| Primary | Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C | Responders were participants with serum total testosterone average concentration (Cavg) between 300 and 1000 ng/dL derived from the 3rd injection intensive pharmacokinetic (IPK) interval. | Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
| | | Title | Denominators | Categories |
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| Primary | Serum Total Testosterone Average Concentration During the 3rd Injection Interval in Part C | Serum total testosterone Cavg derived from the 3rd injection IPK interval | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Mean | Standard Deviation | ng/dL | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Primary | Serum Total Testosterone Maximum Concentration During the 3rd Injection Interval in Part C | Serum total testosterone maximum concentration (Cmax) derived from the 3rd injection IPK interval | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Mean | Standard Deviation | ng/dL | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Primary | Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 3rd Injection in Part C | Serum total testosterone concentration at the end of the dosing interval (Ctrough) derived from the 3rd injection IPK interval | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Mean | Standard Deviation | ng/dL | | Day 70 post injection at week 14 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Primary | Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 4th Injection Interval in Part C | Responders were participants with serum total testosterone Cavg between 300 and 1000 ng/dL derived from the 4th injection IPK interval. | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Primary | Serum Total Testosterone Average Concentration During the 4th Injection Interval in Part C | Serum total testosterone Cavg derived from the 4th injection IPK interval | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Mean | Standard Deviation | ng/dL | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Primary | Serum Total Testosterone Maximum Concentration During the 4th Injection Interval in Part C | Serum total testosterone Cmax derived from the 4th injection IPK interval | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Mean | Standard Deviation | ng/dL | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Primary | Serum Total Testosterone Concentration at the End of the Dosing Interval Following the 4th Injection in Part C | Serum total testosterone Ctrough derived from the 4th injection IPK interval | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Mean | Standard Deviation | ng/dL | | Day 70 post injection at week 24 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Primary | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 2nd Injection Interval in Part C2 | Success was defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL. | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Number | | percentage of participants | | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | | | | ID | Title | Description |
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| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Primary | Serum Total Testosterone Average Concentration During the 2nd Injection Interval in Part C2 | Serum total testosterone Cavg derived from the 2nd injection IPK interval | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Mean | Standard Deviation | ng/dL | | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | | | | ID | Title | Description |
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| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Primary | Serum Total Testosterone Maximum Concentration During the 2nd Injection Interval in Part C2 | Serum total testosterone Cmax derived from the 2nd injection IPK interval | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Mean | Standard Deviation | ng/dL | | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | | | | ID | Title | Description |
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| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Primary | Serum Total Testosterone at the End of the Dosing Interval Following the 2nd Injection in Part C2 | Serum total testosterone Ctrough derived from the 2nd injection IPK interval | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Mean | Standard Deviation | ng/dL | | Day 70 post injection at week 4 | | | | ID | Title | Description |
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| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Secondary | Serum Total Testosterone Maximum Concentration in Part A | | Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (20 from A-TU 750 mg and 11 from A-TU 1000 mg) | Posted | | Mean | Standard Deviation | ng/dL | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 1, week 12, week 24, and week 36; and post injection at weeks 48, 60, 72, 84, 96, 108, and 120 | | | | ID | Title | Description |
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| OG000 | A-TU 750 mg | 750 mg TU in 3 mL oily solution, IM every 12 weeks for up to 3 years in Part A | | OG001 | A-TU 1000 mg | 1000 mg TU in 4 mL oily solution, IM every 12 weeks for up to 3 years in Part A |
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| Secondary | Serum Total Testosterone Maximum Concentration in Part B | | Total patient sample includes participants who were enrolled and received at least 1 injection; participants without any IPK sample collections were excluded from this analysis (2 from B-TU 750 mg and 12 from B-TU 1000 mg) | Posted | | Mean | Standard Deviation | ng/dL | | Post injection at week 1; post injection at week 8; days 0, 4, 7, 11, 14, 21, 28, 42, 56, 70, and 84 post injection at week 20; and post injection at weeks 32, 44, 56, 68, and 80 | | | | ID | Title | Description |
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| OG000 | B-TU 750 mg | 1000 mg TU in 4 mL oily solution, IM at baseline, and then 750 mg TU in 3 mL oily solution at week 8 and again every 10 weeks for up to 23 months in Part B | | OG001 | B-TU 1000 mg | 1000 mg TU in 4 mL oily solution, IM at baseline, week 8, and then every 12 weeks for up to 24 months in Part B |
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| Secondary | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 3rd Injection Interval in Part C | Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL. | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
|---|
| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 3rd Injection Interval in Part C | | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
|---|
| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With Serum Total Testosterone Average Concentration ≥300 ng/dL During the 3rd Injection Interval in Part C | | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 3rd Injection Interval in Part C | | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations <300 ng/dL were also excluded from analysis | Posted | | Mean | Standard Deviation | days | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With Clinical Success During the 3rd Injection Interval in Part C | Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
|---|
| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 3rd Injection Interval in Part C | | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 14, 21, 28, 42, 56, and 70 post injection at week 14 | | | | ID | Title | Description |
|---|
| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration Criteria for Success During the 4th Injection Interval in Part C | Success is defined as having ≥85% of participants with Cmax ≤1500 ng/dL, ≤5% of participants with Cmax 1800-2500 ng/dL, and no participants with Cmax >2500 ng/dL. | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With at Least 1 Serum Total Testosterone Level <300 ng/dL at Any Time During the 4th Injection Interval in Part C | | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
|---|
| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With Average Serum Total Testosterone Concentration ≥300 ng/dL During the 4th Injection Interval in Part C | | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
|---|
| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Time to First Serum Total Testosterone Concentration <300 ng/dL Following the 4th Injection Interval in Part C | | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis); an additional 57 participants who did not have serum total testosterone concentrations <300 ng/dL were also excluded from analysis | Posted | | Mean | Standard Deviation | days | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
|---|
| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With Clinical Success During the 4th Injection Interval in Part C | Clinical success is defined as having both Cavg and Ctrough between 300 and 1000 ng/dL | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
|---|
| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With Serum Total Testosterone Maximum Concentration ≤1500, >1500 to <1800, 1800 to 2500, and >2500 ng/dL During the 4th Injection Interval in Part C | | Steady-state PK population includes all participants in the PK population with non-missing 4th and 5th injection serum total testosterone concentrations (26 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Days 0, 4, 7, 11, 42, and 70 post injection at week 24 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants by Collapsed Category for Each Parameter of the Male Patient Global Assessment (M-PGA) at Day 21 of the 3rd Injection Interval in Part C | M-PGA is a 5-item self-report questionnaire to assess perception of change from pretreatment or baseline in hypogonadal symptoms including confidence/self-esteem, sexual performance, moods/behavior, overall feeling of well-being, and satisfaction with study treatment rated on a 7-point scale where items 1-4 were rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), 7 (very much worse) and item 5 was rated as 1 (very much satisfied), 2 (much satisfied), 3 (minimally satisfied), 4 (neither satisfied nor dissatisfied), 5 (minimally dissatisfied), 6 (much dissatisfied), 7 (very much dissatisfied). Collapsed ratings: Improved=Very much, much, or minimally improved; Worsened=Very much, much, or minimally worse; No change; Satisfied=Very much, much, or minimally satisfied; Not satisfied=Very much, much, or minimally dissatisfied; No opinion (neither satisfied nor dissatisfied). | Pharmacokinetic (PK) population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis) | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 21 post injection at week 14 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Change in Body Mass Index From Baseline to Week 24 in Part C | Difference in Body Mass Index (BMI) from baseline to week 24 calculated from weight (kg) divided by height squared (m2) | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis | Posted | | Mean | Standard Deviation | kg/m2 | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Change in Weight From Baseline to Week 24 in Part C | | PK population includes participants who had a minimum of 4 serum total testosterone concentration values within the 3rd injection interval (13 participants were excluded from analysis); 1 additional participant did not have a measurement at week 24 and was also excluded from analysis | Posted | | Mean | Standard Deviation | kg | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | C-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 20 months in Part C |
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| Secondary | Percentage of Participants With at Least 1 Serum Total Testosterone Concentration >1000, >1100, >1250, and <300 or >1000 ng/dL During the 2nd Injection Interval in Part C2 | | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Number | | percentage of participants | | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | | | | ID | Title | Description |
|---|
| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Secondary | Serum Dihydrotestosterone Concentrations During the 2nd Injection Interval in Part C2 | | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Mean | Standard Deviation | pg/mL | | Days 0, 4, 7, 11, 14, and 70 post injection at week 4 | | | | ID | Title | Description |
|---|
| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Secondary | Serum Total Testosterone Concentrations in Part C2 | | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Mean | Standard Deviation | ng/dL | | Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44 | | | | ID | Title | Description |
|---|
| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Secondary | Percentage of Participants With Serum Total Testosterone Concentrations Outside the Normal Range in Part C2 | Serum total testosterone concentrations outside the normal range are categorized as <300 ng/dL (below lower limit of normal range) and >1000 ng/dL (above upper limit of normal range) | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Number | | percentage of participants | | Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; weeks 14, 24, 34, and 44 | | | | ID | Title | Description |
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| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Secondary | Trough Assessments of Serum Total Testosterone Concentrations in Part C2 | | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Mean | Standard Deviation | ng/dL | | Screening; day 0; and weeks 4, 14, 24, 34, and 44 | | | | ID | Title | Description |
|---|
| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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| Secondary | Serum Total Testosterone Maximum Concentration in Part C2 | | Total patient sample/PK sample includes participants who were enrolled, received injection 2, and had at least 1 post-injection 2 IPK sample (no participants were excluded) | Posted | | Mean | Standard Deviation | ng/dL | | Screening; day 0; days 0, 4, 7, 11, and 14 post injection at week 4; and weeks 14, 24, 34, and 44 | | | | ID | Title | Description |
|---|
| OG000 | C2-TU 750 mg | 750 mg TU in 3 mL oily solution, IM at baseline, week 4, and then every 10 weeks for up to 12 months in Part C2 |
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