This requires a meta-analysis of important CV events in phase 2/3 to achieve an upper 95% CI of <1.3 to qualify for approval without requiring a postmarketing CV trial, provided that overall benefit and risk support approval (Fig. 2).
Valuable insights can be gleaned from including non-randomized trials, provided that attention is paid to the risk of confounders and heightened bias 14.
Nevertheless, Potts "seems to give a generally trustworthy, although not comprehensive, account of an Assize witchcraft trial, provided that the reader is constantly aware of his use of written material instead of verbatim reports".
Cognitive impairment was not an exclusion criterion for the WSD telehealth trial, provided that an informal carer was available to assist with use of the telehealth system.
This past week, at a pre-trial hearing for five young Somali-Americans accused of attempting to join the Islamic State in Iraq and al-Sham (ISIS), U.S. District Court Judge Michael Davis announced that he would consider moving the men from prison to a halfway house while they awaited trial, provided that their lawyers could come up with a satisfactory "creative release" plan.
The system allowed patients with either extensive disease or a poor performance status to be included on trial provided that this was the only adverse prognostic factor.
Patients with a positive pLDH-based RDT were included in the trial, provided that full written informed consent was given by the patient or carer.
Patients transferred from one ICU to another ICU, will remain in the trial provided that the receiving ICU also participates in this trial.
Where it was thought to be unlikely that an adverse event was related to the treatment, the dog was allowed to continue with the trial, provided that the owners agreed.
All patients with minor depression or mild major depression (3 to 6 depression symptoms according to DSM-IV-TR criteria) will be included in the trial, provided that they meet the other inclusion and exclusion criteria.
