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Existing mediation analysis approaches for count and ZI count data often assume sequential ignorability of the mediator, which is often not plausible in health research because the mediator is not randomized by researchers.
Two studies were not randomized by current standards [ 28, 29].
These patients are small in number and were not randomized by HER2 status, but they were well balanced between the treatment groups.
Patients were not randomized by bronchoscopy posture and procedures were conducted based on operator preference, which we acknowledge has the potential to introduce various biases, including selection, operator, observer, and recall bias.
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As the VADT did not randomize by the use of rosiglitazone, two other methods were used: case control matching and 1 : 1 propensity matching.
Therefore, we did not randomize by permuting gene labels in the patient samples, as doing so would have resulted in a loss of biologically realistic relationships and an average correlation of close to zero every time.
Several limitations should be considered in this study performed by Lilly Germany: The treatment regimens were not randomized, but chosen by the treating psychiatrists according to the patient's individual need, which created selection bias in the way that we see patients with more severe symptoms accumulate in some groups while other cohorts comprise predominately the more stable ones.
If designed as a four-armed trial (randomized to being given the choice or not, and if not, randomized to treatment arm), as described by Howard and Thornicroft [ 34], the trial could also investigate the preference matching effect.
By design, the type of resuscitation provided was not randomized.
A record of all patients not randomized, including the reason for not being recruited, will be maintained by the investigator.
Some studies with a larger sample, such as that by Kanakura et al. [ 16], were not randomized.
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