16 |
|
|
|
| Secondary | Free Testosterone - Week 24 | Measure of Free Testosterone | FT measured at the end of Week 24 Data not collected for patient 8 in APC arm Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 18 in placebo-anastrazole-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm No data collected pt 24 in PAC arm | Posted | Number | ng/dl | Week 24 |
|
|
|
| Secondary | Estradiol - Screen | Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 | Estradiol measurement at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | pg/mL | Baseline |
|
|
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| Secondary | Estradiol - Week 8 | Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 | Estradiol measurement at the end of Week 8 Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | pg/mL | Week 8 |
|
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| Secondary | Estradiol - Week 16 | Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 | Estradiol measurement at the end of Week 16 Data was not collected for patient 2 in anastrazole-placebo-clomiphene arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | pg/mL | Week 16 |
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| Secondary | Estradiol - Week 24 | Measurement of Estradiol levels at initial encounter and at the end of Weeks 8, 16, and 24 An entered value of 4.9 means the measure was <5 | Estradiol measurement at the end of Week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm | Posted | Number | pg/mL | Week 24 |
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| Secondary | SHBG - Screen | Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 | SHBG measured at initial encounter Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | nmol/L | Baseline |
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| Secondary | SHBG - Week 8 | Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 | SHBG measured at week 8 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | nmol/L | Week 8 |
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| Secondary | SHBG - Week 16 | Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 | SHBG measured at week 16 Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm | Posted | Number | nmol/L | Week 16 |
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| Secondary | SHBG - Week 24 | Lab Measure of sex hormone binding globulin at the initial encounter and at the ends of week 8, 16, and 24 | SHBG measured at week 24 Data was not collected for patient 15 in clomiphene-anastrazole-placebo arm Data was not collected for patient 23 in placebo-clomiphene-anastrazole arm Data was not collected for patient 24 in placebo-anastrazole-clomiphene arm | Posted | Number | nmol/L | Week 24 |
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| Secondary | SEP #1-3 Cumulative - Screen | Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0 | SEP measured at the initial encounter Baseline SPEP was not measured for participants 1-24 Table included for completeness | Posted | Baseline |
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| Secondary | SEP #1-3 Cumulative - Week 8 | Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0 | SEP measured at the end of week 8 data not collected for pt 11,17 in PCA arm data not collected for pt 13 in ACP arm data not collected for pt 15 in CAP arm data not collected for pt 22 in CPA arm | Posted | Number | score on a scale | Week 8 |
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| Secondary | SEP #1-3 Cumulative - Week 16 | Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0 | SEP measured at the end of week 16 data not collected for pt 3,15 in CAP arm data not collected for pt 5,11,23 in PCA arm | Posted | Number | score on a scale | Week 16 |
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| Secondary | SEP #1-3 Cumulative - Week 24 | Questions 1, 2, and 3 for the Sexual Encounter Profile have been cumulatively added. 1 - yes and 0 - no have been added for questions 1-3 to determine a total value from 0-3. 0-3: cumulative score from SEP questions 1, 2, and 3 Higher values (3) are considered to be a better outcomes relative to lower numbers (0) 3 is better than 2 is better than 1 is better than 0 | SEP measured at the end of week 24 data not collected for pt 1,13 in ACP arm data not collected for pt 3, 15 in CAP arm data not collected for pt 22 in CPA arm data not collected for pt 11,23 PCA arm | Posted | Number | score on a scale | Week 24 |
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|
| 0 |
| 4 |
| 0 |
| 4 |
| 2 |
| 4 |
| EG001 | Anastrazole-placebo-clomiphene | anastrozole for eight weeks then placebo for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap | 0 | 4 | 0 | 4 | 1 | 4 |
| EG002 | Clomiphene-anastrazole-placebo | clomiphene for eight weeks then anastrozole for eight weeks then placebo for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap | 0 | 4 | 0 | 4 | 1 | 4 |
| EG003 | Clomiphene-placebo-anastrazole | clomiphene for eight weeks then placebo for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap | 0 | 4 | 0 | 4 | 1 | 4 |
| EG004 | Placebo-clomiphene-anastrazole | placebo for eight weeks then clomiphene for eight weeks then anastrozole for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap | 0 | 4 | 1 | 4 | 1 | 4 |
| EG005 | Placebo-anastrazole-clomiphene | placebo for eight weeks then anastrozole for eight weeks then clomiphene for eight weeks Anastrozole 1mg Clomiphene Citrate 25mg Placebo - Cap | 0 | 4 | 0 | 4 | 3 | 4 |
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| Osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment | Osteopenia AE occurred during anastrazole. |
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| Rib Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | AE occured during anastrazole. |
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| Nasal Septal Deviation | General disorders | Systematic Assessment | Nasal Septal deviation AE occured during clomiphene. |
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| Left Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Left shoulder AE occured during placebo. |
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| Upper Respiratory Infection (URI) | Infections and infestations | Systematic Assessment | AE occured during placebo. |
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| Vitamin D deficiency | Endocrine disorders | Systematic Assessment | AE occured during placebo. |
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| Dizziness | Nervous system disorders | Systematic Assessment | AE occured during clomiphene |
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| Insomnia | General disorders | Systematic Assessment | AE occured during anastrazole in the trial arms indicated. |
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| Fatigue | General disorders | Systematic Assessment | AE occured during clomiphene of both trial arms indicated |
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| Weight Gain | Endocrine disorders | Systematic Assessment | AE occured during anastrazole |
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| Decreased Libido | Endocrine disorders | Systematic Assessment | AE occured during clomiphene |
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| Bloated | Gastrointestinal disorders | Systematic Assessment | AE occured during clomiphene |
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| Chronic Maxillary Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | AE occured during clomiphene |
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| Right Big Toe Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | AE occured during anastrazole |
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| Ringworm | Infections and infestations | Systematic Assessment | Ringworm AE occured during clomiphene. |
|
Not provided
Not provided
Not provided
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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| Patients 7-12 |
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| Patients 13-18 |
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| Patients 19-24 |
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