| Title and abstract |
1c |
Indicate whether this study was conducted during the force majeure event in the abstract |
| Methods |
|
|
| Participants |
4c |
Specify the study locations (such as community clinics and academic hospitals) in the supplement, including whether the study sites were affected by the force majeure event after trial commencement |
|
4d |
If 4b includes remote data capture, describe the data collection process |
| Interventions |
5b |
Any changes to protocol interventions due to the force majeure event, with reasons |
| Sample size |
7c |
If yes to 6b and if 7b is applicable, did the changes to trial outcomes happen before or after a pre-planned interim analysis |
| Statistical methods |
12b |
Methods for additional analyses, such as subgroup analyses, adjusted analyses, and sensitivity analyses |
|
12c |
Methods for addressing missing data |
| Results |
|
|
| Participant flow (a diagram is strongly recommended) |
13c |
For each group, the numbers of participants experiencing treatment delay, with reasons |
| Recruitment |
14a |
Dates defining the periods of recruitment, treatment, and follow-up |
|
14c |
Indicate whether the force majeure event impacted the study accrual rate |
| Ancillary analyses |
18 |
Results of any other analyses performed, including subgroup analyses, adjusted analyses, and sensitivity analyses, distinguishing pre-specified from exploratory |
| Harms |
19b |
If applicable, are the adverse events associated with the force majeure event |
|
19c |
If applicable, for each group, the numbers of participants experiencing laboratory test delays for assessing adverse events, with reasons |
| Discussion |
|
|
| Interpretation |
22 |
Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence and the impact of the force majeure event |
