| Is the population based on a representative sample selected from a relevant population? | Yes | All participants from the initial blinded period were eligible to enter the crossover phase of the study | Yes | All participants from previous phases were eligible for follow-up |
| Are the criteria for inclusion explicit? | Yes | All participants from the initial blinded period were eligible to enter the crossover phase of the study | Yes | All participants from previous phases were eligible for follow-up |
| Were groups similar at baseline in terms of important confounding variables? If not, was the analysis adjusted to account for the imbalance? | NA | This phase of the study did not aim for comparative analysis | NA | This phase of the study did not aim for comparative analysis |
| Was knowledge of the allocated intervention by outcome assessors adequately prevented during the study? | Yes | The sponsor, investigative study sites and participants remained blinded to treatment assignment until the last participant enrolled had completed the study | Yes | The sponsor, investigative study sites and participants remained blinded to treatment assignment until the last participant enrolled had completed the week 60 evaluations and the database was locked |
| Were losses to follow-up < 20%? | Yes | Only 7 out of 110 participants withdrew by the end of this phase | Unclear | The total loss to follow-up or withdrawals at this phase of the study were not reported |
| Were all patients accounted for at the end of study follow-up? | Yes | Withdrawals and reasons (e.g. AEs, death and lack of efficacy) were reported | Unclear | The total loss to follow-up for this phase of the study was not reported |
| Were reliable methods used to measure outcomes? | Yes | PASI scores were reported | NA | The follow-up was aimed only at safety reports |
| Was the study sufficiently powered to detect a treatment effect? | NA | The follow-up period did not aim for comparative analyses | NA | The follow-up period did not aim for comparative analyses |
| Was the study follow-up duration sufficient to detect a long-term treatment effect? | Yes | Participants were followed up for 40 weeks | No | Participants were followed up for only 8 weeks |
