Trial Outcomes & Findings for PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (NCT NCT01212770)

NCT ID: NCT01212770

Last Updated: 2020-05-06

Results Overview

Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 505 participants
• Primary outcome timeframe: Baseline and Week 16
• Results posted on: 2020-05-06

Participant Flow

The study was conducted at 78 study centers in 16 countries.

This study consisted of a 24-week randomized, double-blind, placebo-controlled phase, a 28-week randomized, double-blind active treatment phase and a 4-year open-label safety phase, for an overall study duration of 5 years.

Participant milestones

Measure	Placebo Participants initially randomized to receive placebo tablets twice daily (BID) in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).	Apremilast 20 mg Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase continued receiving 20 mg apremilast tablets twice daily in the active treatment / long-term safety phase (LTSP).	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.	Placebo / Apremilast 20 mg EE Participants initially randomized to placebo twice daily were re-randomized due to early escape (EE) at Week 16 and began to receive 20 mg apremilast twice a day in the active treatment phase.	Placebo / Apremilast 20 mg XO Participants initially randomized to receive placebo twice daily were re-randomized at Week 24 (XO) to 20 mg apremilast tablets twice daily in the active treatment phase.	Placebo / Apremilast 30 mg EE Participants initially randomized to placebo twice daily were re-randomized due to early escape (EE) at Week 16 began receiving 30 mg apremilast tablets twice daily in the active treatment phase.	Placebo / Apremilast 30 mg XO Participants initially randomized to placebo twice daily were re-randomized at Week 24 to 30 mg apremilast twice daily in the active treatment phase.	Placebo/Apremilast 20 mg (Long-Term Safety Phase) Participants initially randomized to placebo tablets twice daily during the 24-week placebo-controlled phase were re-randomized to 20 mg apremilast tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 20 mg tablets twice daily in active treatment / long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose).	Placebo/Apremilast 30 mg (Long-Term Safety Phase) Participants initially randomized to placebo tablets BID during the 24-week placebo-controlled phase were re-randomized to apremilast 30 mg tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 30 mg tablets twice daily in the active treatment / long-term safety phase.
Placebo-controlled Phase (Week 0 - 24) STARTED	169	169	167	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) Received Treatment	169	169	167	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) Completed Week 16	156	157	156	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) Early Escape at Week 16	97	76	53	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) COMPLETED	146	147	145	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) NOT COMPLETED	23	22	22	0	0	0	0	0	0
Active Treatment Phase (Weeks 25 - 52) STARTED	0	139	138	43	25	47	25	0	0
Active Treatment Phase (Weeks 25 - 52) COMPLETED	0	120	126	32	23	44	23	0	0
Active Treatment Phase (Weeks 25 - 52) NOT COMPLETED	0	19	12	11	2	3	2	0	0
Long-term Safety Phase (Year 2) STARTED	0	111	121	0	0	0	0	51	64
Long-term Safety Phase (Year 2) COMPLETED	0	88	106	0	0	0	0	42	50
Long-term Safety Phase (Year 2) NOT COMPLETED	0	23	15	0	0	0	0	9	14
Long-term Safety Phase (Year 3) STARTED	0	87	105	0	0	0	0	42	49
Long-term Safety Phase (Year 3) COMPLETED	0	76	94	0	0	0	0	35	44
Long-term Safety Phase (Year 3) NOT COMPLETED	0	11	11	0	0	0	0	7	5
Long-term Safety Phase (Year 4) STARTED	0	77	94	0	0	0	0	35	44
Long-term Safety Phase (Year 4) COMPLETED	0	71	83	0	0	0	0	32	42
Long-term Safety Phase (Year 4) NOT COMPLETED	0	6	11	0	0	0	0	3	2
Long-term Safety Phase (Year 5) STARTED	0	70	83	0	0	0	0	32	42
Long-term Safety Phase (Year 5) COMPLETED	0	68	72	0	0	0	0	30	41
Long-term Safety Phase (Year 5) NOT COMPLETED	0	2	11	0	0	0	0	2	1

Reasons for withdrawal

Measure	Placebo Participants initially randomized to receive placebo tablets twice daily (BID) in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).	Apremilast 20 mg Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase continued receiving 20 mg apremilast tablets twice daily in the active treatment / long-term safety phase (LTSP).	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase continued receiving 30 mg apremilast tablets twice daily in the active treatment / long-term safety phase.	Placebo / Apremilast 20 mg EE Participants initially randomized to placebo twice daily were re-randomized due to early escape (EE) at Week 16 and began to receive 20 mg apremilast twice a day in the active treatment phase.	Placebo / Apremilast 20 mg XO Participants initially randomized to receive placebo twice daily were re-randomized at Week 24 (XO) to 20 mg apremilast tablets twice daily in the active treatment phase.	Placebo / Apremilast 30 mg EE Participants initially randomized to placebo twice daily were re-randomized due to early escape (EE) at Week 16 began receiving 30 mg apremilast tablets twice daily in the active treatment phase.	Placebo / Apremilast 30 mg XO Participants initially randomized to placebo twice daily were re-randomized at Week 24 to 30 mg apremilast twice daily in the active treatment phase.	Placebo/Apremilast 20 mg (Long-Term Safety Phase) Participants initially randomized to placebo tablets twice daily during the 24-week placebo-controlled phase were re-randomized to 20 mg apremilast tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 20 mg tablets twice daily in active treatment / long-term safety phase. (After 30 mg apremilast BID was identified as the optimal dose, all participants receiving 20 mg apremilast BID were switched to the 30 mg apremilast BID dose).	Placebo/Apremilast 30 mg (Long-Term Safety Phase) Participants initially randomized to placebo tablets BID during the 24-week placebo-controlled phase were re-randomized to apremilast 30 mg tablets twice daily at Week 16 or Week 24 and continued receiving apremilast 30 mg tablets twice daily in the active treatment / long-term safety phase.
Placebo-controlled Phase (Week 0 - 24) Adverse Event	10	12	8	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) Lack of Efficacy	6	5	7	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) Withdrawal by Subject	3	4	1	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) Lost to Follow-up	1	0	3	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) Protocol Violation	0	0	1	0	0	0	0	0	0
Placebo-controlled Phase (Week 0 - 24) Miscellaneous	3	1	2	0	0	0	0	0	0
Active Treatment Phase (Weeks 25 - 52) Adverse Event	0	6	2	2	0	0	1	0	0
Active Treatment Phase (Weeks 25 - 52) Lack of Efficacy	0	7	5	4	1	2	0	0	0
Active Treatment Phase (Weeks 25 - 52) Withdrawal by Subject	0	6	3	3	1	1	1	0	0
Active Treatment Phase (Weeks 25 - 52) Lost to Follow-up	0	0	1	0	0	0	0	0	0
Active Treatment Phase (Weeks 25 - 52) Protocol Violation	0	0	0	1	0	0	0	0	0
Active Treatment Phase (Weeks 25 - 52) Miscellaneous	0	0	1	1	0	0	0	0	0
Long-term Safety Phase (Year 2) Adverse Event	0	3	3	0	0	0	0	0	2
Long-term Safety Phase (Year 2) Lack of Efficacy	0	6	7	0	0	0	0	4	6
Long-term Safety Phase (Year 2) Non-compliance to study drug	0	1	0	0	0	0	0	0	0
Long-term Safety Phase (Year 2) Withdrawal by Subject	0	9	3	0	0	0	0	4	4
Long-term Safety Phase (Year 2) Lost to Follow-up	0	2	1	0	0	0	0	1	1
Long-term Safety Phase (Year 2) Miscellaneous	0	2	1	0	0	0	0	0	1
Long-term Safety Phase (Year 3) Adverse Event	0	2	2	0	0	0	0	2	1
Long-term Safety Phase (Year 3) Lack of Efficacy	0	3	4	0	0	0	0	2	2
Long-term Safety Phase (Year 3) Withdrawal by Subject	0	3	4	0	0	0	0	1	1
Long-term Safety Phase (Year 3) Lost to Follow-up	0	1	0	0	0	0	0	0	0
Long-term Safety Phase (Year 3) Protocol Violation	0	0	0	0	0	0	0	1	0
Long-term Safety Phase (Year 3) Miscellaneous	0	2	1	0	0	0	0	1	1
Long-term Safety Phase (Year 4) Adverse Event	0	1	1	0	0	0	0	0	1
Long-term Safety Phase (Year 4) Lack of Efficacy	0	1	5	0	0	0	0	2	0
Long-term Safety Phase (Year 4) Non-compliance with study drug	0	1	1	0	0	0	0	1	0
Long-term Safety Phase (Year 4) Withdrawal by Subject	0	2	3	0	0	0	0	0	0
Long-term Safety Phase (Year 4) Lost to Follow-up	0	0	1	0	0	0	0	0	0
Long-term Safety Phase (Year 4) Miscellaneous	0	1	0	0	0	0	0	0	1
Long-term Safety Phase (Year 5) Missing	0	0	1	0	0	0	0	0	0
Long-term Safety Phase (Year 5) Miscellaneous	0	0	3	0	0	0	0	0	0
Long-term Safety Phase (Year 5) Adverse Event	0	0	2	0	0	0	0	0	1
Long-term Safety Phase (Year 5) Lack of Efficacy	0	0	4	0	0	0	0	0	0
Long-term Safety Phase (Year 5) Withdrawal by Subject	0	2	1	0	0	0	0	1	0
Long-term Safety Phase (Year 5) Death	0	0	0	0	0	0	0	1	0

Baseline Characteristics

PALACE 3: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

Baseline characteristics by cohort

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Total n=505 Participants Total of all reporting groups
Age, Continuous	49.5 years STANDARD_DEVIATION 11.64 • n=5 Participants	49.6 years STANDARD_DEVIATION 12.10 • n=7 Participants	49.9 years STANDARD_DEVIATION 11.38 • n=5 Participants	49.7 years STANDARD_DEVIATION 11.69 • n=4 Participants
Sex: Female, Male Female	91 Participants n=5 Participants	90 Participants n=7 Participants	88 Participants n=5 Participants	269 Participants n=4 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	79 Participants n=7 Participants	79 Participants n=5 Participants	236 Participants n=4 Participants
Duration of psoriatic arthritis	6.78 years STANDARD_DEVIATION 6.463 • n=5 Participants	7.74 years STANDARD_DEVIATION 7.690 • n=7 Participants	7.48 years STANDARD_DEVIATION 7.646 • n=5 Participants	7.33 years STANDARD_DEVIATION 7.284 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set consisting of all participants randomized as specified in the protocol. Participants who withdrew early or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.

Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16	18.3 percentage of participants	28.4 percentage of participants	40.7 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; Last observation carried forward (LOCF) imputation was used.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.

Outcome measures

Measure	Placebo n=163 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=163 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=160 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16	-0.065 units on a scale Standard Error 0.0335	-0.131 units on a scale Standard Error 0.0337	-0.192 units on a scale Standard Error 0.0339	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.

Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With an ACR 20 Response at Week 24	15.4 percentage of participants	26.6 percentage of participants	31.1 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.

Outcome measures

Measure	Placebo n=163 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=164 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=161 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24	-0.053 units on a scale Standard Error 0.0350	-0.137 units on a scale Standard Error 0.0351	-0.192 units on a scale Standard Error 0.0353	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.

The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.

Outcome measures

Measure	Placebo n=162 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=162 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=160 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16	1.14 units on a scale Standard Error 0.589	2.29 units on a scale Standard Error 0.592	3.47 units on a scale Standard Error 0.594	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.

Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16	27.2 percentage of participants	37.9 percentage of participants	52.7 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.

The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 16 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Outcome measures

Measure	Placebo n=89 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=91 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=90 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16	7.9 percentage of participants	20.9 percentage of participants	22.2 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.

The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.

Outcome measures

Measure	Placebo n=164 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=163 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=161 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Patient's Assessment of Pain at Week 16	-4.9 mm Standard Error 1.79	-8.6 mm Standard Error 1.80	-12.7 mm Standard Error 1.81	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline MASES \> 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 16 are included; LOCF was used.

The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.

Outcome measures

Measure	Placebo n=106 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=93 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=107 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16	-0.7 units on a scale Standard Error 0.27	-0.7 units on a scale Standard Error 0.29	-1.0 units on a scale Standard Error 0.27	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set. Participants with a baseline dactylitis severity score \> 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.

Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.

Outcome measures

Measure	Placebo n=67 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=70 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=76 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Dactylitis Severity Score at Week 16	-1.3 units on a scale Standard Error 0.34	-1.7 units on a scale Standard Error 0.33	-2.1 units on a scale Standard Error 0.32	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.

Outcome measures

Measure	Placebo n=159 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=154 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=156 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16	-2.76 units on a scale Standard Error 0.869	-4.61 units on a scale Standard Error 0.886	-7.70 units on a scale Standard Error 0.881	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the distal interphalangeal (DIP) joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

Outcome measures

Measure	Placebo n=163 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=160 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=160 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the Disease Activity Score (DAS28) at Week 16	-0.28 units on a scale Standard Error 0.084	-0.54 units on a scale Standard Error 0.085	-0.74 units on a scale Standard Error 0.085	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 16 are included. LOCF was used.

The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue.

Outcome measures

Measure	Placebo n=160 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=160 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=160 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16	1.18 units on a scale Standard Error 0.640	1.86 units on a scale Standard Error 0.643	3.72 units on a scale Standard Error 0.641	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.

The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.

Outcome measures

Measure	Placebo n=162 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=163 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=161 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24	1.03 units on a scale Standard Error 0.581	2.71 units on a scale Standard Error 0.582	3.37 units on a scale Standard Error 0.585	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.

Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24	23.1 percentage of participants	32.0 percentage of participants	44.3 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; participants with baseline psoriasis involvement ≥ 3% of BSA are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.

The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 24 weeks of treatment. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Outcome measures

Measure	Placebo n=89 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=91 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=90 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24	11.2 percentage of participants	22.2 percentage of participants	25.6 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.

The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.

Outcome measures

Measure	Placebo n=164 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=164 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=162 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Patient's Assessment of Pain at Week 24	-4.4 mm Standard Error 1.75	-8.2 mm Standard Error 1.76	-10.9 mm Standard Error 1.77	—

SECONDARY outcome

Timeframe: Baseline and week 24

Population: Full analysis set; participants with a baseline MASES \> 0 (i.e., pre-existing enthesopathy) and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.

The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.

Outcome measures

Measure	Placebo n=106 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=93 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=107 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24	-0.7 units on a scale Standard Error 0.29	-1.0 units on a scale Standard Error 0.31	-1.1 units on a scale Standard Error 0.29	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set. Participants with a baseline dactylitis severity score \> 0 (i.e., pre-existing dactylitis) and at least 1 postbaseline value at or prior to Week 24 are included. LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.

Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.

Outcome measures

Measure	Placebo n=67 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=71 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=77 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Dactylitis Severity Score at Week 24	-1.3 units on a scale Standard Error 0.35	-1.7 units on a scale Standard Error 0.34	-2.3 units on a scale Standard Error 0.32	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: • 28 tender joint count (TJC), • 28 swollen joint count (SJC), • Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; • Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8; Low Disease Activity: > 2.8 and ≤ 10; Moderate Disease Activity: > 10 and ≤ 22; High Disease Activity: > 22.

Outcome measures

Measure	Placebo n=159 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=156 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=158 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24	-2.53 units on a scale Standard Error 0.889	-5.18 units on a scale Standard Error 0.900	-7.81 units on a scale Standard Error 0.895	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: • 28 tender joint count • 28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; • C-reactive protein (CRP) • Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

Outcome measures

Measure	Placebo n=163 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=161 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=161 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the Disease Activity Score (DAS28) at Week 24	-0.27 units on a scale Standard Error 0.087	-0.57 units on a scale Standard Error 0.088	-0.75 units on a scale Standard Error 0.087	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; participants with a baseline value and at least 1 postbaseline value at or prior to Week 24 are included; LOCF imputation was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16.

The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.

Outcome measures

Measure	Placebo n=161 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=163 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=161 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24	0.83 units on a scale Standard Error 0.652	2.01 units on a scale Standard Error 0.651	3.27 units on a scale Standard Error 0.654	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline MASES \> 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.

Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.

Outcome measures

Measure	Placebo n=109 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=97 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=112 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With MASES Improvement ≥ 20% at Week 16	53.2 percentage of participants	48.5 percentage of participants	54.5 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; participants with a baseline dactylitis severity score \> 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.

Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.

Outcome measures

Measure	Placebo n=71 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=71 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=80 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16	59.2 percentage of participants	66.2 percentage of participants	71.3 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16	29.0 percentage of participants	40.2 percentage of participants	51.5 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; participants with a baseline MASES \> 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.

Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.

Outcome measures

Measure	Placebo n=109 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=97 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=112 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With MASES Improvement ≥ 20% at Week 24	51.4 percentage of participants	51.5 percentage of participants	54.5 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; participants with a baseline dactylitis severity score \> 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.

Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.

Outcome measures

Measure	Placebo n=71 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=71 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=80 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24	60.6 percentage of participants	67.6 percentage of participants	73.8 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.

EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With Good or Moderate EULAR Response at Week 24	20.1 percentage of participants	32.0 percentage of participants	42.5 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.

Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With a ACR 50 Response at Week 16	8.3 percentage of participants	12.4 percentage of participants	15.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Full analysis set; Participants who discontinued early, or who did not have sufficient data for a definitive determination of response status at Week 16 were counted as non-responders.

Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With an ACR 70 Response at Week 16	2.4 percentage of participants	4.7 percentage of participants	3.6 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.

Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With an ACR 50 Response at Week 24	7.7 percentage of participants	13.6 percentage of participants	16.2 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set; Participants who discontinued early, escaped early at Week 16 or who did not have sufficient data for a definitive determination of response status at Week 24 were counted as non-responders.

Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein.

Outcome measures

Measure	Placebo n=169 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=169 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With a ACR 70 Response at Week 24	3.6 percentage of participants	4.1 percentage of participants	5.4 percentage of participants	—

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set; participants with a baseline MASES \> 0 (i.e., pre-existing enthesopathy) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.

Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 16 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.

Outcome measures

Measure	Placebo n=109 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=97 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=112 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a MASES Score of Zero at Week 16	24.8 percentage of participants	19.6 percentage of participants	20.5 percentage of participants	—

SECONDARY outcome

Timeframe: Week 16

Population: Full analysis set; participants with a baseline dactylitis severity score \> 0 (i.e., pre-existing dactylitis) are included; LOCF was used. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 16 were counted as non-responders.

Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 16 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.

Outcome measures

Measure	Placebo n=71 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=71 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=80 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16	35.2 percentage of participants	40.8 percentage of participants	41.3 percentage of participants	—

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set; participants with a baseline MASES \> 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.

Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks of treatment. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.

Outcome measures

Measure	Placebo n=109 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=97 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=112 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a MASES Score of Zero at Week 24	28.4 percentage of participants	20.6 percentage of participants	27.7 percentage of participants	—

SECONDARY outcome

Timeframe: Week 24

Population: Full analysis set; participants with a baseline dactylitis severity score \> 0 are included; LOCF was used. The Week 16 value was carried over to Week 24 for participants who escaped early at Week 16. Participants who did not have sufficient data (observed or imputed) for a determination of response status at Week 24 were counted as non-responders.

Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 24 weeks of treatment. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.

Outcome measures

Measure	Placebo n=71 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=71 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=80 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24	36.6 percentage of participants	45.1 percentage of participants	46.3 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population consists of all participants who were randomized or re-randomized to apremilast at any time during the study. Only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.

Percentage of participants with an American College of Rheumatology 20% (ACR20) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in 78 tender joint count; • ≥ 20% improvement in 76 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=54 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=67 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=116 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=127 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With an ACR 20 Response at Week 52	59.3 percentage of participants Interval 45.0 to 72.4	58.2 percentage of participants Interval 45.5 to 70.2	56.0 percentage of participants Interval 46.5 to 65.2	63.0 percentage of participants Interval 54.0 to 71.4

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.

Outcome measures

Measure	Placebo n=55 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=67 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=122 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=127 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52	-0.34 units on a scale Standard Deviation 0.407	-0.34 units on a scale Standard Deviation 0.491	-0.33 units on a scale Standard Deviation 0.505	-0.35 units on a scale Standard Deviation 0.505

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.

The Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) is a self-administered instrument that measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). Norm-based scores were used in analyses, calibrated so that 50 is the average score and the standard deviation equals 10. Higher scores indicate a higher level of functioning. The physical functioning domain assesses limitations in physical activities because of health problems. A positive change from Baseline score indicates an improvement.

Outcome measures

Measure	Placebo n=55 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=66 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=121 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=127 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52	7.76 units on a scale Standard Deviation 8.236	6.87 units on a scale Standard Deviation 7.241	5.68 units on a scale Standard Deviation 8.467	5.87 units on a scale Standard Deviation 8.008

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.

Modified PsARC response is defined as improvement in at least 2 of the 4 measures, at least one of which must be tender joint count or swollen joint count, and no worsening in any of the 4 measures: • 78 tender joint count, • 76 swollen joint count, • Patient global assessment of disease activity, measured on a 100 mm visual Analog scale (VAS), where 0 mm = lowest disease activity and 100 mm = highest; • Physician global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. Improvement or worsening in joint counts is defined as decrease or increase, respectively, from baseline by ≥ 30%, and improvement or worsening in global assessments is defined as decrease or increase, respectively, from baseline by ≥ 20 mm VAS. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=53 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=66 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=116 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=124 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With a Modified PsARC Response at Week 52	81.1 percentage of participants Interval 68.0 to 90.6	75.8 percentage of participants Interval 63.6 to 85.5	71.6 percentage of participants Interval 62.4 to 79.5	79.0 percentage of participants Interval 70.8 to 85.8

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with Baseline Psoriasis Body Surface Area ≥ 3% and a Week 52 value are included.

The percentage of participants with Baseline psoriasis body surface area (BSA) involvement ≥ 3% who achieved 75% or greater improvement from Baseline in Psoriasis Area and Severity Index (PASI) score after 52 weeks. The Psoriasis Area and Severity Index (PASI) score is a combination of the intensity of psoriasis, assessed by erythema (reddening), induration (plaque thickness) and desquamation (scaling) scored on a scale from 0 (none) to 4 (very severe), together with the percentage of the area affected, rated on a scale from 0 (no involvement) to 6 (90% to 100% involvement). PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=24 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=35 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=63 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=64 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52	33.3 percentage of participants Interval 15.6 to 55.3	28.6 percentage of participants Interval 14.6 to 46.3	28.6 percentage of participants Interval 17.9 to 41.3	39.1 percentage of participants Interval 27.1 to 52.1

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.

The participant was asked to place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (score = 0 mm) represents "no pain," and the right-hand boundary (score = 100 mm) represents "pain as severe as can be imagined." The distance from the mark to the left-hand boundary was recorded in millimeters.

Outcome measures

Measure	Placebo n=55 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=66 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=122 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=127 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the Patient Assessment of Pain at Week 52	-19.9 mm Standard Deviation 24.54	-19.1 mm Standard Deviation 26.95	-14.9 mm Standard Deviation 24.86	-18.7 mm Standard Deviation 27.01

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value \> 0 (i.e., pre-existing enthesopathy) and a Week 52 value are included.

The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses.

Outcome measures

Measure	Placebo n=34 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=48 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=66 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=87 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52	-2.5 units on a scale Standard Deviation 3.10	-2.2 units on a scale Standard Deviation 3.01	-2.2 units on a scale Standard Deviation 2.98	-1.9 units on a scale Standard Deviation 2.99

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline value \> 0 (i.e., pre-existing dactylitis) and a Week 52 value are included.

Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet will be rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present.

Outcome measures

Measure	Placebo n=22 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=26 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=52 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=61 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the Dactylitis Severity Score at Week 52	-3.1 units on a scale Standard Deviation 4.26	-3.8 units on a scale Standard Deviation 4.52	-2.9 units on a scale Standard Deviation 3.67	-3.6 units on a scale Standard Deviation 4.30

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the: •28 tender joint count (TJC), •28 swollen joint count (SJC), •Patient's Global Assessment of Disease Activity measured on a 10 cm visual analog scale (VAS), where 0 cm = lowest disease activity and 10 cm = highest; •Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. The following thresholds of disease activity have been defined for the CDAI: Remission: ≤ 2.8 Low Disease Activity: > 2.8 and ≤ 10 Moderate Disease Activity: > 10 and ≤ 22 High Disease Activity: > 22.

Outcome measures

Measure	Placebo n=53 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=66 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=116 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=124 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the CDAI Score at Week 52	-13.54 units on a scale Standard Deviation 10.689	-12.38 units on a scale Standard Deviation 10.308	-12.86 units on a scale Standard Deviation 12.654	-14.14 units on a scale Standard Deviation 11.354

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: •28 tender joint count •28 swollen joint count, which do not include the DIP joints, the hip joint, or the joints below the knee; •C-reactive protein (CRP) •Patient's global assessment of disease activity. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

Outcome measures

Measure	Placebo n=54 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=67 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=121 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=127 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the DAS28 at Week 52	-1.28 units on a scale Standard Deviation 1.102	-1.29 units on a scale Standard Deviation 1.156	-1.21 units on a scale Standard Deviation 1.063	-1.41 units on a scale Standard Deviation 1.204

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a Baseline value and a Week 52 value are included.

The FACIT-Fatigue scale is a 13-item self-administered questionnaire that assesses both the physical and functional consequences of fatigue. Each question is answered on a 5-point scale, where 0 means "not at all," and 4 means "very much." The FACIT-Fatigue scale score ranges from 0 to 52, with higher scores denoting lower levels of fatigue. A positive change from baseline score indicates an improvement.

Outcome measures

Measure	Placebo n=54 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=65 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=121 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=127 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Change From Baseline in the FACIT-Fatigue Scale Score at Week 52	6.72 units on a scale Standard Deviation 8.996	5.66 units on a scale Standard Deviation 8.738	4.78 units on a scale Standard Deviation 8.526	6.20 units on a scale Standard Deviation 8.679

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; participants with a baseline MASES \> 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.

Percentage of participants with pre-existing enthesopathy whose MASES improved by ≥ 20% from Baseline after 52 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=34 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=48 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=66 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=87 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With MASES Improvement ≥ 20% at Week 52	73.5 percentage of participants Interval 55.6 to 87.1	75.0 percentage of participants Interval 60.4 to 86.4	77.3 percentage of participants Interval 65.3 to 86.7	71.3 percentage of participants Interval 60.6 to 80.5

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score \> 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.

Percentage of participants with pre-existing dactylitis whose dactylitis severity score improved by ≥ 1 after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=22 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=26 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=52 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=61 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52	95.5 percentage of participants Interval 77.2 to 99.9	92.3 percentage of participants Interval 74.9 to 99.1	88.5 percentage of participants Interval 76.6 to 95.6	91.8 percentage of participants Interval 81.9 to 97.3

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.

A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either: • an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of less than or equal to 5.1 or, • an improvement (decrease) in the DAS28 of more than 1.2 and attainment of a DAS28 score of greater than 3.2. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=54 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=67 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=121 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=127 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52	64.8 percentage of participants	73.1 percentage of participants	69.4 percentage of participants	74.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.

Percentage of participants with an American College of Rheumatology 50% (ACR50) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 50% improvement in 78 tender joint count; • ≥ 50% improvement in 76 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=53 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=66 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=119 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=126 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With an ACR 50 Response at Week 52	28.3 percentage of participants Interval 16.8 to 42.3	31.8 percentage of participants Interval 20.9 to 44.4	25.2 percentage of participants Interval 17.7 to 34.0	30.2 percentage of participants Interval 22.3 to 39.0

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants who had sufficient data for a definitive determination of response status at Week 52 are included.

Percentage of participants with an American College of Rheumatology 70% (ACR70) response. A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 70% improvement in 78 tender joint count; • ≥ 70% improvement in 76 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); ◦ C-Reactive Protein. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=53 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=67 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=120 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=125 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants With an ACR 70 Response at Week 52	20.8 percentage of participants Interval 10.8 to 34.1	14.9 percentage of participants Interval 7.4 to 25.7	9.2 percentage of participants Interval 4.7 to 15.8	10.4 percentage of participants Interval 5.7 to 17.1

SECONDARY outcome

Timeframe: Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; only those participants with a baseline value \> 0 (i.e., pre-existing enthesopathy) and who had sufficient data for a definitive determination of response status at Week 52 are included.

Percentage of participants with pre-existing enthesopathy whose MASES improves to 0 after 24 weeks. The Maastricht Ankylosing Spondylitis Enthesitis Score quantitates inflammation of the entheses (enthesitis) by assessing pain at the following entheses (sites where tendons or ligaments insert into the bone): 1st costochondral joints left/right; 7th costochondral joints left/right; posterior superior iliac spine left/right; anterior superior iliac spine left/right; iliac crest left/right; 5th lumbar spinous process; and the proximal insertion of the Archilles tendon left/right. The MASES, ranging from 0 to 13, is the number of painful entheses out of 13 entheses. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=34 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=48 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=66 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=87 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a MASES Score of Zero at Week 52	44.1 percentage of participants Interval 27.2 to 62.1	43.8 percentage of participants Interval 29.5 to 58.8	33.3 percentage of participants Interval 22.2 to 46.0	36.8 percentage of participants Interval 26.7 to 47.8

SECONDARY outcome

Timeframe: Week 52

Population: The Apremilast Subjects as Randomized/Re-randomized (AAR) Population; Participants with a baseline dactylitis severity score \> 0 (i.e., pre-existing dactylitis) and who had sufficient data for a definitive determination of response status at Week 52 are included.

Percentage of participants with pre-existing dactylitis whose dactylitis severity score improves to zero after 52 weeks. Dactylitis is characterized by swelling of the entire finger or toe. Each digit on the hands and feet was rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Two-sided 95% confidence interval is based on the Clopper-Pearson method.

Outcome measures

Measure	Placebo n=22 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=26 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=52 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg n=61 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52	68.2 percentage of participants Interval 45.1 to 86.1	80.8 percentage of participants Interval 60.6 to 93.4	75.0 percentage of participants Interval 61.1 to 86.0	68.9 percentage of participants Interval 55.7 to 80.1

SECONDARY outcome

Timeframe: Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants (placebo participants who remained on placebo through week 24 and participants randomized to the APR 20 mg BID or APR 30 mg BID)

Population: Safety population = participants who received at least one dose of IP;1 participant randomized to 30 mg APR who received PBO in error is counted in the PBO group;1 participant randomized to PBO who received 30 mg APR in error is counted in the 30 mg group;1 participant randomized to PBO who received 20 mg APR in error is counted in the 20 mg group

A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.

Outcome measures

Measure	Placebo n=168 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=170 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=167 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase Any TEAE	83 participants	100 participants	104 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase Any Drug-Related TEAE	33 participants	50 participants	62 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase Any Severe TEAE	8 participants	5 participants	10 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase Any Serious TEAE (SAE)	9 participants	3 participants	6 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase Any Serious Drug-Related TEAE	2 participants	0 participants	0 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase Any TEAE Leading to Drug Interruption	4 participants	20 participants	16 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase Any TEAE Leading to Drug Withdrawal	10 participants	13 participants	12 participants	—
Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-Controlled Phase Any TEAE Leading to Death	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Week 0 to Week 260; median duration of exposure to apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg BID

Population: Apremilast Subjects as Treated (AAT) were those who received at least 1 dose of apremilast at any time during the study. Participants were included in the treatment group corresponding to the apremilast dosing regimen they actually received, irrespective of the treatment group to which they were randomized or re-randomized.

A TEAE is an adverse event (AE) with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. A serious AE is any AE that results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or constitutes an important medical event. For both AEs and SAEs the investigator assessed the severity of the event according to the grading scale: Mild: asymptomatic or with mild symptoms, Moderate: symptoms causing moderate discomfort or Severe: symptoms causing severe discomfort or pain.

Outcome measures

Measure	Placebo n=241 Participants Participants initially randomized to receive placebo tablets twice daily.	Apremilast 20 mg n=97 Participants Participants initially randomized to receive 20 mg apremilast tablets twice daily.	Apremilast 30 mg n=242 Participants Participants initially randomized to receive 30 mg apremilast tablets twice daily.	Apremilast 30 mg Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period Any Drug-Related TEAE	98 participants	11 participants	111 participants	—
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period Any Severe TEAE	21 participants	0 participants	30 participants	—
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period Any TEAE Leading to Drug Interruption	48 participants	4 participants	53 participants	—
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period Any Serious TEAE (SAE)	38 participants	4 participants	54 participants	—
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period Any Serious Drug-Related TEAE	5 participants	0 participants	3 participants	—
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period Any TEAE Leading to Drug Withdrawal	30 participants	0 participants	30 participants	—
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period Any TEAE Leading to death	0 participants	1 participants	0 participants	—
Number of Participants With Treatment Emergent Adverse Events During the Apremilast Exposure Period Any TEAE	194 participants	64 participants	209 participants	—

Adverse Events

Weeks 0-24: Placebo (Placebo-Controlled Phase)

Serious events: 9 serious events

Other events: 35 other events

Deaths: 0 deaths

Weeks 0-24: Apremilast 20 mg (Placebo- Controlled Phase)

Serious events: 4 serious events

Other events: 66 other events

Deaths: 0 deaths

Weeks 0-24: Apremilast 30 mg (Placebo- Controlled Phase)

Serious events: 6 serious events

Other events: 71 other events

Deaths: 0 deaths

APR Exposure Period Up to 5 Years: Apremilast 20 mg

Serious events: 38 serious events

Other events: 142 other events

Deaths: 0 deaths

APR Exposure Period Up to 5 Years: Apremilast 20mg/30 mg

Serious events: 4 serious events

Other events: 36 other events

Deaths: 0 deaths

APR Exposure Period Up to 5 Years: Apremilast 30 mg

Serious events: 54 serious events

Other events: 164 other events

Deaths: 0 deaths

Serious adverse events

Measure	Weeks 0-24: Placebo (Placebo-Controlled Phase) n=168 participants at risk Participants received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.	Weeks 0-24: Apremilast 20 mg (Placebo- Controlled Phase) n=170 participants at risk Participants received 20 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.	Weeks 0-24: Apremilast 30 mg (Placebo- Controlled Phase) n=167 participants at risk Participants received 30 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.	APR Exposure Period Up to 5 Years: Apremilast 20 mg n=241 participants at risk Participants who received apremilast 20 mg twice daily regardless of when the apremilast exposure started (at Week 0, 16 or 24). Only TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.	APR Exposure Period Up to 5 Years: Apremilast 20mg/30 mg n=97 participants at risk Participants who switched from apremilast 20 mg twice daily to apremilast 30 mg BID. Only the TEAEs that occurred during apremilast 30 mg twice daily treatment were included.	APR Exposure Period Up to 5 Years: Apremilast 30 mg n=242 participants at risk Participants who received apremilast 30 mg twice daily throughout the study regardless of when the apremilast-exposure started (at Week 0, 16, or 24).
Blood and lymphatic system disorders Anaemia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Acute myocardial infarction	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Angina pectoris	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Angina unstable	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.83% 2/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.83% 2/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Atrial fibrillation	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Atrioventricular block complete	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Cardiac failure	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Coronary artery disease	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Myocardial infarction	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Myocardial ischaemia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Sick sinus syndrome	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Cardiac disorders Supraventricular tachycardia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Congenital, familial and genetic disorders Arteriovenous malformation	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Congenital, familial and genetic disorders Pulmonary arteriovenous fistula	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Ear and labyrinth disorders Meniere's disease	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Endocrine disorders Acromegaly	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Gastrointestinal disorders Abdominal hernia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Gastrointestinal disorders Colonic polyp	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Gastrointestinal disorders Intestinal polyp	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Gastrointestinal disorders Pancreatitis acute	1.2% 2/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
General disorders Chest pain	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
General disorders Impaired healing	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
General disorders Non-cardiac chest pain	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
General disorders Pyrexia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Hepatobiliary disorders Cholecystitis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Hepatobiliary disorders Cholelithiasis	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Anal abscess	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Appendicitis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Bronchitis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Cellulitis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Cholecystitis infective	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Chronic sinusitis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Erysipelas	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Lobar pneumonia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Pneumonia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.83% 2/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Pneumonia bacterial	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Rhinitis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Toxic shock syndrome	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Urinary tract infection	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Urosepsis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.59% 1/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Ankle fracture	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Cerebral haemorrhage traumatic	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Concussion	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Contusion	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Head injury	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Meniscus lesion	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Procedural complication	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Snake bite	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Tibia fracture	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Injury, poisoning and procedural complications Whiplash injury	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Investigations Blood pressure increased	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Finger deformity	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.2% 3/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.83% 2/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Psoriatic arthropathy	1.2% 2/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.59% 1/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.83% 2/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.9% 7/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.59% 1/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage III	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncocytoma	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Cerebrovascular accident	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Intracranial aneurysm	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Ischaemic stroke	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Loss of consciousness	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Migraine	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Polyneuropathy	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Transient ischaemic attack	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Psychiatric disorders Anxiety	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Psychiatric disorders Mental disorder	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Psychiatric disorders Suicidal ideation	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.59% 1/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.83% 2/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Renal and urinary disorders Calculus ureteric	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Renal and urinary disorders Calculus urinary	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Renal and urinary disorders Nephrolithiasis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Reproductive system and breast disorders Breast enlargement	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Reproductive system and breast disorders Ovarian haemorrhage	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Skin and subcutaneous tissue disorders Angioedema	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Skin and subcutaneous tissue disorders Urticaria	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Surgical and medical procedures Alcohol rehabilitation	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Vascular disorders Arterial thrombosis limb	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Vascular disorders Hypertension	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.83% 2/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Vascular disorders Hypertensive crisis	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Vascular disorders Thrombophlebitis	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.41% 1/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.

Other adverse events

Measure	Weeks 0-24: Placebo (Placebo-Controlled Phase) n=168 participants at risk Participants received placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.	Weeks 0-24: Apremilast 20 mg (Placebo- Controlled Phase) n=170 participants at risk Participants received 20 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.	Weeks 0-24: Apremilast 30 mg (Placebo- Controlled Phase) n=167 participants at risk Participants received 30 mg apremilast tablets PO twice daily during the 24-week placebo-controlled phase.	APR Exposure Period Up to 5 Years: Apremilast 20 mg n=241 participants at risk Participants who received apremilast 20 mg twice daily regardless of when the apremilast exposure started (at Week 0, 16 or 24). Only TEAEs that occurred during apremilast 20 mg BID treatment (before the switch to 30 mg apremilast) were included.	APR Exposure Period Up to 5 Years: Apremilast 20mg/30 mg n=97 participants at risk Participants who switched from apremilast 20 mg twice daily to apremilast 30 mg BID. Only the TEAEs that occurred during apremilast 30 mg twice daily treatment were included.	APR Exposure Period Up to 5 Years: Apremilast 30 mg n=242 participants at risk Participants who received apremilast 30 mg twice daily throughout the study regardless of when the apremilast-exposure started (at Week 0, 16, or 24).
Gastrointestinal disorders Diarrhoea	1.8% 3/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	15.3% 26/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	15.6% 26/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	16.6% 40/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	18.2% 44/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Gastrointestinal disorders Nausea	5.4% 9/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	11.2% 19/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	13.8% 23/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	11.6% 28/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	3.1% 3/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	19.4% 47/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Gastrointestinal disorders Vomiting	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.9% 5/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	4.8% 8/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	4.1% 10/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	5.8% 14/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
General disorders Fatigue	1.2% 2/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.8% 3/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	4.8% 8/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.5% 6/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	6.6% 16/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Bronchitis	1.2% 2/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.8% 3/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	7.1% 17/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	3.1% 3/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	8.3% 20/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Nasopharyngitis	1.2% 2/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	4.1% 7/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.4% 4/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	14.1% 34/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	12.4% 12/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	14.9% 36/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Pharyngitis	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.59% 1/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.60% 1/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	5.8% 14/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	5.8% 14/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Sinusitis	1.8% 3/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.4% 4/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.4% 4/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	5.0% 12/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	7.4% 18/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Upper respiratory tract infection	1.8% 3/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	6.5% 11/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	7.2% 12/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	14.1% 34/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	6.2% 6/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	14.9% 36/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Infections and infestations Urinary tract infection	0.60% 1/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.2% 2/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	3.0% 5/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	7.9% 19/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	3.1% 3/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	9.1% 22/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Arthralgia	1.8% 3/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.2% 2/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.4% 4/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	3.7% 9/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	7.9% 19/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Musculoskeletal and connective tissue disorders Back pain	1.8% 3/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.59% 1/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	5.0% 12/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	4.1% 4/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	7.4% 18/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Nervous system disorders Headache	4.8% 8/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	9.4% 16/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	12.0% 20/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	12.4% 30/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	4.1% 4/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	16.1% 39/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Psychiatric disorders Insomnia	2.4% 4/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.59% 1/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.2% 2/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.83% 2/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	0.00% 0/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	5.8% 14/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.4% 4/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	3.0% 5/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.5% 6/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.0% 1/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	7.4% 18/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.
Vascular disorders Hypertension	3.0% 5/168 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	1.8% 3/170 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	2.4% 4/167 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	7.1% 17/241 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	3.1% 3/97 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.	9.1% 22/242 • AEs are reported for the placebo-controlled phase from Week 0 to Week 16 for placebo participants who entered EE at Week 16 and up to Week 24 for all other participants and reported for the Apremilast Exposure Period from Week 0 to Week 260; median duration of apremilast 20 mg BID was 121.71 weeks and 232.50 weeks for apremilast 30 mg twice daily One participant randomized to 30 mg apremilast who received placebo in error is counted in the placebo group; one participant randomized to placebo who received 30 mg apremilast in error is counted in the 30 mg group; one participant randomized to placebo who received 20 mg apremilast in error is counted in the 20 mg group for safety analyses.

Additional Information

Anne McClain

Celgene Corporation

Phone: 1-888-260-1599

Email: clinicaltrialdisclosure@celgene.com

Results disclosure agreements

• Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
• Publication restrictions are in place

Restriction type: OTHER