Table 3 Blinding/masking details
Individuals | Information withheld | Method of blinding | Considerations |
|---|---|---|---|
Participants | Group assignment and study hypotheses | Similar appearance and packaging of medications | Participants will be unblinded through email after the trial is closed |
Principal investigators | Group assignment | - Concealed allocation schedule - Similar medications and packaging | They will be blinded until the end of the data analysis |
Randomization provider | Not blinded | - | She will not be involved in the rest of the trial |
Research assistants assigning participants | Group assignment, purposes and hypotheses of the study, and participant characteristics | - Concealed allocation schedule | They will not be involved in the rest of the trial |
Pharmacist | Not blinded | - | The pharmacist will not have a role in data analysis |
Statistician | Group assignment, participant, and group identities | Codes are given to participants and groups | - |
Nurses who make contact with participants | Group assignment, study hypotheses, and participant characteristics | - Concealed allocation schedule - Participants are given numerical identifiers | They will not have any role in data analysis or manuscript writing |
Data collectors | Not applicable | - | The data are patient-reported outcomes |
Manuscript writers | Not applicable | - | - |
Data and Safety Monitoring Committee (DSMC) | Group assignment | - Concealed allocation schedule | They can request to break the code for any participant at any time if needed |