Patients maintained their insulin-administration regimen throughout the study, with the objective of maintaining glycated hemoglobin levels within the age-specified range according to the American Diabetes Association guidelines (8, 9).
The order of questionnaire administration remained consistent throughout the study (BMQ, MARS, CES-D).
Morphine administration was maintained throughout the study to avoid withdrawal effects.
The postprandial administration showed consistently less weight gain than preprandial administration throughout the 1-year study; however, this did not reach statistical significance at any time point.
Participants rated their symptoms at home before each administration of the study drug or placebo throughout the treatment period, so that a total of 10 to 15 measurements were obtained.
None of the patients developed adverse complications related to EPO administration, including thromboembolic events, throughout the study period.
The blood protein concentration decreased until 3 hours after endotoxin administration and then remained low throughout the study period (Table 2).
Vital signs, including mean arterial pressure (MAP) and heart rate (HR) were continuously monitored and recorded just prior to drug administration and every 5 minutes throughout the study.
From nasal swabs of two additional healthy control calves, which received a placebo saline administration, P. multocida was isolated throughout the study period.
Overall safety measurements, including physical examination, vital signs, electrocardiogram, determination of Eastern Cooperative Oncology Group performance status, laboratory studies and adverse experiences, were obtained and assessed before drug administration, and at designated intervals throughout the study.
