1. Supplemental Figure S1 (A) (B) Any Statin ↓Randomisation
years old
- 200≤ TG ≤1000 mg/dL (2.3≤ TG ≤11.3 mmol/L)
- non-HDL-C ≥150 mg/dL (non-HDL-C ≥3.9 mmol/L )
↓Randomisation
Pitavastatin 2 mg/day + Placebo
Pitavastatin 2 mg/day + K mg/day
Pitavastatin
2 mg/day
Pitavastatin
2 mg/day
Pitavastatin 2 mg/day + K mg/day
Pitavastatin 2 mg/day + K mg/day
Pre-dose
≥4 w
Screening
<12 w
Treatment
12 w
Follow-up
4 w
(B)
- ≥20 years old
- 200≤ TG ≤1000 mg/dL (2.3≤ TG ≤11.3 mmol/L )
↓Randomisation
Any statin + Placebo
Any Statin
Any statin + K mg/day
Any statin + K mg/day
Any statin + K mg/day
Any statin + K mg/day
(if TG ≥ 150 mg/dL (1.7 mmol/L) at week 8) 　　　　
Screening
<8 w
Treatment
12 w
Treatment
12 w

2. Assessed for eligibility
Supplemental Figure S2
Assessed for eligibility
n = 751
Excluded
n = 563
Not meeting a selection criterion (369)
Meeting exclusion criteria (181)
Other reasons (13)
Randomised
n = 188
Placebo
n = 46
K-877
0.1 mg/day
n = 45
K-877
0.2 mg/day
n = 49
K-877
0.4 mg/day
n = 48
SAS/FAS
n = 46
Completed
n = 45
Discontinued
n = 1
Consent withdrawal (1)
SAS/FAS
n = 45
Completed
n = 43
Discontinued
n = 2
Adverse event (2)
SAS/FAS
n = 49
Completed
n = 47
Discontinued
n = 2
Adverse event (1)
Increase in LDL-C (1)
SAS/FAS
n = 48
Completed
PPS
n = 41
Excluded
n = 5
Protocol deviation (5)
PPS
n = 42
Excluded
n = 3
Protocol deviation (2)
Discontinuation (1)
PPS
n = 45
Excluded
n = 4
Protocol deviation (2)
Discontinuation (2)
PPS
n = 42
Excluded
n = 6
Protocol deviation (3)
Poor adherence (1)
TG data missing (2)
SAS, safety-analysis-set; FAS, full-analysis-set; PPS, per-protocol-set

3. Assessed for eligibility
Supplemental Figure S3
Assessed for eligibility
n = 818
Excluded
n = 395
Not meeting a selection criterion (253)
Meeting an exclusion criterion (88)
Other reasons (54)
Randomised
n = 423
Placebo
n = 108
K-877
0.2 mg/day
n = 150
K-877
0.2 (0.4) mg/day
n = 165
SAS/FAS
n = 108
Completed
n = 103
Discontinuation
n = 5
Consent withdrawal (2)
Adverse events (2)
Exacerbation of primary disease (1)
SAS/FAS
n = 150
Completed
n = 140
Discontinuation
n = 10
Consent withdrawal (3)
Adverse events (5)
Protocol deviation (2)
SAS/FAS
n = 165
Completed
n = 152
Discontinuation
n = 13
Consent withdrawal (4)
Adverse events (8)
Judged from the results of non-clinical studies (1)
SAS, safety-analysis-set; FAS, full-analysis-set

4. Supplemental Figure S4 2 4 8 12 16 20 24 (week)2 4 8 12 16 20 24
(week)
% Change in triglyceride level from baseline ** * *
***
***
***
***
***
***
***
***
***
***
***
***
***
***