Following randomization, treatment will be administered for 5 weeks and change in the S-STS (primary outcome) will be measured weekly by the study physician as well as daily by the patients.
With the exception of one SAE in the Control group in which the participant was diagnosed with likely cow's milk protein intolerance, all SAEs were deemed unrelated to study formulas as assessed by study physicians.
Presumed causes (as ascertained clinically by study physicians) were recorded for 91% (98/108) of deaths.
Eight adverse events were classified by the study physician as being likely to be causally linked with the very low energy diet.
To aid in definitive classification, only patients identified during screening by a study physician as having clear clinical evidence of high-pressure (cardiogenic) or low-pressure (ALI/ARDS) pulmonary edema were enrolled, with the exclusion of ambiguous, intermediate cases.
Unstable medical conditions or severe behavioural disturbances, which did not allow participation in the study as judged by the study physicians, were criteria for exclusion as well as for discontinuation.
Intubations were performed or supervised by a study physician, defined as a physician with dual training in anaesthesia (board certified) and critical care (board certified or in the last year of training).
Referrals were categorized as follows: mild anemia, visual acuity disorders, hearing or middle ear disorders, behavioral disorders, developmental delay, problems requiring speech, physical or occupational therapy, HIV infection, dental problems and other disorders as determined by the study physicians.
All patients gave written informed consent and had a sore throat score of ≥6 on the Throat Soreness Scale at baseline and the presence of tonsillopharyngitis, as confirmed by the study physicians recording a score of ≥3 points on the expanded 21-point Tonsillopharyngitis Assessment (TPA).
