A limitation of the present study is the small
sample size. This is also the probable reason for
the difference in the number of participants in
the Resperate group and the CD group as neither
the investigator nor the patient had any possibility
to know or influence the content of the envelope or
the order in which they were opened. The differences
in baseline characteristics of the patients
in the Resperate and CD group may be an effect
of the randomization and inclusion criteria of the
study.