Table 3.

Serious adverse events

	Placebo	Lithium	Total
None	51	46	97
1 event	41	42	83
2 events	14	16	30
3 events	1	3	4
Total	107	107	214

Data are number of patients. One patient had a serious adverse event between two screening visits and before signing the consent form. Because this event occurred before randomisation it has been excluded from the analysis. The relative risk of a serious adverse event (including death) in the lithium group compared with the placebo group was 1·09 (95% CI 0·58–1·39).