Disease reactivation requires:1) SELENA-SLEDAI mild/moderate or severe flare,and 2) Increased immunosuppressive therapy on a sustained basis,defined by one of the following criteria:a) Sustained activity:Significant prolonged SLE flare requiring steroid increase/burst to ≥15 mg/day prednisone (or equivalent) for >4 weeks.b) Frequent relapsing/remitting:Participant flares requiring an increase/burst of steroids and is successfully tapered to <15 mg/day within 4 weeks, but this occurs on >2 occasions, or IA, IM or IV steroids on more than1 occasion.c)Clinical activity of sufficient severity to warrant resumption of/increased dose of MMF or addition of other major immunosuppressive including AZA or MTX.Regardless of steroid use, if the investigator observes disease activity of sufficient severity to warrant resumption, addition or increase in dosage of major immunosuppressant in the setting of a SELENA-SLEDAI flare, participant has met the primary endpoint.Risk difference also included

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

The time to clinically significant disease reactivation was defined as the time from Baseline/Day 0 to the date of the first Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) assessment that met (or went on to meet) the criteria for clinically significant disease reactivation. Time to clinically significant disease reactivation was defined in study weeks as: date of SELENA-SLEDAI assessment that met reactivation criteria minus (-) baseline date.

The modified Intent-to-Treat (mITT) population included randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met disease reactivation were analyzed.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the renal subgroup were analyzed.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the non-renal subgroup were analyzed.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

MMF: mycophenolate mofetil

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Baseline MMF <2000 mg/day participants were analyzed.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

MMF: mycophenolate mofetil

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Baseline MMF >=2000 mg/day participants were analyzed

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the renal subgroup were analyzed.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the non-renal subgroup were analyzed.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

MMF: mycophenolate mofetil

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Baseline MMF <2000 mg/day participants were analyzed.

The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

MMF: mycophenolate mofetil

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Baseline MMF >=2000 mg/day participants were analyzed

The time to first mild/moderate or severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first mild/moderate or severe SELENA-SLEDAI flare. Time to SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE.

The modified Intent-to-Treat (mITT) population included randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who had SELENA-SLEDAI flares were analyzed.

The time to first severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first severe SELENA-SLEDAI flare. Time to severe SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE.

The modified Intent-to-Treat (mITT) population included randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who had SELENA-SLEDAI flares were analyzed.

The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the renal subgroup were analyzed.

The SLICC/DI measures accumulated damage that has occurred since the onset of systemic lupus erythematosus (SLE), regardless of cause, in 12 organ systems. SLE damage is defined as an irreversible change in an organ or system that has been present for at least 6 months. The SLICC/DI includes 39 areas of damage in 12 domains, where each item is rated as present or absent; if evidence of damage is present for a particular item, it is given a score of 1. Some items are scored with 2 or 3 points in the case of recurring events or end stage renal disease. The SLICC/DI total score will be computed as the sum of all scores for items indicated as present; scores can range from 0 to 45. Higher scores indicate more damage.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

The addition of aggressive adjunctive therapy could include intravenous (IV) immunoglobulin or rituximab at any point during the participant's study participation. A change in therapy to cytotoxic drug due to flare could include drugs such as cyclophosphamide, etc. A blinded list of study medications was reviewed to identify the addition of aggressive adjunctive therapy or cytotoxic drugs.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

Steroids include medications that code to a medication class which includes the terms "glucocorticoid" or "corticosteroid". Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM). Total cumulative systemic steroid dose, in milligrams, was summarized over the 60 week study period, or until early study termination, for each participant.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

FACIT-Fatigue scale (FS) is a 13-item questionnaire completed by the patient (participant), that provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. A decrease in the FACIT-FS score reflects worse fatigue/quality of life.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

The SF-36 is a 36-item, patient-reported survey of patient health. Higher scores indicate better outcomes while lower scores indicate more disability. The PF score is used to assess changes in physical functioning. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

The SF-36 is a 36-item, patient-reported survey of patient health. Higher scores indicate better outcomes while lower scores indicate more disability. The Physical Component Score is comprised of the Physical Functioning Scale, the Role-Physical Scale, the Bodily Pain Scale, and the General Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life over the preceding 4 weeks. Scores range from 0 (worst QoL) to 100 (best QoL). Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.

For each participant who experienced disease reactivation, time from clinically significant disease reactivation to improvement in BILAG from maximum level (at least an A or B) during the flare was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG improvement. If multiple body systems had a BILAG flare at the visit, then the body system with the most severe score was tracked for improvement; if multiple body systems had the same score (at least an A or B), then just one needed to show improvement.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met primary endpoint were analyzed.

For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to baseline BILAG scores or BILAG C, whichever is worse, was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG recovery.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met primary endpoint were analyzed.

For each participant who experienced disease reactivation, excess systemic steroid dose was summed from the time of clinically significant disease reactivation until the dose returns to pre-flare levels or the end of study participation, whichever occurred first. Excess systemic steroid dose was defined as the total dose given for the flare minus (-) a participant's pre-flare steroid dose. Participants who do not have an increase in their steroid use due to the flare had their excess dose set to zero. Steroids include medications that code to a medication class which includes the terms "glucocorticoid" or "corticosteroid". Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM).

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met primary endpoint were analyzed.

For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to pre-flare steroid dose was calculated in study days as: date of clinically significant disease reactivation minus (-) date of return to pre-flare steroid dose.

The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met primary endpoint were analyzed.

The number of Grade 3, 4, or 5 AEs classified as possibly, probably, or definitely related to SLE. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.

The number of Grade 3, 4, or 5 AEs classified as possibly, probably, or definitely related to MMF. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.

The number of Grade 3, 4, or 5 AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.

The number of SAEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.

The number of AEs classified as infections. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.

The number of malignancies reported as AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.

The number of Grade 3, 4, or 5 hematological AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.

Mortality related to SLE is defined as any death possibly, probably, or definitely related to SLE. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.

All-cause mortality is defined as death from any cause occurring after randomization. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.

The safety population (SP) includes all participants for whom study intervention was initiated.