CONSORT 2010 Flow Diagram
Passed phone pre-screening;
presented for screening (n
t= 159; n
m=109; n
f= 50)
Excluded (n
t= 7; n
m= 6; n
f= 1)
Declined to participate (nm = 6; nf = 1)
Analysed
For objective safety measures: all males who were randomized, received the intervention, and for whom measures were obtained
(n
m< 49)
For adverse event/symptom reports:
all males who received the spray and completed at least one symptom assessment
(n
m= 49)
Lost to follow-up (n
t= 3; n
m= 3; n
f=0)
Could not be reached (nm = 3)
Oxytocin (n
t= 75; n
m= 50; n
f=25)
Received intervention (nt = 74; nm = 49; nf =25)
Did not receive intervention (nm = 1)
Lost to follow-up (n
t= 6; n
m= 6)
Could not be reached (nm = 6)
Placebo (n
t= 69; n
m= 46; n
f=23)
Received intervention (nt = 68; nm = 46; nf =22)
Did not receive intervention (nf =1)
Analysed
For objective safety measures: all males who were randomized, received the intervention, and for whom measures were obtained
(n
m< 46)
For adverse event/symptom reports:
all males who received the spray and completed at least one symptom assessment
(n
m= 44)
Allocation
Analysis Follow-Up
Randomized (n
t= 144; n
m= 96; n
f=48)
Enrollment
Pre-Intervention Assessments
Excluded (n
t= 8; n
m= 7; n
f=1)
Withdrew participation (nm = 4; nf =1)
Other reasons (nm = 3)
Discontinued intervention (n
t= 1; n
m= 1)
Experience of adverse event (nm = 1)
Discontinued intervention (n
t= 7; n
m= 3; n
f=4)
Experience of adverse event (nm =2; nf =4)
Unrelated medical issue (nm = 1)
Post-Intervention Assessments
Excluded (n
t= 1; n
m= 1)
Withdrew participation
(n
m= 1)
Note: Subscripts t, f, and m, refer to total sample, females, and males, respectively.
Article: Safety and tolerability of chronic intranasal oxytocin in older men: Results from a randomized controlled trial.
Journal: Psychopharmacology
Authors: Rung, J. M., Horta, M., Tammi, E. M., Perez, E., Ojeda, M. C., Lin, T., Harris, G., Somerville, J., Salmeron, D., Beltz, S.E., Sandesara, B., Feifel, D., & Ebner, N. C.
Corresponding Authors:
Natalie C. Ebner, University of Florida, Department of Psychology Email: natalie.ebner@ufl.edu
Jillian M. Rung, University of Florida, Departments of Epidemiology and Psychology Email: jrung@ufl.edu, rung.jillian@gmail.com
