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Table 4 Elements of external validity
| Category | Specific items |
|---|---|
| Strain | e.g., Sprague-Dawley versus Fischer 344 |
| Species | Rat, mouse, dog, pig, etc. |
| Age | Age in weeks, body weight |
| Gender | Male versus female versus mix of genders used |
| Model of PAH | MCT, CH, or SUHx |
| Severity of PAH | RVSP or mPAP in control group |
| Cell preservation | Fresh versus fresh from previously cryopreserved versus thawed cryopreserved product |
| Tissue source of regenerative cell product | Bone marrow versus peripheral blood versus cord blood |
| Timing of cell administration following induction of PAH | Early (<2 weeks) versus late (≥2 weeks) intervention |
| Follow-up duration | Primary outcome assessed at 1, 2, 3, and 4+ weeks after intervention |
| Route of cell administration | Intravenous versus intratracheal versus intraperitoneal versus intramuscular |
| Dose of cells | e.g., 1 × 106 cells |
| Type of control | PBS versus normal saline versus fibroblasts versus heat-killed cells |
| Cell modification | Yes versus No |
| Number of participating study centers | Single versus multi-center |
