Table 4.

Adverse events by follow-up timepoint and intervention group

		Placebo group					Losartan group
		14 days (n=106)	3 months (n=106)	6 months (n=101)	9 months (n=100)	12 months (n=100)	14 days (n=104)	3 months (n=104)	6 months (n=101)	9 months (n=99)	12 months (n=96)
Any adverse event		32 (30%)	43 (41%)	46 (46%)	41 (41%)	45 (45%)	30 (29%)	51 (49%)	46 (46%)	45 (45%)	37 (39%)
Any serious adverse event		2 (2%)	4 (4%)	6 (6%)	4 (4%)	4 (4%)	2 (2%)	1 (1%)	9 (9%)	2 (2%)	6 (6%)
Serious adverse event
	Mechanical injury	1 (1%)	0	0	2 (2%)	0	0	0	1 (1%)	2 (2%)	0
	Infection	0	0	0	0	1 (1%)	0	0	5 (5%)	0	1 (1%)
	Neuropsychiatric	0	1 (1%)	1 (1%)	1 (1%)	0	0	1 (1%)	1 (1%)	0	0
	Gastrointestinal	0	0	2 (2%)	0	1 (1%)	0	0	0	0	1 (1%)
	Other	1 (1%)	3 (3%)	3 (3%)	1 (1%)	2 (2%)	2 (2%)	0	2 (2%)	0	4 (4%)

Data are n (%). Additional information on adverse events is in the appendix pp 4, 5. Three serious adverse events are not included in this table, because they occurred before randomisation and, thus, the main phase of the study during which the primary outcomes are reported. Two of these were in participants during the open-label phase of the study but were included in the main trial (both randomised to intervention), and one participant who did not proceed to the randomised phase.