Trial Outcomes & Findings for A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia (NCT NCT00542386)

NCT ID: NCT00542386

Last Updated: 2026-01-08

Results Overview

The change from baseline to week 12

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

642 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	MCI-196: 3 g MCI-196: 3 g/ day	MCI-196: 6 g MCI-196: 6 g/ day	MCI-196: 9 g MCI-196: 9 g/ day	MCI-196: 12 g MCI-196: 12 g/ day	MCI-196: 15 g MCI-196: 15 g/ day	Pooled Placebo Placebo 9 tablets, 12 tablets and 15 tablets/ day
Overall Study STARTED	104	102	99	103	102	132
Overall Study COMPLETED	61	74	66	65	62	82
Overall Study NOT COMPLETED	43	28	33	38	40	50

Reasons for withdrawal

Reasons for withdrawal
Measure	MCI-196: 3 g MCI-196: 3 g/ day	MCI-196: 6 g MCI-196: 6 g/ day	MCI-196: 9 g MCI-196: 9 g/ day	MCI-196: 12 g MCI-196: 12 g/ day	MCI-196: 15 g MCI-196: 15 g/ day	Pooled Placebo Placebo 9 tablets, 12 tablets and 15 tablets/ day
Overall Study Adverse Event	1	7	7	8	13	4
Overall Study Death	0	0	1	2	1	2
Overall Study Lack of Efficacy	32	12	10	13	7	31
Overall Study Physician Decision	1	0	0	1	0	0
Overall Study Protocol Violation	0	0	1	0	0	4
Overall Study Withdrawal by Subject	5	8	10	11	15	7
Overall Study Other Reasons	4	1	4	3	4	2

Baseline Characteristics

A Study of MCI-196 in Chronic Kidney Disease Subjects on Dialysis With Hyperphosphatemia and Dyslipidaemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MCI-196: 3 g n=104 Participants MCI-196: 3 g/ day	MCI-196: 6 g n=102 Participants MCI-196: 6 g/ day	MCI-196: 9 g n=98 Participants MCI-196: 9 g/ day	MCI-196: 12 g n=102 Participants MCI-196: 12 g/ day	MCI-196: 15 g n=101 Participants MCI-196: 15 g/ day	Pooled Placebo n=132 Participants Placebo 9 tablets, 12 tablets and 15 tablets/ day	Total n=639 Participants Total of all reporting groups
Age, Continuous	49.9 years STANDARD_DEVIATION 12.20 • n=18 Participants	48.7 years STANDARD_DEVIATION 14.64 • n=17 Participants	47.3 years STANDARD_DEVIATION 12.55 • n=35 Participants	49.5 years STANDARD_DEVIATION 12.41 • n=42 Participants	50.7 years STANDARD_DEVIATION 11.34 • n=217 Participants	48.5 years STANDARD_DEVIATION 12.54 • n=1518 Participants	49.1 years STANDARD_DEVIATION 12.65 • n=5 Participants
Sex: Female, Male Female	48 Participants n=18 Participants	54 Participants n=17 Participants	48 Participants n=35 Participants	48 Participants n=42 Participants	46 Participants n=217 Participants	55 Participants n=1518 Participants	299 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=18 Participants	48 Participants n=17 Participants	50 Participants n=35 Participants	54 Participants n=42 Participants	55 Participants n=217 Participants	77 Participants n=1518 Participants	340 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: ITT: The ITT population included all subjects who received a randomisation number, took study medication, and had at least 1 central laboratory serum phosphorus or LDL-C value after the start

The change from baseline to week 12

Outcome measures

Outcome measures
Measure	MCI-196: 3 g n=104 Participants MCI-196: 3 g/ day	MCI-196: 6 g n=101 Participants MCI-196: 6 g/ day	MCI-196: 9 g n=97 Participants MCI-196: 9 g/ day	MCI-196: 12 g n=100 Participants MCI-196: 12 g/ day	MCI-196: 15 g n=99 Participants MCI-196: 15 g/ day	Pooled Placebo n=130 Participants Placebo 9 tablets, 12 tablets and 15 tablets/ day
The Change in Serum Phosphorus	-0.23 mg/dL Standard Deviation 1.62	-0.77 mg/dL Standard Deviation 1.97	-0.97 mg/dL Standard Deviation 1.68	-0.71 mg/dL Standard Deviation 1.84	-1.41 mg/dL Standard Deviation 1.43	-0.12 mg/dL Standard Deviation 1.70

PRIMARY outcome

Timeframe: 12 weeks

The percentage change from baseline to week 12

Outcome measures

Outcome measures
Measure	MCI-196: 3 g n=104 Participants MCI-196: 3 g/ day	MCI-196: 6 g n=101 Participants MCI-196: 6 g/ day	MCI-196: 9 g n=97 Participants MCI-196: 9 g/ day	MCI-196: 12 g n=100 Participants MCI-196: 12 g/ day	MCI-196: 15 g n=99 Participants MCI-196: 15 g/ day	Pooled Placebo n=130 Participants Placebo 9 tablets, 12 tablets and 15 tablets/ day
The Change in LDL-cholesterol	-16.66 Percent change Standard Deviation 20.05	-23.56 Percent change Standard Deviation 20.99	-27.64 Percent change Standard Deviation 21.45	-29.44 Percent change Standard Deviation 25.28	-27.46 Percent change Standard Deviation 24.57	2.77 Percent change Standard Deviation 17.44

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome data not reported

Adverse Events

MCI-196: 3 g

Serious events: 3 serious events

Other events: 47 other events

Deaths: 0 deaths

MCI-196: 6 g

Serious events: 1 serious events

Other events: 44 other events

Deaths: 0 deaths

MCI-196: 9 g

Serious events: 2 serious events

Other events: 49 other events

Deaths: 0 deaths

MCI-196: 12 g

Serious events: 7 serious events

Other events: 53 other events

Deaths: 0 deaths

MCI-196: 15 g

Serious events: 5 serious events

Other events: 59 other events

Deaths: 0 deaths

Pooled Placebo

Serious events: 8 serious events

Other events: 65 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MCI-196: 3 g n=104 participants at risk MCI-196: 3 g/ day	MCI-196: 6 g n=102 participants at risk MCI-196: 6 g/ day	MCI-196: 9 g n=98 participants at risk MCI-196: 9 g/ day	MCI-196: 12 g n=102 participants at risk MCI-196: 12 g/ day	MCI-196: 15 g n=101 participants at risk MCI-196: 15 g/ day	Pooled Placebo n=132 participants at risk Placebo 9 tablets, 12 tablets and 15 tablets/ day
Cardiac disorders Ischaemic cardiomyopathy	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Pericarditis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Atrial fibrillation	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Pyelonephritis chronic	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Cellulitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Upper respiratory tract infection	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Acute sinusitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Abscess limb	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Sepsis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Hepatitis B	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Mass	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Catheter site phlebitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Vascular disorders Hypertension	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Renal and urinary disorders Azotaemia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Renal and urinary disorders Renal failure chronic	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Eye disorders Iritis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Ascites	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Nausea	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Vomiting	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Abdominal pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Haemorrhoids	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Surgical and medical procedures Renal transplant	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Haemorrhagic stroke	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Eye injury	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Shunt thrombosis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Kidney rupture	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Procedural hypotension	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.

Other adverse events

Other adverse events
Measure	MCI-196: 3 g n=104 participants at risk MCI-196: 3 g/ day	MCI-196: 6 g n=102 participants at risk MCI-196: 6 g/ day	MCI-196: 9 g n=98 participants at risk MCI-196: 9 g/ day	MCI-196: 12 g n=102 participants at risk MCI-196: 12 g/ day	MCI-196: 15 g n=101 participants at risk MCI-196: 15 g/ day	Pooled Placebo n=132 participants at risk Placebo 9 tablets, 12 tablets and 15 tablets/ day
Blood and lymphatic system disorders Anaemia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Blood and lymphatic system disorders Haemorrhagic disorder	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Vascular disorders Hypertension	2.9% 3/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.9% 6/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	6.1% 6/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.0% 5/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 4/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Vascular disorders Hypertensive crisis	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Vascular disorders Hypotension	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Vascular disorders Aortic stenosis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Vascular disorders Haematoma	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.9% 3/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Vascular disorders Blood pressure fluctuation	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Vascular disorders Arteriosclerosis obliterans	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Headache	2.9% 3/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.9% 4/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 4/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Hypertonia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Hypotonia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Intercostal neuralgia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Tremor	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Uraemic neuropathy	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Paraesthesia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Convulsions local	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Encephalopathy	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Dizziness	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Dysgeusia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Somnolence	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Parosmia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Tonic convulsion	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Polyneuropathy	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Nervous system disorders Trigeminal neuralgia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Breast abscess	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Injection site abscess	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Urinary tract infection	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Upper respiratory tract infection	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Bacterial infection	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Varicella	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Gastroenteritis	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Laryngitis	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Nasopharyngitis	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Cystitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Cellulitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Bronchitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Vaginitis bacterial	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Cervicitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Salpingo-oophoritis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Influenza	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Pharyngitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Sinusitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Respiratory tract infection	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Helicobacter infection	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Herpes zoster	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Pulmonary tuberculosis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Respiratory tract infection viral	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.3% 3/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Oesophageal candidiasis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Hepatitis C	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Infections and infestations Viral infection	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Asthenia	3.8% 4/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.1% 3/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.9% 3/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	4.0% 4/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Pyrexia	3.8% 4/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Chills	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Chest discomfort	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Malaise	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Oedema peripheral	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Thirst	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Fatigue	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Catheter related complication	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
General disorders Non-cardiac chest pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Congestive cardiomyopathy	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Myocardial ischaemia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Ventricular extrasystoles	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Aortic valve calcification	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Angina pectoris	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Tachycardia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Extrasystoles	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Palpitations	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Conduction disorder	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Bradycardia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Atrioventricular block first degree	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Bundle branch block left	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 4/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Cough	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Toothache	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Diarrhoea	4.8% 5/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	4.9% 5/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	6.1% 6/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.9% 4/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.0% 5/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.3% 7/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Nausea	3.8% 4/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	8.8% 9/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	12.2% 12/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	18.6% 19/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	19.8% 20/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Hyperchlorhydria	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Flatulence	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.9% 3/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.3% 3/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Abdominal pain	2.9% 3/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	4.1% 4/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 3/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Frequent bowel movements	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Abdominal pain upper	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.9% 3/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.9% 3/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.9% 6/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Dyspepsia	3.8% 4/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	7.8% 8/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	7.1% 7/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	4.9% 5/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	8.9% 9/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Proctalgia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Constipation	2.9% 3/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	6.1% 6/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.0% 5/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Eructation	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Epigastric discomfort	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Irritable bowel syndrome	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Vomiting	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.9% 4/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	8.2% 8/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	10.8% 11/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.9% 6/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Abdominal discomfort	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 3/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Dry mouth	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 4/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Odynophagia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Abnormal faeces	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Dyschezia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Faecaloma	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Faeces discoloured	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Infrequent bowel movements	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Retching	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastritis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Abdominal distension	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.9% 3/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	6.9% 7/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.9% 6/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 4/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastritis erosive	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 3/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Painful defaecation	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Peritonitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastrointestinal hypermotility	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Defaecation urgency	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Faeces pale	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Haemorrhoids	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastric disorder	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Dysphagia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastric ulcer	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Tongue disorder	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Duodenitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastrointestinal sounds abnormal	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Arthritis	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Neck pain	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Pain in extremity	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Muscle spasms	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.8% 5/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Blood parathyroid hormone increased	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.3% 3/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Blood pressure increased	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Weight increased	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Weight decreased	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Blood phosphorus increased	2.9% 3/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.3% 3/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Cardiac murmur	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Body temperature increased	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Aspartate aminotransferase increased	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Blood creatine phosphokinase increased	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Blood pressure decreased	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Gamma-glutamyltransferase increased	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Carotid bruit	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Blood alkaline phosphatase increased	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Heart rate increased	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations ECG signs of myocardial ischaemia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Blood calcium decreased	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Investigations Blood phosphorus decreased	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Haemodialysis-induced symptom	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Procedural hypotension	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Contusion	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Traumatic haematoma	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Procedural hypertension	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.1% 3/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Extensive interdialytic weight gain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Operative haemorrhage	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Fall	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Ear injury	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Hyperphosphataemia	2.9% 3/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Decreased appetite	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.9% 6/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	4.0% 4/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Cachexia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Polydipsia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Hyperkalaemia	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.3% 3/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Hypocalcaemia	1.9% 2/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.1% 3/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	5.9% 6/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.3% 3/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Fluid retention	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Abnormal weight gain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Appetite disorder	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Metabolism and nutrition disorders Increased appetite	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Rash pruritic	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Pruritus	2.9% 3/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.9% 3/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	3.0% 4/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Cutaneous vasculitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Cutaneous lupus erythematosus	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Psychiatric disorders Sleep disorder	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Psychiatric disorders Insomnia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.5% 2/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Psychiatric disorders Anxiety	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Psychiatric disorders Hallucination, auditory	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Psychiatric disorders Decreased activity	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Psychiatric disorders Emotional distress	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Surgical and medical procedures Renal transplant	0.96% 1/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Surgical and medical procedures Nephrectomy	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Ear and labyrinth disorders Vertigo	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Reproductive system and breast disorders Menorrhagia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	2.0% 2/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Reproductive system and breast disorders Oligomenorrhoea	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Reproductive system and breast disorders Breast pain	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Endocrine disorders Hyperparathyroidism	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Endocrine disorders Hyperparathyroidism secondary	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Endocrine disorders Parathyroid disorder	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Endocrine disorders Hyperthyroidism	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Immune system disorders Hypersensitivity	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Immune system disorders Drug hypersensitivity	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Immune system disorders Kidney transplant rejection	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Eye disorders Conjunctivitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Eye disorders Visual acuity reduced	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	1.0% 1/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Eye disorders Eye haemorrhage	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Eye disorders Ocular hyperaemia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Eye disorders Myopia	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Hepatobiliary disorders Hepatitis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.98% 1/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Hepatobiliary disorders Cholelithiasis	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Hepatobiliary disorders Hepatitis toxic	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.99% 1/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.
Hepatobiliary disorders Biliary colic	0.00% 0/104 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/98 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/102 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.00% 0/101 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.	0.76% 1/132 • 12 weeks Each one subject in the MCI-196 9 g group, MCI-196 12 g group, and MCI-196 15 g group were randomised but did not receive any study medication. Therefore these 3 subjects were excluded for the safety evaluation.

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER