German law does not require patient informed consent in observational studies in which treatment is medically indicated by the physician regardless of study participation and in which treatment use is restricted to approved indications.
A further comparison with the international literature aimed at the economics of CAM therapies shows that research in this field is almost entirely restricted to specific indications and procedures[ 6], whereas studies adopting health system perspective are currently of low quality if not lacking at all[ 7].
These patients should all have been diagnosed with COPD since in Belgium reimbursement of tiotropium is restricted to this indication.
Until now, the use of NDIs has been restricted to certain defined indications with comparable low occlusal loading like incisors or as retaining elements for overdentures.
However, so far, FISH is restricted to very few indications for which protocols have been described.
However, warnings of possible hepatotoxicity were added to the US labelling in 2007, and in 2008, moxifloxacin was restricted to second line indications in Europe [ 72].
Moreover, in the current clinical routine the use of this drug is no longer restricted to the approved indication, but has been extended to a wide variety of inflammatory skin diseases including some with the potential of malignant transformation.
The excess risk among PPI users was largely restricted to patients with ulcer indications.
Since less than 16% of the cohort show clinical indications for diabetes, analyses of other potential risk factors were restricted to those with no indication of diabetes.
In the sensitivity analysis restricted to cases with any indication of a positive ER and PR expression versus a complete absence of ER and PR expression with reproductive factors showed similar patterns with risk of joint ER+PR+ and ER-PR- breast cancer subtypes (data not shown).
To prevent an overload of requests, the diagnostic indications were restricted to dyspnoea, cardiac murmur and peripheral oedema.
