Personnel working in local health centres informed
patients about the study and recruited volunteers. In
addition, two advertisements were placed in local newspapers.
Recruiting occurred between 16 February 2009
and 14 January 2010. A nurse performed the preliminary
telephone or e-mail screenings, a physician met the
potential participants for screening, recruitment and
obtaining written informed consent and a pharmacist
(EC) randomized participants to blocks of eight to the
CRM group or to the placebo group according to a predetermined
ratio of 1 : 1. Randomization codes were not
decoded until the end of follow-up, 23 June 2010, to
ensure double-blinding during all parts of the trial,
including the follow-up. Participants were compensated
for their travelling expenses.