In that study, baseline hospitalization rates varied considerably between the randomization groups.
Baseline characteristics were equally distributed between the randomization groups, and none of the outcomes differed significantly between the randomization groups.
To investigate the possible effect modifications, relevant interactions will be included, among these interactions between the randomization group and time since baseline, time since diagnosis, and baseline values of outcomes.
The patients complete baseline measurements before the randomization.
In addition, explorative subgroup analyses will be performed, based on the interaction between the randomization variable and various different baseline variables (table 3).
In addition, our randomization strategy served to level out differences in participants' symptoms at baseline between the conditions, as such differences might also influence participation in exercise sessions.
Univariate analysis showed statistical relations between baseline LIS, randomization group, level of PEEP, the number of blood products, ALI/ARDS risk factor, and the baseline IL-6 lavage-fluid level with development of lung injury.
The time between baseline measurements/ randomization and first treatment visit was 97 days (median, P25 –P75: 65–125) and was not different between both groups (p = .25).25
Attrition between baseline and randomization is currently 2 (4.8%).
Third, because we did not treat the baseline BMI as a balancing factor at the randomization, the difference in the baseline BMI between the group, although it was not statistically significant, might also bring about study bias.
