Study population and intervention
ADVERSE EVENT
In brief, eligible participants were adult patients on chronic dialysis treatment not treated with vitamin K antagonists, recombinant parathyroid hormones, anti-osteoporotic drugs or vitamin K supplements. Participants were excluded during follow-up if they initiated vitamin K antagonist treatment, were <50% adherent to or had non-acceptable side effects from the study tablets or received a kidney transplant. Informed consent was obtained from all participants included in the study.Participants were randomised to receive one daily tablet containing 360 µg MK-7 or a visually identical placebo tablet using concealed block randomisation with blocks of four (2:2). Each block consisted of patients treated with the same dialysis modality at the same dialysis centre. Double blinding was maintained until the last patient's last visit.Kappa Bioscience AS, Oslo, Norway, produced the synthetic MK-7 (K2VITAL Delta), according to the Hazard Analysis Critical Control Point principles, and Orkla Care AS, Ishøj, Denmark, produced all tablets used in the study.Adverse events (AEs) and serious AEs (SAEs) were monitored according to the procedure described in Supplementary Table 2S.