| Home 2005 |
Low risk of bias |
A 1:1 randomisation schedule was generated by the sponsor. This schedule paired sequential numbers with treatment codes allocated at random. The schedule was prepared by centre on a 1:1 basis. An independent agency was used for central telephone randomisation. There were no relevant baseline imbalances. |
Low risk of bias |
Open‐label trial design. A modified intention‐to‐treat analysis was applied (participants with at least one measurement after baseline). |
Low risk of bias |
Withdrawals and reasons for withdrawal were documented, did not differ substantially between intervention groups and did not appear to be related to health status. Modified intention‐to‐treat analysis set was used (efficacy was analysed using those intention‐to‐treat (ITT) participants for whom both a pre‐treatment and an on‐treatment value were available, with the exception of hypoglycaemia, for which the entire ITT population was analysed). |
Low risk of bias |
Open‐label design with outcome measure unlikely influenced by lack of blinding. |
Low risk of bias |
Data from full clinical study report. Only one measurement and result provided for the time point selected by review authors. |
Low risk of bias |
No risk of bias identified. |
