| Primary | Change in Standardized Rate of Apheresis Treatments From Week 7 to Week 18 | Rate of apheresis treatments were normalized by the number of planned apheresis treatments according to each participant's established schedule at screening, week -10 to week -2. The normalized rate of apheresis was defined for each participant as the number of actual apheresis treatments received from week 7 to week 18 divided by the number of planned apheresis treatments per randomization strata at baseline (6 for Q2W and 12 for QW). | Primary intent-to-treat (ITT) population defined as all randomized participants and were analyzed according to the treatment group allocated by randomization. | Posted | | Mean | Standard Deviation | Treatments | | Week 7 to Week 18 (before start of open-label treatment) | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) subcutaneous (SC) injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.806± 0.191
- OG0010.128± 0.242
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Analysis was performed using the ranked analysis of covariance (ANCOVA) model with baseline frequency of the apheresis procedure (QW or Q2W) and Lp(a) levels (normal or elevated) as fixed effect and the baseline LDL-C level as a covariate. Hodges-Lehmann estimator of median difference (median of all pairwise differences; CI is Moses distribution free CI. p-value is derived from the rank-based ANCOVA model. The model includes the baseline LDL-C value and stratification factors per IVRS. | ANCOVA | | < 0.0001 | Threshold for significance at 0.05 level. | H-L estimate of median difference | 0.750 | | | 2-Sided | 95 | 0.667 | 0.833 | | | Alirocumab 150 mg Q2W (Double Blind Period) vs. Placebo Q2W (Double Blind Period) |
|
| Secondary | Percent Change From Baseline in Calculated LDL-C (Pre-apheresis) at Week 6 | Adjusted Least-squares (LS) means and standard errors at Week 6 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 2 to Week 18 regardless of status on or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population that included all randomized particpants with baseline and at least one post-baseline pre-apheresis calculated LDL-C value up to week 6, analyzed according to the treatment group allocated by randomization. | Posted | | Least Squares Mean | Standard Error | percent change in mmol/L | | Baseline and at Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Change in Standardized Rate of Apheresis Treatments From Week 15 to Week 18 | Rate of apheresis treatments were normalized by the rate by the number of actual apheresis treatments according to received from week 15 to week 18 divided by the planned apheresis treatments per randomization strata at baseline (2 for Q2W and 4 for QW). Only legitimate apheresis treatment skipping per point-of-care LDL-C value is counted as "apheresis not occurred". Missing apheresis treatment information (any reason) from week 7 to week 18 is assigned an outcome of the apheresis treatment occurred at the visit (i.e. impute 1 apheresis treatment for that visit). | Analysis was performed on ITT population. | Posted | | Mean | Standard Deviation | Treatments | | Week 15 up to Week 18 (before the start of open-label treatment dose) | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) (Pre-apheresis) to Week 6 | Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) (Pre-apheresis) to Week 6 | Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or biweekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol (Pre-apheresis) to Week 6 | Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein A (Apo A1) (Pre-apheresis) to Week 6 | Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percentage of Participants With At Least (>=) 30% Reduction in Calculated LDL-C (Pre-apheresis) at Week 6 | Percentage of participants at Week 6 was obtained from a last observation carried forward (LOCF) model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percentage of Participants With At Least (>=) 50% Reduction in Calculated LDL-C (Pre-apheresis) at Week 6 | Percentage of participants at Week 6 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or biweekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Calculated LDL-C (Pre-Apheresis) to Week 18 | Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or biweekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) (Pre-apheresis) to Week 18 | Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or biweekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Non-HDL-C (Pre-apheresis) to Week 18 | Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or biweekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Total Cholesterol (Pre-apheresis) to Week 18 | Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or biweekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Apo A1 (Pre-apheresis) to Week 18 | Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or biweekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percentage of Participants With At Least (>=) 30% Reduction in Calculated LDL-C (Pre-apheresis) at Week 18 | Percentage of participants at Week 18 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percentage of Participants With At Least (>=) 50% Reduction in Calculated LDL-C (Pre-apheresis) at Week 18 | Percentage of participants at Week 18 was obtained from LOCF model for handling of missing data. All available post-baseline data regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Number | | percentage of participants | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Change From Baseline in W-BQ22 (Well-being Questionnaire) Index Score at Week 18 | The W-BQ22 (well-being) questionnaire was a standardized and generic instrument used for measuring the impact of hypercholesterolemia and treatment on well-being of participants. The general well-being score was calculated as the sum of 22 questions in the W-BQ22 questionnaire (each question scored from 0 to 3 [0 = not at all and 3 = all the time]). Total score for 22 questions range from 0 to 66 [0 = worst condition and 66 = best well-being condition).](streamdown:incomplete-link) | Analysis was performed on Well-Being analysis set included all randomized and treated participants with complete baseline and complete post-baseline evaluations of the 22-question well-being questionnaire. | Posted | | Least Squares Mean | Standard Error | scores on a scale | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Lipoprotein (a) (Lp [a]) (Pre-apheresis) to Week 6 | Adjusted means and standard errors at Week 6 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) (Pre-apheresis) to Week 6 | Adjusted LS means and standard errors at Week 6 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Triglyceride (TG) Levels (Pre-apheresis) to Week 6 | Adjusted means and standard errors at Week 6 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | percent change | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in Lp (a) (Pre-apheresis) to Week 18 | Adjusted means and standard errors at Week 18 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in HDL-C (Pre-apheresis) to Week 18 | Adjusted LS means and standard errors at Week 18 were obtained from MMRM to account for missing data. All available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |
| Secondary | Percent Change From Baseline in TG Levels (Pre-apheresis) to Week 18 | Adjusted means and standard errors at Week 18 from a multiple imputation approach followed by robust regression model including all available post-baseline data from Week 2 (pre-apheresis) to Week 18 (pre-apheresis) regardless of status on- or off-treatment were used in the model (ITT analysis). | Analysis was performed on ITT population. | Posted | | Least Squares Mean | Standard Error | Percent change | | From Baseline to Week 18 | | | | ID | Title | Description |
|---|
| OG000 | Placebo Q2W (Double Blind Period) | Placebo (for alirocumab) SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. | | OG001 | Alirocumab 150 mg Q2W (Double Blind Period) | Alirocumab 150 mg SC injection Q2W up to Week 16. Apheresis frequency was fixed (weekly or bi-weekly) until Week 6, then it was adjusted according to the response to treatment. |
| |