How many patients received a tonic trial before being implanted with an SJM device in the SUNBURST study?

In the SUNBURST study, it is documented that all patients were required to receive a tonic trial prior to the implantation of the SJM device. This uniformity ensures that clinicians could gather comprehensive data about patient responses and determine suitability for the device based on the outcomes of the tonic trial.

Implementing a tonic trial for every patient allows researchers to maintain consistency in the study's methodology, enhancing the reliability of the results. The approach effectively assesses how patients might respond to the device before actual implantation, thereby maximizing safety and therapeutic effectiveness. This requirement is pivotal in clinical study design, ensuring that all participants have undergone the same preparatory steps.

The other options suggest varying degrees of patient involvement in the tonic trial process, which does not align with the protocol followed in the SUNBURST study. Each of those alternatives implies a lack of comprehensive trial assessment among certain patients, which is not accurate in the context of this particular study's methodology. The requirement for all patients to undergo a tonic trial before receiving the SJM device underscores the study's rigor and commitment to patient safety and optimal outcomes.