Trial Outcomes & Findings for S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000 (NCT NCT00784225)

NCT ID: NCT00784225

Last Updated: 2019-08-14

Results Overview

Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 13475 participants
• Primary outcome timeframe: Every 6 months, up to 7 years
• Results posted on: 2019-08-14

Participant Flow

Participant milestones

Measure	Selenium + Vitamin E Placebo Patients received selenium and vitamin E placebo daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	Selenium + Vitamin E Patients received selenium and vitamin E daily for 7 - 12 years Selenium: 200 mcg 1 pill by mouth daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years	Vitamin E Placebo + Selenium Placebo Patients received vitamin E placebo and selenium placebo daily for 7 - 12 years Vitamin E placebo:1 pill daily by mouth for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years	Vitamin E + Selenium Placebo Patients received vitamin E and selenium placebo daily for 7 - 12 years Vitamin E: 400 IU by mouth daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years
Overall Study STARTED	3375	3357	3369	3374
Overall Study COMPLETED	3375	3357	3369	3374
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

S0000B: Vitamin E and/or Selenium in Preventing Cataract and Age-Related Macular Degeneration in Men on SELECT SWOG-S0000

Baseline characteristics by cohort

Measure	Selenium + Vitamin E Placebo n=3375 Participants Selenium and vitamin E placebo daily for 7-12 years. Selenium: 200 mcg daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	Selenium + Vitamin E n=3357 Participants Selenium and vitamin E daily for 7-12 years. Selenium: 200 mcg daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years	Vitamin E Placebo + Selenium Placebo n=3369 Participants Vitamin E placebo and selenium placebo daily for 7-12 years. Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years	Vitamin E + Selenium Placebo n=3374 Participants Vitamin E and selenium placebo daily for 7-12 years. Vitamin E: 400 IU daily by mouth for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years	Total n=13475 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62 years n=7 Participants	62 years n=5 Participants	62 years n=4 Participants	62 years n=21 Participants
Age, Customized 50-54 years	134 Participants n=5 Participants	160 Participants n=7 Participants	159 Participants n=5 Participants	155 Participants n=4 Participants	608 Participants n=21 Participants
Age, Customized 55-64 years	1951 Participants n=5 Participants	1964 Participants n=7 Participants	1959 Participants n=5 Participants	2027 Participants n=4 Participants	7901 Participants n=21 Participants
Age, Customized 65-74 years	1065 Participants n=5 Participants	1067 Participants n=7 Participants	1061 Participants n=5 Participants	993 Participants n=4 Participants	4186 Participants n=21 Participants
Age, Customized >=75 years	225 Participants n=5 Participants	166 Participants n=7 Participants	190 Participants n=5 Participants	199 Participants n=4 Participants	780 Participants n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	3375 Participants n=5 Participants	3357 Participants n=7 Participants	3369 Participants n=5 Participants	3374 Participants n=4 Participants	13475 Participants n=21 Participants
Race/Ethnicity, Customized White	2753 Participants n=5 Participants	2756 Participants n=7 Participants	2750 Participants n=5 Participants	2763 Participants n=4 Participants	11022 Participants n=21 Participants
Race/Ethnicity, Customized Non-white	622 Participants n=5 Participants	601 Participants n=7 Participants	619 Participants n=5 Participants	611 Participants n=4 Participants	2453 Participants n=21 Participants
Education (highest level) <= High school graduate or GED	653 Participants n=5 Participants	641 Participants n=7 Participants	706 Participants n=5 Participants	656 Participants n=4 Participants	2656 Participants n=21 Participants
Education (highest level) Some college/vocational school	943 Participants n=5 Participants	943 Participants n=7 Participants	948 Participants n=5 Participants	964 Participants n=4 Participants	3798 Participants n=21 Participants
Education (highest level) >College graduate	1759 Participants n=5 Participants	1752 Participants n=7 Participants	1705 Participants n=5 Participants	1738 Participants n=4 Participants	6954 Participants n=21 Participants
Education (highest level) Unknown/missing	20 Participants n=5 Participants	21 Participants n=7 Participants	10 Participants n=5 Participants	16 Participants n=4 Participants	67 Participants n=21 Participants
Cigarette smoking Never	1451 Participants n=5 Participants	1419 Participants n=7 Participants	1366 Participants n=5 Participants	1457 Participants n=4 Participants	5693 Participants n=21 Participants
Cigarette smoking Current	248 Participants n=5 Participants	278 Participants n=7 Participants	319 Participants n=5 Participants	268 Participants n=4 Participants	1113 Participants n=21 Participants
Cigarette smoking Former	1670 Participants n=5 Participants	1654 Participants n=7 Participants	1681 Participants n=5 Participants	1642 Participants n=4 Participants	6647 Participants n=21 Participants
Cigarette smoking Unknown	6 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	22 Participants n=21 Participants
Alcohol use Rarely/never	50 Participants n=5 Participants	51 Participants n=7 Participants	66 Participants n=5 Participants	59 Participants n=4 Participants	226 Participants n=21 Participants
Alcohol use >=1 drink/month	3325 Participants n=5 Participants	3304 Participants n=7 Participants	3303 Participants n=5 Participants	3314 Participants n=4 Participants	13246 Participants n=21 Participants
Alcohol use Unknown	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Body mass index (kg/m^2) <25	674 Participants n=5 Participants	666 Participants n=7 Participants	675 Participants n=5 Participants	626 Participants n=4 Participants	2641 Participants n=21 Participants
Body mass index (kg/m^2) 25-<30	1574 Participants n=5 Participants	1607 Participants n=7 Participants	1591 Participants n=5 Participants	1606 Participants n=4 Participants	6378 Participants n=21 Participants
Body mass index (kg/m^2) >=30	1127 Participants n=5 Participants	1084 Participants n=7 Participants	1103 Participants n=5 Participants	1142 Participants n=4 Participants	4456 Participants n=21 Participants
History of hypertension Yes	1339 Participants n=5 Participants	1320 Participants n=7 Participants	1374 Participants n=5 Participants	1301 Participants n=4 Participants	5334 Participants n=21 Participants
History of hypertension No	2036 Participants n=5 Participants	2037 Participants n=7 Participants	1995 Participants n=5 Participants	2073 Participants n=4 Participants	8141 Participants n=21 Participants
Aspirin use Yes	1484 Participants n=5 Participants	1454 Participants n=7 Participants	1505 Participants n=5 Participants	1481 Participants n=4 Participants	5924 Participants n=21 Participants
Aspirin use No	1891 Participants n=5 Participants	1903 Participants n=7 Participants	1864 Participants n=5 Participants	1893 Participants n=4 Participants	7551 Participants n=21 Participants
Statin use Yes	884 Participants n=5 Participants	886 Participants n=7 Participants	900 Participants n=5 Participants	914 Participants n=4 Participants	3584 Participants n=21 Participants
Statin use No	2464 Participants n=5 Participants	2447 Participants n=7 Participants	2451 Participants n=5 Participants	2434 Participants n=4 Participants	9796 Participants n=21 Participants
Statin use Unknown	27 Participants n=5 Participants	24 Participants n=7 Participants	18 Participants n=5 Participants	26 Participants n=4 Participants	95 Participants n=21 Participants
History of diabetes Yes	353 Participants n=5 Participants	348 Participants n=7 Participants	380 Participants n=5 Participants	339 Participants n=4 Participants	1420 Participants n=21 Participants
History of diabetes No	3022 Participants n=5 Participants	3009 Participants n=7 Participants	2989 Participants n=5 Participants	3035 Participants n=4 Participants	12055 Participants n=21 Participants
Records sought Yes	635 Participants n=5 Participants	624 Participants n=7 Participants	624 Participants n=5 Participants	629 Participants n=4 Participants	2512 Participants n=21 Participants
Records sought No	2740 Participants n=5 Participants	2733 Participants n=7 Participants	2745 Participants n=5 Participants	2745 Participants n=4 Participants	10963 Participants n=21 Participants
Included in cataract analysis Yes	2805 Participants n=5 Participants	2789 Participants n=7 Participants	2829 Participants n=5 Participants	2844 Participants n=4 Participants	11267 Participants n=21 Participants
Included in cataract analysis No	570 Participants n=5 Participants	568 Participants n=7 Participants	540 Participants n=5 Participants	530 Participants n=4 Participants	2208 Participants n=21 Participants
Included in AMD analysis Yes	3348 Participants n=5 Participants	3342 Participants n=7 Participants	3355 Participants n=5 Participants	3344 Participants n=4 Participants	13389 Participants n=21 Participants
Included in AMD analysis No	27 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	30 Participants n=4 Participants	86 Participants n=21 Participants

PRIMARY outcome

Timeframe: Every 6 months, up to 7 years

Population: Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.

Visually significant age-related AMD was defined as incident AMD responsible for reduction in best corrected visual acuity to 20/30 or worse(AMD 20/30)

Outcome measures

Measure	AMD: Selenium Active n=6690 Participants Patients received selenium and either Vitamin E or vitamin E placebo daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Selenium Placebo n=6699 Participants Patients received selenium placebo and either Vitamin E or vitamin E placebo daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Vitamin E Active n=6686 Participants Patients received vitamin E and either selenium or selenium placebo daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Vitamin E Placebo n=6703 Participants Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years
Number of Participants With Visually Significant Age-related Macular Degeneration (AMD) AMD cases	9 Participants	12 Participants	9 Participants	12 Participants
Number of Participants With Visually Significant Age-related Macular Degeneration (AMD) non-AMD cases	6681 Participants	6687 Participants	6677 Participants	6691 Participants

PRIMARY outcome

Timeframe: Every 6 months, up to 7 years

Population: Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.

Incident cataract was defined as lens opacity diagnosed after randomization but prior to end of study, age-related in origin, and best-corrected visual acuity of 20/30 or worse attributable to the opacity.

Outcome measures

Measure	AMD: Selenium Active n=5594 Participants Patients received selenium and either Vitamin E or vitamin E placebo daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Selenium Placebo n=5673 Participants Patients received selenium placebo and either Vitamin E or vitamin E placebo daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Vitamin E Active n=5633 Participants Patients received vitamin E and either selenium or selenium placebo daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Vitamin E Placebo n=5634 Participants Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years
Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30 Cataract cases	185 Participants	204 Participants	197 Participants	192 Participants
Number of Participants With Cataract and Best Corrected Visual-acuity of 20/30 non-cataract cases	5409 Participants	5469 Participants	5436 Participants	5442 Participants

SECONDARY outcome

Timeframe: Every 6 months, up to 7 years

Population: Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.

Advanced AMD was defined as the occurrence of disciform scars, or geographic atrophy or retinal pigment epithelium (RPE) detachment in either or both eyes at AMD diagnosis.

Outcome measures

Measure	AMD: Selenium Active n=6690 Participants Patients received selenium and either Vitamin E or vitamin E placebo daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Selenium Placebo n=6699 Participants Patients received selenium placebo and either Vitamin E or vitamin E placebo daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Vitamin E Active n=6686 Participants Patients received vitamin E and either selenium or selenium placebo daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Vitamin E Placebo n=6703 Participants Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years
Number of Participants With Advanced AMD Advanced AMD cases	10 Participants	4 Participants	7 Participants	7 Participants
Number of Participants With Advanced AMD non-advanced AMD cases	6680 Participants	6695 Participants	6679 Participants	6696 Participants

SECONDARY outcome

Timeframe: Every 6 months, up to 7 years

Population: Marginal analyses were performed with arms pooled based on active vs. placebo selenium or vitamin E.

Cataract extraction was defined as the surgical removal of an incident cataract.

Outcome measures

Measure	AMD: Selenium Active n=5594 Participants Patients received selenium and either Vitamin E or vitamin E placebo daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Selenium Placebo n=5673 Participants Patients received selenium placebo and either Vitamin E or vitamin E placebo daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Vitamin E Active n=5633 Participants Patients received vitamin E and either selenium or selenium placebo daily for 7 - 12 years Vitamin E: 400 IU daily by mouth for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years	AMD: Vitamin E Placebo n=5634 Participants Patients received vitamin E placebo and either selenium or selenium placebo daily for 7 - 12 years Vitamin E placebo: 1 pill by mouth daily for 7 - 12 years Selenium: 200 mcg daily for 7 - 12 years Selenium placebo: 1 pill by mouth daily for 7 - 12 years
Number of Participants Who Underwent Cataract Extraction Cataract extraction cases	99 Participants	120 Participants	114 Participants	105 Participants
Number of Participants Who Underwent Cataract Extraction non-cataract extraction cases	5495 Participants	5553 Participants	5519 Participants	5529 Participants

Adverse Events

Selenium + Vitamin E Placebo

Serious events: 44 serious events

Other events: 243 other events

Deaths: 151 deaths

Selenium + Vitamin E

Serious events: 41 serious events

Other events: 243 other events

Deaths: 159 deaths

Placebo

Serious events: 50 serious events

Other events: 261 other events

Deaths: 150 deaths

Vitamin E + Selenium Placebo

Serious events: 45 serious events

Other events: 267 other events

Deaths: 147 deaths

Serious adverse events

Measure	Selenium + Vitamin E Placebo n=3374 participants at risk Selenium + Vitamin E placebo	Selenium + Vitamin E n=3356 participants at risk Selenium + Vitamin E	Placebo n=3366 participants at risk Placebo	Vitamin E + Selenium Placebo n=3374 participants at risk Vitamin E + Selenium placebo
Cardiac disorders Arrhythmia, NOS	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Cardiac disorders Cardiac ischemia/infarction	0.33% 11/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.27% 9/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.27% 9/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.24% 8/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Cardiac disorders Cardiovascular-other	0.21% 7/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.27% 9/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.45% 15/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.36% 12/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Cardiac disorders Conduction abnormality/block	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Cardiac disorders LVEF decrease/CHF	0.06% 2/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Cardiac disorders Supraventricular arrhythmia	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Cardiac disorders Ventricular arrhythmia	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.09% 3/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.06% 2/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Eye disorders Eye-other	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Eye disorders Vision,NOS	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Gastrointestinal disorders GI-other	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Gastrointestinal disorders Melena/ GI bleeding	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
General disorders Constitutional symptoms-other	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
General disorders Hemorrhage w/o 3-4 thrombocyt	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
General disorders Reportable adverse event, NOS	0.24% 8/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.21% 7/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.33% 11/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.24% 8/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Hepatobiliary disorders Liver-clinical	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Infections and infestations Respiratory infect w/o neutrop	0.06% 2/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Infections and infestations Respiratory infection, unk ANC	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Injury, poisoning and procedural complications Surgery-hemorrhage	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Investigations Weight gain	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary	0.09% 3/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.12% 4/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Nervous system disorders CNS hemorrhage	0.06% 2/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.06% 2/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.09% 3/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Nervous system disorders Cerebrovascular ischemia	0.06% 2/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.12% 4/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.12% 4/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Nervous system disorders Seizures	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Nervous system disorders Sensory neuropathy	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Respiratory, thoracic and mediastinal disorders Emphysema/COPD	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Vascular disorders Carotid stenosis	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Vascular disorders Peripheral arterial ischemia	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.
Vascular disorders Thrombosis/embolism	0.00% 0/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.00% 0/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	0.03% 1/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.

Other adverse events

Measure	Selenium + Vitamin E Placebo n=3374 participants at risk Selenium + Vitamin E placebo	Selenium + Vitamin E n=3356 participants at risk Selenium + Vitamin E	Placebo n=3366 participants at risk Placebo	Vitamin E + Selenium Placebo n=3374 participants at risk Vitamin E + Selenium placebo
Cardiac disorders Cardiac ischemia/infarction	7.2% 243/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	7.2% 243/3356 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	7.8% 261/3366 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.	7.9% 267/3374 • Every 6 months while the participant is receiving study supplements, up to 7 years There are no Adverse Events (AE) associated with this trial. All AEs were reported for the parent trial (SELECT - S0000). Included below are the AEs for the participants on this trial that were included in the primary analysis. These AEs were also reported for the parent trial.

Additional Information

SELECT/S0000B Statistician

SWOG Statistical Center

Phone: 2066674623

Email: adarke@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60